|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00329225 |
Purpose
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, 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: | September 2002 |
| Study Completion Date: | April 2004 |
| Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 124 Study Locations| Study Director: | GSK Clinical Trials, MD, PhD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 49653/347 |
| Study First Received: | May 22, 2006 |
| Last Updated: | October 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00329225 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Type 2 Diabetes Mellitus Thiazolidinediones Insulin |
|
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Glucose Metabolism Disorders Rosiglitazone Pharmacologic Actions Insulin |