To Investigate the Safety, Tolerability and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes

What this study is testing ClinicalTrials.gov NCT01725126 ↗

Description as written by the study sponsor.

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.

Treatments tested

• GSK2890457 Drug

  Provided as powder and capsule.

• Metformin Drug

  Tablet Part A: Single doses on Day 1 and Day 42 orally Part B: Subject continues usual metformin dose through Run-in, and resumes after Treatment Period completed Part C: Subject continues usual metformin dose throughout study

• Placebo Drug

  Provided as powder and Capsule.

• Liraglutide also known as Victoza Drug

  Provided as Injection. 6mg/mL, 3mL injector pen that permits doses of 0.6mg, 1.2mg, and 1.8mg Subcutaneous injection 18 weeks dosing (Stabilization and Treatment Periods, Part B only