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
  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:


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
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: 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 August 28, 2014