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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00976937
Registration number
NCT00976937
Ethics application status
Date submitted
14/09/2009
Date registered
15/09/2009
Date last updated
11/10/2016
Titles & IDs
Public title
24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years
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Scientific title
A Randomized, Double-blind, Double-dummy, 2-arm Parallel-group, Multicenter 24-week Study Comparing the Efficacy and Safety of AVE0010 to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 and Not Adequately Controlled With Metformin
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Secondary ID [1]
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EudraCT:2008-007 334-22
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Secondary ID [2]
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EFC10780
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Lixisenatide (AVE0010)
Treatment: Drugs - Lixisenatide Placebo
Treatment: Devices - Pen auto-injector
Treatment: Drugs - Sitagliptin
Treatment: Drugs - Sitagliptin Placebo
Treatment: Drugs - Metformin
Experimental: Lixisenatide - 2-step initiation regimen of lixisenatide along with sitagliptin placebo: lixisenatide 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24 along with placebo matching to sitagliptin 100 milligram (mg) capsule orally QD up to Week 24.
Active Comparator: Sitagliptin - Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo: sitagliptin 100 mg capsule orally QD up to Week 24 along with volume matching lixisenatide placebo 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
Treatment: Drugs: Lixisenatide (AVE0010)
Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
Treatment: Drugs: Lixisenatide Placebo
Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
Treatment: Devices: Pen auto-injector
Treatment: Drugs: Sitagliptin
Administered orally once a day in the morning with or without food at approximately the same time each day.
Treatment: Drugs: Sitagliptin Placebo
Administered orally once a day in the morning with or without food at approximately the same time each day.
Treatment: Drugs: Metformin
Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% and at Least 5% Weight Loss From Baseline at Week 24
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Assessment method [1]
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Percentage of patients who met both criteria (HbA1c <7% at Week 24 and at least 5% weight loss from baseline at Week 24) is reported. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.
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Timepoint [1]
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Week 24
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Secondary outcome [1]
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Absolute Change From Baseline in HbA1c at Week 24
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Assessment method [1]
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Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.
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Timepoint [1]
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Baseline, Week 24
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Secondary outcome [2]
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Change From Baseline in Body Weight at Week 24
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Assessment method [2]
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Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.
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Timepoint [2]
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Baseline, Week 24
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Secondary outcome [3]
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Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) at Week 24
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Assessment method [3]
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The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.
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Timepoint [3]
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Baseline, Week 24
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Secondary outcome [4]
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Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
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Assessment method [4]
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Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.
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Timepoint [4]
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Baseline, Week 24
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Secondary outcome [5]
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Change From Baseline in Glucose Excursion at Week 24
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Assessment method [5]
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Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.
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Timepoint [5]
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Baseline, Week 24
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Secondary outcome [6]
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Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin (PPI) at Week 24
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Assessment method [6]
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Change was calculated for fasting plasma insulin and 2-hour post prandial plasma insulin by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.
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Timepoint [6]
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Baseline, Week 24
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Secondary outcome [7]
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Change From Baseline in Fasting C-peptide and 2-hour Postprandial C-peptide at Week 24
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Assessment method [7]
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Change was calculated for fasting C-peptide and 2-hour postprandial C-peptide by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.
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Timepoint [7]
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Baseline, Week 24
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Secondary outcome [8]
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Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24
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Assessment method [8]
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Change was calculated for fasting glucagon and 2-hour postprandial glucagon by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.
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Timepoint [8]
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Baseline, Week 24
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Secondary outcome [9]
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Change From Baseline in Fasting Proinsulin and 2-hour Postprandial Proinsulin at Week 24
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Assessment method [9]
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Change was calculated for fasting proinsulin and 2-hour postprandial proinsulin by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of the study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.
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Timepoint [9]
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Baseline, Week 24
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Secondary outcome [10]
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Change From Baseline in Insulin Resistance Assessed by Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) at Week 24
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Assessment method [10]
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HOMA-IR was derived from FPG and FPI as: (FPI [micro units per milliliter]*FPG [mmol/L]) divided by 22.5. Change was calculated for HOMA-IR by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.
