Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530309
• Other study ID #: GLP107865
• Status: Completed
• Phase: Phase 1
• First received: September 14, 2007
• Last updated: August 15, 2017
• Start date: August 1, 2007
• Est. completion date: April 17, 2008

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 17, 2008
• Est. primary completion date: April 17, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• GSK716155 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.
• Placebo
Subjects will also receive placebo.

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations and PD parameters over time and at the end of study		Up to Week 9
Secondary	Other metabolic parameters at the end of study		Up to Week 9

External Links

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