Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00530309

Enrollment

Registered

2007-09-17

Start date

2007-08-01

Completion date

2008-04-17

Last updated

2017-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

GLP-1, type 2 diabeted mellitus, safety, GSK716155, GLP-1 receptor agonist, tolerability, pharmacokinetics, pharmacodynamics

Brief summary

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

Interventions

DRUGGSK716155 for injection

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.

DRUGPlacebo

Subjects will also receive placebo.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Other metabolic parameters at the end of study	Up to Week 9

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026