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Timepoint [10]
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Baseline, Week 24
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Secondary outcome [11]
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Change From Baseline in Beta Cell Function Assessed by Homeostasis Model Assessment-Beta (HOMA-beta) at Week 24
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Assessment method [11]
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HOMA-beta was derived from FPG and FPI as: (20*FPI [micro units/milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated for HOMA-beta by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.
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Timepoint [11]
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Baseline, Week 24
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Secondary outcome [12]
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Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24
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Assessment method [12]
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The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.
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Timepoint [12]
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Week 24
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Secondary outcome [13]
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Percentage of Patients Requiring Rescue Therapy During 24-Week Period
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Assessment method [13]
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Routine fasting self-measured plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%.
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Timepoint [13]
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Baseline up to Week 24
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Eligibility
Key inclusion criteria
Inclusion criteria
- Type 2 diabetes mellitus, diagnosed for at least 1 year at the time of screening
visit, insufficiently controlled with metformin at a stable dose of at least 1.5
gram/day (g/day) for at least 3 months prior to the screening visit
- Patients with obesity (BMI greater than equal to [>=] 30 kg/m^2) and aged from 18
years to less than 50 years
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Minimum age
18
Years
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Maximum age
49
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria
- HbA1c less than (<) 7.0 percent (%) or HbA1c greater than (>) 10% at screening
- Type 1 diabetes mellitus
- Pregnant or breastfeeding women or women of childbearing potential with no effective
contraceptive method
- FPG at screening >250 milligram/deciliter (mg/dL) (>13.9 millimole/ liter [mmol/L])
- Weight change of more than 5 kg during the 3 months preceding the screening visit
- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy,
stomach/gastric surgery, inflammatory bowel disease, personal or family history of
medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (for
example, multiple endocrine neoplasia syndromes)
- History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to
screening
- Hemoglobinopathy or hemolytic anemia or receipt of blood or plasma products within 3
months prior to the time of screening
- Within the last 6 months prior to screening: history of myocardial infarction, stroke,
or heart failure requiring hospitalization
- Known history of drug or alcohol abuse within 6 months prior to the time of screening
- Any clinically significant abnormality identified on physical examination, laboratory
tests, electrocardiogram (ECG) or vital signs at the time of screening that in the
judgment of the investigator or any sub-investigator could have precludes safe
completion of the study or constrains efficacy assessment such as major systemic
diseases, presence of clinically significant diabetic retinopathy or presence of
macular edema likely to require laser treatment within the study period
- Uncontrolled or inadequately controlled hypertension at the time of screening with a
resting systolic or diastolic blood pressure >180 millimeter of mercury (mmHg) or >110
mmHg, respectively
- Laboratory findings at the time of screening : Amylase and/or lipase >3 times the
upper limit of normal (ULN) laboratory range; alanine aminotransferase (ALT): >3 times
ULN; total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome);
hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3)
and/or platelets <100 000/mm^3; positive test for Hepatitis B surface antigen (HBsAg)
and/or Hepatitis C antibody (HCAb), positive serum pregnancy test in females of
childbearing potential, and calcitonin >=20 picogram per milliliter (pg/mL) (5.9
picomole per liter)
- Patients who are considered by the investigator or any sub-investigator as
inappropriate for the study for any reason (for example, impossibility to meet
specific protocol requirements [such as scheduled visits, being able to do
self-injections], likelihood of requiring treatment during the screening phase and
treatment phase with drugs not permitted by the clinical study protocol, investigator
or any sub-investigator, pharmacist, study coordinator, other study staff or relative
thereof directly involved in the conduct of the protocol)
- Use of other oral or injectable antidiabetic or hypoglycemic agents than metformin
(for example, sulfonylurea, alpha glucosidase inhibitor, thiazolidinedione, exenatide,
dipeptidyl peptidase IV (DPP-IV) inhibitors, insulin) within 3 months prior to the
time of screening
- History of bariatric surgery, anti-obesity treatment, or unstable diet within 3 months
prior to the time of screening
- Use of systemic glucocorticoids (excluding topical application or inhaled forms) for
one week or more within 3 months prior to the time of screening
- Use of any investigational drug within 3 months prior to screening
- Clinically relevant history of gastrointestinal disease associated with prolonged
nausea and vomiting, including (but not limited to): gastroparesis, unstable (that is,
worsening) and not controlled (that is, prolonged nausea and vomiting)
gastroesophageal reflux disease requiring medical treatment, within 6 months prior to
the time of screening
- Any previous treatment with lixisenatide (for example, participation in a previous
study with lixisenatide)
- Allergic reaction to any glucagon like peptide-1 (GLP 1) agonist in the past (for
example, exenatide, liraglutide) or to metacresol
- History of a serious hypersensitivity reaction to sitagliptin
- Moderate or severe renal impairment (creatinine clearance inferior to 50
milliliter/minute [mL/min])
- Additional exclusion criteria at the end of the run-in phase: informed consent
withdrawal; lack of compliance during the single-blind placebo run-in period (>2
injections missed or >2 capsules missed); and patient with any adverse event which
could have precludes the inclusion in the study, as assessed by the investigator
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2011
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Sample size
Target
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Accrual to date
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Final
319
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sanofi-Aventis Investigational Site Number 036006 - Adelaide
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Recruitment hospital [2]
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Sanofi-Aventis Investigational Site Number 036001 - Box Hill
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Recruitment hospital [3]
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Sanofi-Aventis Investigational Site Number 036004 - Elizabeth Vale
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Recruitment hospital [4]
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Sanofi-Aventis Investigational Site Number 036002 - Geelong
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Recruitment hospital [5]
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Sanofi-Aventis Investigational Site Number 036005 - Meadowbrook
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Recruitment hospital [6]
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Sanofi-Aventis Investigational Site Number 036003 - Sydney
