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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/NCT00495469
Registration number
NCT00495469
Ethics application status
Date submitted
29/06/2007
Date registered
3/07/2007
Date last updated
30/10/2017
Titles & IDs
Public title
Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive
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Scientific title
A Once-Daily Dose-Ranging Study of GSK189075 Versus Placebo In The Treatment of Type 2 Diabetes Mellitus in Treatment-Naïve Subjects
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Secondary ID [1]
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KG2110375
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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:
Diabetes Mellitus, Type 2
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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 - GSK189075
Treatment: Drugs - Placebo
Experimental: GSK189075 - Participants will receive GSK189075 for 12 weeks
Placebo Comparator: Placebo - Participants will receive GSK189075 matching Placebo for 12 weeks
Treatment: Drugs: GSK189075
GSK189075 is available as a white, capsule-shaped tablet dosage form containing 50mg, 125mg, 250mg or 500mg of GSK189075 per tablet
Treatment: Drugs: Placebo
Available as Placebo matching tablet to GSK189075
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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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Mean Change From Baseline in Hemoglobin A1c (Glycosylated Hemoglobin) (HbA1c) at Week 12
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Assessment method [1]
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The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the Intent-to-Treat (ITT) Population with Last observation carried forward (LOCF). Adjusted mean is presented as least square (LS) mean.
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Timepoint [1]
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Baseline (Week 0) and at Week 12
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Secondary outcome [1]
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Mean Change From Baseline in HbA1c at Weeks 4 and 8
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Assessment method [1]
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The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 4 and 8 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF.
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Timepoint [1]
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Baseline (Week 0) and at Week 4 nad 8
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Secondary outcome [2]
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Mean Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)
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Assessment method [2]
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The samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean.
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Timepoint [2]
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Baseline (Week 0) and at Week 12
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Secondary outcome [3]
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Mean Change From Baseline to Week 12 in Fructosamine (Corrected)
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Assessment method [3]
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The blood samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean.
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Timepoint [3]
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Baseline (Week 0) and at Week 12
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Secondary outcome [4]
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Number of Participants Who Were HbA1c Responders at Week 12
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Assessment method [4]
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Differences between treatment groups in the proportion of participants who achieved HbA1c targets of <=6.5% and <7% at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline HbA1c. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in HbA1c (>=0.7%) at Week 12 were assessed in the same manner.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Number of Participants Who Were Fasting Plasma Glucose (FPG) Responders at Week 12
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Assessment method [5]
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Differences between treatment groups in the proportion of participants who achieved FPG targets of <7.0 millimoles per liter (mmol/L) (126 milligrams per deciliter [mg/dL]) and <7.8 mmol/L (140 mg/dL) at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline FPG. The proportion of participants who achieved the target of <5.5 mmol/L (100 mg/dL) at Week 12 within each treatment group were summarized only. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in FPG (1.7 mmol/L [>=30 mg/dL]) at Week 12 were assessed in the same manner.
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Mean Change From Baseline to Week 12 in Triglycerides
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Assessment method [6]
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Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.
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Timepoint [6]
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Baseline (Week 0) and at Week 12
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Secondary outcome [7]
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Mean Change From Baseline to Week 12 in Total Cholesterol
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Assessment method [7]
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Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.
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Timepoint [7]
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Baseline (Week 0) and at Week 12
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Secondary outcome [8]
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Mean Change From Baseline to Week 12 in Low Density Lipoprotein Cholesterol (LDL-c)
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Assessment method [8]
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Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.
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Timepoint [8]
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Baseline (Week 0) and Week 12
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Secondary outcome [9]
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Mean Change From Baseline to Week 12 in High Density Lipoprotein Cholesterol (HDL-c)
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Assessment method [9]
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Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.
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Timepoint [9]
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Baseline (Week 0) and Week 12
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Secondary outcome [10]
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Mean Change From Baseline to Week 12 in LDL-c/HDL-c Ratio
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Assessment method [10]
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Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.
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Timepoint [10]
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Baseline (Week 0) and Week 12
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Secondary outcome [11]
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Mean Change From Baseline to Week 12 in Total Cholesterol/HDL-c Ratio
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Assessment method [11]
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Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.
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Timepoint [11]
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Baseline (Week 0) and Week 12
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Secondary outcome [12]
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Mean Change From Baseline to Week 12 in Body Weight
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Assessment method [12]
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Body weight measurement was taken at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.
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Timepoint [12]
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Baseline (Week 0) and Week 12
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Secondary outcome [13]
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Number of Participants With Any On-therapy Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [13]
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AE was defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
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Timepoint [13]
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Up to Week 12
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Secondary outcome [14]
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Number of Participants With On-therapy Hypoglycemia
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Assessment method [14]
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Participants were provided with a Daily Glucose Monitoring Log to record glucose meter readings and to record symptoms of hypoglycemia. A separate electronic case report form (eCRF) page was provided to capture events of hypoglycemia.
