Trial record 1 of 4543 for:    "Diabetes Mellitus, Type 2"
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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014