A Study In Patients With Type 2 Diabetes Mellitus
This study has been completed.
Information provided by:
First received: November 18, 2005
Last updated: February 11, 2013
Last verified: February 2013
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.
Non-Insulin-Dependent Diabetes Mellitus
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2006 (Final data collection date for primary outcome measure)
Other Name: GSK523338
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256867
||GSK Clinical Trials, MD, PhD
No publications provided
||Study Director, GSK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 18, 2005
||February 11, 2013
||United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases