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A Study In Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00256867
First Posted: November 22, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
November 18, 2005
November 22, 2005
October 12, 2017
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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: 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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Mexico,   Philippines,   Puerto Rico,   United States
 
 
NCT00256867
AVS101946
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2016

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