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.
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
||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 March 26, 2015
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders