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

November 18, 2005
February 11, 2013
August 2005
October 2006   (final data collection date for primary outcome measure)
Efficacy of GSK523338 to lower HbA1c and LDL-c
Same as current
Complete list of historical versions of study NCT00256867 on ClinicalTrials.gov Archive Site
Safety and tolerability of GSK523338 in patients with type 2 diabetes
Same as current
Not Provided
Not Provided
 
A Study In Patients With Type 2 Diabetes Mellitus
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Non-Insulin-Dependent Diabetes Mellitus
Drug: GSK523338
Other Name: GSK523338
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
October 2006
October 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Mexico,   Philippines,   Puerto Rico
 
NCT00256867
AVS101946
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD, PhD GlaxoSmithKline
GlaxoSmithKline
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP