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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00196989 |
This Phase 2 dose-ranging study will evaluate the efficacy, safety and tolerability of a range of doses of GW677954 compared with placebo over sixteen weeks of treatment in subjects with T2DM (Type 2 Diabetes Mellitus).
Condition | Intervention | Phase |
---|---|---|
Non-Insulin-Dependent Diabetes Mellitus |
Drug: Pioglitazone Drug: GW677954 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | See Detailed Description |
Enrollment: | 448 |
Study Start Date: | September 2005 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Study To Evaluate Efficacy, Safety And Tolerability Of Oral GW677954 Capsules (2.5, 5, 10, 15 And 20 Mg Once A Day) As A Monotherapy (Diet and/or exercise treated) Or As An Add-On To Metformin For 16 Weeks Duration In Subjects With Type 2 Diabetes Mellitus
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
To be eligible for Randomization into the trial, a subject must satisfy all of the following glycemic criteria:
Concurrent T2DM therapy:
If female, eligible to enter and participate in this study:
If of child-bearing potential, has a negative pregnancy test at Screening (serum), at Randomization (urine) and:
Exclusion criteria:
Exclusion Criteria:
Metabolic Disease including:
History of recent clinically significant cardiovascular disease including:
Documented history of hepato-biliary disease including a history of, or positive laboratory results for hepatitis (hepatitis B surface antigen and/or hepatitis C antibody) at Screening, and/or clinically significant hepatic enzyme elevation including:
Any one of the following enzymes greater than 2.5 times the upper limit of normal (ULN) value at Screening:
Is currently taking or has taken any of the following medications in the 3 months prior to the pre-screening visit:
History of cancer except for the following:
Has a history of substance and/or alcohol abuse within the past year as determined by the Investigator at screening or during treatment:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | ADG20001 |
Study First Received: | September 13, 2005 |
Last Updated: | May 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00196989 History of Changes |
Health Authority: | United States: Food and Drug Administration |
GW677954 Phase IIb PPARpan Type 2 Diabetes Mellitus Dose-Ranging |
Pharmacokinetics Pharmacodynamics Safety Efficacy Tolerability |
Hypoglycemic Agents Metabolic Diseases Pioglitazone Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Hypoglycemic Agents Metabolic Diseases Pioglitazone Physiological Effects of Drugs Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |