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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/NCT01029886
Registration number
NCT01029886
Ethics application status
Date submitted
8/12/2009
Date registered
10/12/2009
Date last updated
9/04/2015
Titles & IDs
Public title
Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes
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Scientific title
Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes and Inadequate Glycemic Control Treated With Lifestyle Modification and Oral Antidiabetic Medications
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Secondary ID [1]
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H8O-MC-GWDE
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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 - exenatide once weekly
Treatment: Drugs - liraglutide
Experimental: 1 -
Active Comparator: 2 -
Treatment: Drugs: exenatide once weekly
subcutaneous injection, 2mg, once weekly
Treatment: Drugs: liraglutide
subcutaneous injection, forced titration to 1.8mg, once daily
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Intervention code [1]
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Treatment: Drugs
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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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Change in HbA1c From Baseline to Week 26
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Assessment method [1]
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Change in HbA1c from baseline to the treatment endpoint at Week 26.
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Timepoint [1]
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Baseline, Week 26
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Secondary outcome [1]
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Percentage of Patients Achieving HbA1c <7.0% at Week 26
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Assessment method [1]
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Percentage of patients achieving HbA1c <7.0% at treatment endpoint at Week 26.
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Timepoint [1]
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Baseline, Week 26
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Secondary outcome [2]
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Change in Fasting Serum Glucose From Baseline to Week 26
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Assessment method [2]
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Change in fasting serum glucose from baseline to the treatment endpoint at Week 26.
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Timepoint [2]
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Baseline, Week 26
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Secondary outcome [3]
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Change in Body Weight From Baseline to Week 26
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Assessment method [3]
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Change in body weight from baseline to the treatment endpoint at Week 26.
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Timepoint [3]
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Baseline, Week 26
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Secondary outcome [4]
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Change in Total Cholesterol From Baseline to Week 26
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Assessment method [4]
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Change in total cholesterol from baseline to the treatment endpoint at Week 26.
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Timepoint [4]
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Baseline, Week 26
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Secondary outcome [5]
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Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
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Assessment method [5]
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Change in HDL-C from baseline to the treatment endpoint at Week 26.
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Timepoint [5]
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Baseline, Week 26
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Secondary outcome [6]
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Ratio of Fasting Triglycerides at Week 26 to Baseline
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Assessment method [6]
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Ratio of fasting triglycerides (measured in mmol/L) treatment endpoint at Week 26 to baseline. Log(Postbaseline fasting triglycerides) - log(Baseline fasting triglycerides); change from baseline to the treatment endpoint at Week 26 is presented as ratio of Week 26 to baseline.
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Timepoint [6]
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Baseline, Week 26
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Secondary outcome [7]
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Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
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Assessment method [7]
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Change in SBP from baseline to the treatment endpoint at Week 26.
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Timepoint [7]
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Baseline, Week 26
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Secondary outcome [8]
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Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26
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Assessment method [8]
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Change in DBP from baseline to the treatment endpoint at Week 26.
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Timepoint [8]
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Baseline, Week 26
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Secondary outcome [9]
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Assessment of Event Rate of Treatment-emergent Hypoglycemic Events
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Assessment method [9]
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Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.
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Timepoint [9]
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Baseline to Week 26
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Eligibility
Key inclusion criteria
- Diagnosed with type 2 diabetes
- Have suboptimal glycemic control as evidenced by an HbA1c measurement at study start
7.1% and 11.0%, inclusive
- Have a body mass index (BMI) =45 kg/m^2
- Have been treated with lifestyle modification (diet and exercise) and with one of the
following single oral antidiabetic agents (OADs) or combinations of OADs administered
at maximum tolerated dose:
- metformin
- SU
- metformin plus an SU
- metformin plus pioglitazone
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Minimum age
18
Years
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Maximum age
No limit
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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
- Have any contraindication, allergy, or hypersensitivity for the study drug (exenatide
once weekly or liraglutide), exenatide twice daily, the OAD(s) being used, or the
excipients contained in these agents
- If taking metformin and have a contraindication to metformin use
- Have been treated within 8 weeks of study start with systemic glucocorticoid therapy
by oral, intravenous, intra-articular, or intramuscular route
- Have been treated with drugs that promote weight loss (e.g., Xenical® [orlistat],
Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or
similar over-the-counter medications) within 3 months of study start
- Have taken any of the following excluded medications for more than 1 week within the 3
months prior to study start, or have taken any of the following excluded medications
within 1 month prior to study start:
- Insulin
- Alpha-glucosidase inhibitors (e.g., Glyser® [miglitol] or Precose® [acarbose])
- Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide])
- Avandia® (rosiglitazone)
- Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januviaâ„¢ [sitagliptin], Galvus®
[vildagliptin], Onglyzaâ„¢ [saxagliptin])
- Symlin® (pramlintide acetate)
- Have donated blood within 30 days prior to study start or have had a blood transfusion
or severe blood loss within 3 months prior to study start
- Have at any time, including a clinical trial, taken exenatide once weekly, exenatide
twice daily, liraglutide, or any other GLP-1 receptor agonist or GLP-1 analog
- Are currently enrolled in, or discontinued within the last 3 months or longer if
required by local guidelines, from a clinical trial involving use of an
investigational drug or device, or concurrently enrolled in any other type of medical
research judged not to be scientifically or medically compatible with this study
- Have previously been screen-failed from this study for any reason
- If a subject discontinues metformin, sulfonylurea, or pioglitazone prior to screening,
the subject can be included if they discontinued the medication (whether alone or as
component of combined medication) according to a specific schedule.
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
1/01/2010
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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
1/04/2011
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Sample size
Target
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Accrual to date
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Final
912
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Box Hill
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Research Site - Geelong
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Recruitment hospital [3]
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Research Site - Keswick
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- Box Hill
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Recruitment postcode(s) [2]
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- Geelong
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Recruitment postcode(s) [3]
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- Keswick
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Recruitment outside Australia
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Argentina
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Buenos Aires
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India
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India
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Italy
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Chieti
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Italy
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Treviglio
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Seoul
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Mexico
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Mexico
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Romania
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Bucuresti
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Bratislava
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Martin
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Halfway House
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Johannesburg
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South Africa
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Kempton Park
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South Africa
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Parktown
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South Africa
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Pretoria
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Alcira
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Alicante
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Madrid
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Teruel
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Taiwan
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Changhua
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Sindian
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Taichung
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Taiwan
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Yung-Kang, Tainan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Eli Lilly and Company
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
No head to head comparisons between exenatide once weekly and liraglutide have been
performed. Therefore, the purpose of this study is to compare exenatide once weekly to
once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and
other clinical benefits. The study includes a 26-week treatment period and a safety follow-up
visit 10 weeks after the final study drug dose.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01029886
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Chief Medical Officer, MD
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Address
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Eli Lilly and Company
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0
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Phone
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01029886
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