NCT00354536CompletedPhase 2
A Single-blinded Randomized, Placebo-controlled, Staggered-parallel, Escalating-dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Injections of GSK 716155 in Subjects With Type 2 Diabetes Mellitus
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- blood plasma levels of GSK716155
Study Overview
Brief Summary
This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is given at the same dose 7 days apart, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
albiglutide
Active Comparator
albiglutide injection
Intervention: GSK716155 subcutaneous injections (Drug)
albiglutide placebo
Placebo Comparator
placebo injection
Intervention: placebo injection (Biological)
Outcomes
Primary Outcomes
blood plasma levels of GSK716155
Time Frame: on days 2 & 9
Secondary Outcomes
- blood plasma levels of GSK716155(on days 2 & 9)
Investigators
Study Sites (1)
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