Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2008-04-17
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion criteria:

• Type 2 diabetes mellitus diagnosed at least 3 months with FPG level <=240mg/dL and HbA1c between 6.5% and 10% inclusive.

• Must be diet controlled - OR - taking a single oral antidiabetic agent (other than thiazolidinediones) and willing to withdraw from this treatment from 2 weeks prior to the study.

• Must have a BMI:<=35kg/m2, 20 to 70 years of age inclusive.

• Woman must be of non-childbearing potential.

Exclusion criteria:

• Positive test result for either syphilis, HBs antigen, HCV antibody, HIV antigen/antibody, or HTLV-1 antibody.

• Clinically significant hepatic enzyme elevation.

• History of metabolic disease other than T2DM.

• Previous use of insulin as a treatment for diabetes within 3 months.

• History of severe gastrointestinal disease.

• Clinically significant cardiovascular disease.

• Significant renal disease as defined by screening lab test.

• History of drug (including albumin or albumin containing agents) allergy.

• History of alcohol or drug abuse.

• Donation of blood in excess of 400mL within previous 4 months.

• Previously received any GLP-1 mimetic or any other albumin-containing products.