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Timepoint [14]
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Up to Week 12
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Secondary outcome [15]
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Number of Participants With Vital Signs of Potential Clinical Importance (PCI) at Any Time on Therapy
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Assessment method [15]
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Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) were measured pre-dose in duplicate, after the participant has been lying quietly for 5 minutes, and then in duplicate 3 minutes after standing up. Participants were asked to refrain from smoking for at least 30 minutes prior to vital sign measurements.
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Timepoint [15]
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Up to Week 12
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Secondary outcome [16]
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Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline
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Assessment method [16]
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Full 12-lead ECGs were recorded at Randomization (Week 0), Week 4, and Week 12 or early withdrawal. If the QTc was >500 milliseconds on the locally read ECG recording, an additional 2 ECG recordings at 10 minute intervals were made at that visit. If the average QTc for the 3 recordings was >500 milliseconds, the participant was withdrawn from the study.
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Timepoint [16]
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Up to Week 12
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Secondary outcome [17]
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Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy
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Assessment method [17]
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Chemistry parameters: Albumin, Alkaline phosphatase, Alanine animotransferase, Aspartate aminotransferase, Total billirubin, Calcium, Carbon dioxide/Bicarbonate, Glucose, Potassium, Sodium, Phosphorus and Total protein were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up).
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Timepoint [17]
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Up to Week 12
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Secondary outcome [18]
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Number of Participants With Abnormal Hematology Value of PCI at Any Time on Therapy
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Assessment method [18]
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Hematology parameters: Hemoglobin, Hematocrit, Platelet count and White blood cells were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up).
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Timepoint [18]
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Up to Week 12
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Eligibility
Key inclusion criteria
- Subjects with a documented diagnosis of T2DM and HbA1c =7.0% and =9.5% measured by the
central laboratory at Visit 1.
- Note: Subjects with HbA1c <7.5% must have a fasting fingerstick glucose =7 mmol/L
(126 mg/dL) at Week 0, prior to randomization.
- Note: The proportion of subjects who are randomized with an HbA1c <7.5% will be
limited to be no more than 20% (approximately 51 subjects)
- Subjects who are treatment-naïve, and have not taken insulin, or any oral or
injectable anti-diabetic medication in the past 3 months and have not taken a glucose
lowering agent for =4 weeks at any time in the past, or subjects who are newly
diagnosed and treated with diet and exercise for a minimum of 6 weeks
- Subjects who are 18 to 70 years of age inclusive at the time of Screening.
- Females of childbearing and non-childbearing and potential are eligible to participate
as follows:
- Women of childbearing potential must be willing to use one of the following
contraception methods: intrauterine device, condom or occlusive cap (diaphragm or
cervical/vault caps) plus spermicidal agent for at least 30 days prior to the
start of study medication, throughout the study and the follow-up visit. Note:
use of oral contraceptives is not permitted.
- Women of non-child bearing potential are defined as follows: females regardless
of age, with functioning ovaries who have a current documented tubal ligation, or
who are surgically sterile (i.e. documented total hysterectomy or bilateral
oophorectomy), or females who are post-menopausal.
All females must have a negative urine pregnancy test on the day of, and prior to
randomization.
- Informed Consent: a signed and dated written consent must be obtained from the subject
before any procedures are performed.
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Minimum age
18
Years
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Maximum age
70
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
- Metabolic Disease
- Diagnosis of Type 1 diabetes mellitus
- History of ketoacidosis which has required hospitalization
- Thyroid disorder
- TSH <0.4 MIU/L (<0.4 MCIU/mL) or >5.5 mIU/L (>5.5 MCIU/mL) at Screening
- BMI of <22 kg/m2 or >43 kg/m2
- Significant weight gain or loss (as defined as >5% of total body weight) in the 3
months prior to Screening
- Diabetic Medication
- Has taken insulin, or any oral or injectable anti-diabetic medication within 3
months of screening
- Has taken insulin or any oral or injectable anti-diabetic medication =4 weeks at
any time in the past
- Cardiovascular Disease
Recent history or presence of clinically significant acute cardiovascular disease
including:
- Documented myocardial infarction in the 6 months prior to Screening.
- Coronary revascularization including percutaneous transluminal coronary angioplasty
(PTCA) or coronary artery bypass graft (CABG) surgery either planned and/or occurred
in the 6 months prior to Screening.
- Unstable angina in the 6 months prior to Screening.
- Clinically significant supraventricular arrhythmias requiring medical therapy, or
history of nonsustained or sustained ventricular tachycardia. Symptomatic valvular
heart disease or valvular heart disease requiring therapy other than endocarditis
prophylaxis.
- Congestive heart failure (CHF, New York Heart Association (NYHA) Class II to IV)
requiring pharmacologic treatment or the NYHA Class criteria in accordance with the
local prescribing information for pioglitazone.
- Blood pressure (BP) >150/100mmHg. If a subject is receiving permitted antihypertensive
therapy, then they must be on stable dose(s) of therapy for at least 4 weeks prior to
Screening.
- Based on local readings, the subject has an initial QTc interval (Bazett's)=450msec at
Screening, and after two additional ECGs taken 5 minutes apart, the average of the QTC
interval from the three ECGs is =450msec.
