Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus

NCT00530309 | Completed Phase 1

• 1 other identifier: GLP107865
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations and PD parameters over time and at the end of study

  Up to Week 9

Secondary Outcomes (1)

• Other metabolic parameters at the end of study

  Up to Week 9

Study Arms (1)

Subjects receiving GSK716155 + placebo

EXPERIMENTAL

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; Drug: Placebo

Interventions

GSK716155 for injection DRUG

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.

Subjects receiving GSK716155 + placebo

Placebo DRUG

Subjects will also receive placebo.

Subjects receiving GSK716155 + placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Fukuoka, 812-0025, Japan

Location

GSK Investigational Site

Tokyo, 130-0004, Japan

Location

GSK Investigational Site

Tokyo, 160-0017, Japan

Location

Related Publications (2)

• Seino Y, Nakajima H, Miyahara H, Kurita T, Bush MA, Yang F, Stewart MW. Safety, tolerability, pharmacokinetics and pharmacodynamics of albiglutide, a long-acting GLP-1-receptor agonist, in Japanese subjects with type 2 diabetes mellitus. Curr Med Res Opin. 2009 Dec;25(12):3049-57. doi: 10.1185/03007990903372999.

  PMID: 19863477 BACKGROUND

• Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.

  PMID: 25387217 DERIVED

Related Links

• Results for study GLP107865 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Injections

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2007
• First Posted: September 17, 2007
• Study Start: August 1, 2007
• Primary Completion: April 17, 2008
• Study Completion: April 17, 2008
• Last Updated: August 17, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (3)