In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Single-blinded Randomized, Placebo-controlled, Staggered-parallel, Escalating-dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Injections of GSK 716155 in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354536
• Other study ID #: GLP106073
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2006
• Last updated: October 24, 2016
• Start date: February 2006
• Est. completion date: September 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is given at the same dose 7 days apart, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

• Subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months.

• Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea.

• Subjects must be willing to wash-out of these medications for 14 days prior to the start of the study.

• Subjects must have a BMII between 25 and 40 kg/m² and weigh at leas 50kg.

• Women must be of non-childbearing potential.

Exclusion criteria:

• Laboratory values that meet certain criteria (for example, total cholesterol > 240 mg/dL).

• Clinically significant hepatic enzyme elevation.

• Fasting plasma glucose greater than 240mg/dL.

• Positive test result for Hepatitis B surface antigen, positive Hepatitis C or HIV.

• Any major illness other than diabetes.

• Previous use of insulin as treatment for diabetes.

• Significant renal disease as defined by screening lab tests.

• History of drug or other allergy, which in the opinion of the investigator contradicts subject participation.

• Smoking or use of nicotine-containing products within the previous 6 months.

• History of alcohol or drug abuse.

• Unwilling to abstain from alcohol during the study.

• Unwilling to abstain from caffeine- or xanthine-containing products during the study.

• Use of St. John's Wort during the study.

• Has donated 500 nL or more blood within 56 days of dosing or plans to donate blood in the month following study participation.

• Previously received any GLP-1 mimetic that has moe than 70% sequence homology to GLP-1.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• GSK716155 subcutaneous injections
albiglutide subcutaneous injection

Biological:
• placebo injection
placebo injection

Locations

Country	Name	City	State
United States	GSK Investigational Site	Honolulu	Hawaii
United States	GSK Investigational Site	Miramar	Florida
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood plasma levels of GSK716155		on days 2 & 9	No
Secondary	blood plasma levels of GSK716155		on days 2 & 9	No

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.