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A Study In Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00256867
First received: November 18, 2005
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

This study evaluates the effect of medicines for type 2 diabetes and lipids control. This study will require about 6 office visits for lab tests and examinations. All study related medicines and medical examinations will be provided at no cost to the subjects.


Condition Intervention Phase
Non-Insulin-Dependent Diabetes Mellitus
 Drug: GSK523338
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 16 Week Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of a New Medication (GSK523338) to Lower LDL-c and HbA1c in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Efficacy of GSK523338 to lower HbA1c and LDL-c

Secondary Outcome Measures:
  • Safety and tolerability of GSK523338 in patients with type 2 diabetes

Estimated Enrollment: 360
Study Start Date: August 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GSK523338
    Other Name: GSK523338
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • A clinical diagnosis type 2 diabetes mellitus.
  • Women must not be pregnant or breastfeeding during the study and 30 days after the study.
  • Must sign an informed consent form at the study clinic.

Exclusion criteria:

  • Severe chronic diseases that would prevent from participating and completing the study by investigator's judgement.
  • Use of an investigational drug within 30 days or 5 half lives before first dose of study medication.
  • Insulin use for > 1 week in past 3 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256867

  Show 80 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD, PhD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00256867     History of Changes
Other Study ID Numbers: AVS101946
Study First Received: November 18, 2005
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
Type 2 diabetes Type II

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

ClinicalTrials.gov processed this record on June 17, 2013