Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00530309
First received: September 14, 2007
Last updated: June 21, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Drug: GSK716155 for injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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-

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Plasma concentrations and PD parameters over time and at the end of study

Secondary Outcome Measures:
  • Other metabolic parameters at the end of study

Estimated Enrollment: 40
Study Start Date: August 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GSK716155 for injection
    Other Name: GSK716155 for injection
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530309

Locations
Japan
GSK Investigational Site
Fukuoka, Japan, 812-0025
GSK Investigational Site
Tokyo, Japan, 130-0004
GSK Investigational Site
Tokyo, Japan, 160-0017
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00530309     History of Changes
Other Study ID Numbers: GLP107865
Study First Received: September 14, 2007
Last Updated: June 21, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
GLP-1 receptor agonist,
GSK716155,
type 2 diabetes mellitus,
pharmacokinetics,
GLP-1,
safety,
pharmacodynamics,
tolerability

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014