Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus

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

Official Title
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Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus -A Phase I/II Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of GSK716155 in Japanese Subjects With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: GSK716155 for injection
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects receiving GSK716155 + placebo<br>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. | Drug: GSK716155 for injection<br>* GSK716155 will be available with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks.<br>Drug: Placebo<br>* Subjects will also receive placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations and PD parameters over time and at the end of study |  | Up to Week 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other metabolic parameters at the end of study |  | Up to Week 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GLP-1, type 2 diabeted mellitus, safety, GSK716155, GLP-1 receptor agonist, tolerability, pharmacokinetics, pharmacodynamics