Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: GSK716155 for injection; Drug: Placebo

• Registration Number: NCT00530309
• Lead Sponsor: GlaxoSmithKline

Brief Summary

A Phase I/II study to investigate the safety, pharmacokinetics and pharmacodynamics of GSK716155 in Japanese subjects with type 2 diabetes mellitus

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-01
• Study First Submitted: 2007-09-14
• Study First Submitted QC: 2007-09-14
• Study First Posted: 2007-09-17
• Primary Completion: 2008-04-17
• Study Completion: 2008-04-17
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects receiving GSK716155 + placebo	GSK716155 for injection	Eligible subjects will receive GSK716155 with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks. Subjects will also receive placebo.
Subjects receiving GSK716155 + placebo	Placebo	Eligible subjects will receive GSK716155 with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks. Subjects will also receive placebo.

Primary Outcome Measures

Name	Time	Method
Plasma concentrations and PD parameters over time and at the end of study	Up to Week 9

Secondary Outcome Measures

Name	Time	Method
Other metabolic parameters at the end of study	Up to Week 9

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Tokyo, Japan