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3128 - Box Hill
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Recruitment postcode(s) [3]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [4]
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3220 - Geelong
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Recruitment postcode(s) [5]
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4131 - Meadowbrook
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Recruitment postcode(s) [6]
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2006 - Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
0
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United States of America
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State/province [2]
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Arizona
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0
0
United States of America
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State/province [3]
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California
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Country [4]
0
0
United States of America
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State/province [4]
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Georgia
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Country [5]
0
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United States of America
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State/province [5]
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0
Illinois
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Country [6]
0
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United States of America
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State/province [6]
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Indiana
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Country [7]
0
0
United States of America
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State/province [7]
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Louisiana
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Country [8]
0
0
United States of America
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State/province [8]
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Michigan
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Country [9]
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United States of America
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State/province [9]
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Missouri
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Country [10]
0
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United States of America
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State/province [10]
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Montana
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Country [11]
0
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United States of America
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State/province [11]
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Ohio
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Country [12]
0
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United States of America
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State/province [12]
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Oregon
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Country [13]
0
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United States of America
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State/province [13]
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Pennsylvania
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United States of America
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State/province [14]
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Tennessee
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Country [15]
0
0
United States of America
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State/province [15]
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Texas
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Country [16]
0
0
Brazil
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State/province [16]
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Belem
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Country [17]
0
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Brazil
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State/province [17]
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Brasilia
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Country [18]
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Brazil
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State/province [18]
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Caxias Do Sul
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Brazil
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State/province [19]
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Curitiba
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0
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Brazil
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State/province [20]
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Rio De Janeiro
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Country [21]
0
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Brazil
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State/province [21]
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Sao Paulo
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Country [22]
0
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Canada
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State/province [22]
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Calgary
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Country [23]
0
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Canada
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State/province [23]
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Hamilton
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Country [24]
0
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Canada
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State/province [24]
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London
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0
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Canada
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State/province [25]
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Montreal
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0
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Canada
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State/province [26]
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Oakville
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0
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Canada
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State/province [27]
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0
St-Romuald
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0
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Canada
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State/province [28]
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Thornhill
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0
0
Canada
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State/province [29]
0
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Toronto
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0
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Canada
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Vancouver
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0
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Canada
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State/province [31]
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Victoria
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Country [32]
0
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Chile
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State/province [32]
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Santiago
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0
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Germany
