Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: GSK716155 for injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00530309

GLP107865

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 1 patient group

Subjects receiving GSK716155 + placebo

Experimental group

Description:

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.

Treatment:

Drug: GSK716155 for injection

Drug: Placebo