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Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00329225 |
This 24-week study will compare the effects of adding the drug rosiglitazone (2mg and 4mg) or placebo to insulin in patients with Type 2 diabetes mellitus (non-insulin-dependent) who have not achieved their blood glucose goal using insulin alone. This study requires a total of seven visits during 28 weeks.
Condition | Intervention | Phase |
Non-Insulin-Dependent Diabetes Mellitus |
Drug: rosiglitazone |
Phase III |
MedlinePlus related topics: | Diabetes |
ChemIDplus related topics: | Insulin Rosiglitazone Rosiglitazone Maleate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone (2mg and 4mg) Compared to Insulin Plus Placebo for 24 Weeks in Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Insulin |
Estimated Enrollment: | 630 |
Study Start Date: | November 2002 |
Study Completion Date: | April 2004 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 140 Study Locations |
GlaxoSmithKline |
Study Director: | GSK Clinical Trials, MD, PhD | GlaxoSmithKline |
Study ID Numbers: | 49653/347 |
First Received: | May 22, 2006 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00329225 |
Health Authority: | United States: Food and Drug Administration |
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