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State/province [33]
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Berlin
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Country [34]
0
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Germany
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State/province [34]
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Ludwigshafen
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0
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Germany
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State/province [35]
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Schkeuditz
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Country [36]
0
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Guatemala
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Guatemala
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Country [37]
0
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Mexico
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State/province [37]
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Aguascalientes
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0
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Mexico
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State/province [38]
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Chihuahua
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Country [39]
0
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Mexico
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State/province [39]
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Df
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Country [40]
0
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Mexico
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State/province [40]
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Merida
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Country [41]
0
0
Mexico
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State/province [41]
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México City
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0
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Mexico
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State/province [42]
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Pachuca
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0
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Mexico
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Veracruz
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0
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Mexico
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State/province [44]
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Zapopan
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0
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Peru
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State/province [45]
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Lima
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Country [46]
0
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Poland
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State/province [46]
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Bialystok
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Country [47]
0
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Poland
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State/province [47]
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Bydgoszcz
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Country [48]
0
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Poland
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State/province [48]
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Warszawa
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0
0
Poland
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State/province [49]
0
0
Wroclaw
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Country [50]
0
0
Romania
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State/province [50]
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Bacau
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0
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Romania
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State/province [51]
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0
Bucuresti
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0
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Romania
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State/province [52]
0
0
Iasi
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Country [53]
0
0
Romania
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State/province [53]
0
0
Ploiesti
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Country [54]
0
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Romania
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State/province [54]
0
0
Resita
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Country [55]
0
0
Romania
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State/province [55]
0
0
Suceava
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Country [56]
0
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Romania
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State/province [56]
0
0
Timisoara
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Country [57]
0
0
Russian Federation
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State/province [57]
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0
Kazan
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Country [58]
0
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Russian Federation
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State/province [58]
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0
St-Petersburg
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Country [59]
0
0
Russian Federation
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State/province [59]
0
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St. Petersburg
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Country [60]
0
0
Russian Federation
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State/province [60]
0
0
Tyumen
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Country [61]
0
0
Ukraine
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State/province [61]
0
0
Chernivtsi
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Country [62]
0
0
Ukraine
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State/province [62]
0
0
Kiev
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Country [63]
0
0
Ukraine
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Kyiv
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Funding & Sponsors
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Commercial sector/Industry
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Sanofi
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Summary
Brief summary
The purpose of this study is to evaluate benefits and risks of lixisenatide (AVE0010), in
comparison to sitagliptin, as an add-on treatment to metformin, in obese (body mass index
[BMI] greater than or equal to 30 kilogram per square meter [kg/m^2]) type 2 diabetic
patients less than 50 years of age, over a period of 24 weeks of treatment.
The primary objective of this study is to assess the efficacy of lixisenatide, in comparison
to sitagliptin, as an add-on treatment to metformin on a composite endpoint of glycemic
control in terms of glycosylated hemoglobin (HbA1c) and body weight, at Week 24.
Secondary objectives are to assess the effects of lixisenatide, in comparison to sitagliptin,
as an add-on treatment to metformin on absolute changes in HbA1c values and body weight;
fasting plasma glucose (FPG); plasma glucose, insulin, C-peptide, glucagon, and proinsulin
during a 2-hour standardized meal test; insulin resistance assessed by homeostatic model
assessment of insulin resistance (HOMA-IR); beta cell function assessed by homeostatic model
assessment of beta-cell function (HOMA-beta); to evaluate safety, tolerability, and
anti-lixisenatide antibody development.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00976937
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Sanofi
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00976937
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