- Other clinically significant ECG abnormalities which, in the opinion of the
Investigator, may affect the interpretation of efficacy or safety data, or which
otherwise contraindicates participation in a clinical trial with a new chemical
entity.
- Fasting triglycerides =400mg/dL (4.56mmol/L) at Screening. If a subject is receiving
permitted lipid-lowering therapy, then they must be on a stable dose(s) of therapy for
at least 6 weeks prior to Screening. Niacin and bile acid sequestrants are prohibited.
- Hepatic Disease
Has a diagnosis of active hepatitis (hepatitis B surface antigen or hepatitis C antibody),
or clinically significant hepatic enzyme elevation including:
Any one of the following enzymes greater than 2 times the upper limit of the reference
range (ULRR) value at Screening.
- alanine aminotransferase (ALT)
- aspartate aminotransferase (AST)
- alkaline phosphatase (AP) Has a total bilirubin level that is >1.5 times the ULRR at
Screening with the exception of suspected or confirmed Gilbert's disease.
- Pancreatic Disease
- Secondary causes of diabetes:
- history of chronic or acute pancreatitis
- Renal Disease
Significant renal disease at Screening as manifested by:
- Glomerular filtration rate (GFR) <60mL/min (as calculated by Quest at Visit using the
Modification of Diet in Renal Disease (MDRD) equation
•=1+ protein on urine dipstick
- Trace or =1+ leukocyte esterase on urine dipstick
- Trace or =1+ blood on urine dipstick
- Positive nitrite on urine dipstick
- Recurrent genitourinary tract infections defined as =2 episodes of complicated or
uncomplicated cystitis or pyelonephritis in the 6 months prior to Screening.
- Concurrent Disease
- Has any concurrent condition or any clinically significant abnormality identified on
the screening physical examination, laboratory tests (including blood electrolytes),
ECG, including pulmonary, neurological or inflammatory diseases, which, in the opinion
of the investigator, may affect the interpretation of efficacy and safety data, or
which otherwise contraindicates participation in a clinical trial with a new chemical
entity.
- History of significant co-morbid diseases active in the 6 months prior to Screening
(e.g., cholecystitis, acute pancreatitis, gastrointestinal disease, chronic diarrhea,
etc.).
- History of malignancy within the past 5 years other than superficial squamous cell
carcinoma (non-invasive on pathology) or basal cell carcinoma (successfully treated
with local excision).
- History of cervical cancer in situ treated definitively at least 6 months prior to
Screening.
- Concurrent Medication
Is currently taking or has taken any of the following medications in the 8 weeks prior to
Screening:
- Digoxin
- Warfarin and other oral anticoagulants (aspirin and non-steroidal anti-inflammatory
drugs are permitted)
- Bile acid sequestrants
- Niacin (excluding routine vitamin supplementation)
- Antiobesity agents (including fat absorption blocking agents)
- Oral or injectable corticosteroids (inhaled, topical and intranasal corticosteroids
are permitted)
- Loop diuretics
- Monoamine oxidase inhibitors and tricyclic amines
- Antiretroviral drugs
- St John's Wort
- Oral chromium 9.Breast Feeding 10.Other
- Current smoker who is unable to abstain from smoking while in the clinic at each visit
- Has a history of alcohol or substance abuse within the past year at Screening or
alcohol or substance abuse during treatment, as determined by the investigator:
- Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated
restrictions while participating in the study
- Has an average weekly intake of alcohol of >21 units or an average daily intake of >3
units (males) or an average weekly intake of >14 units or an average daily intake of
>2 units (females). One unit is equivalent to a half pint of beer or 1 measure of
spirits or 1 glass of wine
- Has participated in any study with an investigational or marketed drug in the 3 months
prior to Screening.
- In the opinion of the investigator has a risk of non-compliance with study procedures,
or cannot read, understand, or complete study related materials, particularly the
informed consent.
- Known allergy to any of the tablet or capsule excipients, or history of drug or other
allergy, which, in the opinion of the responsible study physician, contraindicates
participation.
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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 2
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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
17/08/2007
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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
5/06/2008
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Sample size
Target
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Accrual to date
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Final
250
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Georgia
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Illinois
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Indiana
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Louisiana
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Maryland
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Massachusetts
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Mississippi
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Missouri
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Nevada
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New Mexico
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Washington
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British Columbia
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Canada
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New Brunswick
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Canada
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Newfoundland and Labrador
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0
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Québec
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Czechia
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Brno
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Czechia
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Praha 10
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Czechia
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Praha 5
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Estonia
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Parnu
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Tallinn
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Estonia
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Tallin
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Estonia
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Tartu
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Romania
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Russian Federation
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Ukraine
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Funding & Sponsors
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Commercial sector/Industry
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GlaxoSmithKline
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Summary
Brief summary
This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of
doses of GSK189075 (an SGLT2 inhibitor) compared to placebo, administered over 12 weeks in
treatment-naive subjects with type 2 diabetes mellitus
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00495469
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Contacts
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GSK Clinical Trials
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GlaxoSmithKline
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00495469
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