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A Double-blind [Sponsor Unblinded], Randomized, Placebo-controlled, Staggered-parallel Study to Investigate the Safety, Tolerability, and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes
This study is the first administration of GSK2890457 in humans. The study will be conducted in 3 parts: - Part A (conducted at a single investigative site) will determine the safety and tolerability of GSK2890457 alone in healthy subjects during six weeks of dosing, as well as evaluating the potential for a pharmacokinetic interaction with metformin. Part A consists of Screening, Treatment (6 weeks) and Follow-up periods. - Part B (conducted at multiple sites) will determine safety, tolerability, and pharmacodynamics (PD) in subjects with Type 2 diabetes (T2D) when co-dosed for six weeks with liraglutide (Victoza). Part B consists of Screening, Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up periods. - Part C (conducted at multiple sites) will determine safety, tolerability, and PD in subjects with T2D when co-dosed for 6 weeks with metformin. Part C consists of Screening, Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up periods.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
Yes
GSK Investigational Site
Chula Vista, California, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Overland Park, Kansas, United States
Start Date
February 10, 2013
Primary Completion Date
September 12, 2013
Completion Date
September 12, 2013
Last Updated
December 13, 2017
53
ACTUAL participants
GSK2890457
DRUG
Metformin
DRUG
Placebo
DRUG
Liraglutide
DRUG
Lead Sponsor
GlaxoSmithKline
NCT07472881
NCT01143454
Data Source & Attribution
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