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| Sponsored by: |
GlaxoSmithKline |
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00069836 |
Purpose
This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both AVANDIA and metformin are medicines which are individually licensed for the treatment of type II diabetes mellitus. Because they act in different ways, it is thought that combining them may give an increased benefit of treating diabetes and reducing blood sugar.
| Condition | Intervention | Phase |
|
Non-Insulin-Dependent Diabetes Mellitus |
Drug: Rosiglitazone/metformin |
Phase III |
| MedlinePlus related topics: | Diabetes |
| ChemIDplus related topics: | Insulin Metformin Metformin hydrochloride Rosiglitazone Rosiglitazone Maleate Avandamet |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A 24 Week, Randomised, Double Blind, Parallel Study to Compare the Change in HbA1c With AVANDAMET* (8.0 mg / 2.0 g) Plus Insulin to Placebo Plus Insulin, in Subjects With Type 2 Diabetes Starting Insulin Therapy |
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 104 Study Locations |
| GlaxoSmithKline |
| Study Director: | GSK Clinical trials, MD FRCP | GlaxoSmithKline |
More Information
| Study ID Numbers: | 712753/009, AVANDAMET Plus Insulin |
| First Received: | October 1, 2003 |
| Last Updated: | June 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00069836 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency; United States: Food and Drug Administration; Spain: Spanish Agency of Medicines |
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