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

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Accepted

Interventions

• 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 — 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

Study Details

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.

Key Dates

Start date

Feb 10, 2013

Status verified

Nov 2017

Primary completion

Sep 12, 2013

Completion

Sep 12, 2013

Study Design

Enrollment

53 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A - GSK2890457
  Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks
• Experimental: Part B - GSK2890457 + Liraglutide
  Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks
• Experimental: Part C - GSK2890457 + Metformin
  Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks
• Placebo Comparator: Part A - Placebo
  Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks
• Placebo Comparator: Part B - Placebo
  Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks
• Placebo Comparator: Part C - Placebo
  Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks

Primary Outcome Measure

Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE) or Death During Part A [ Time Frame: Up to Follow-up (8 weeks) ]

Locations (3)

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