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Sponsored by: |
Sanofi-Aventis |
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00384215 |
This trial will explore the various advantages and possible disadvantages of pioglitazone and insulin glargine when added to monotherapy. Glycemic control, hypoglycemia, weight, lipid profiles, quality of life and cost will be studied given a comprehensive set of data that may help future treatment decisions.
Condition | Intervention | Phase |
Diabetes Mellitus, Type 2 |
Drug: insulin glargine [rDNA origin] injection |
Phase IV |
MedlinePlus related topics: | Diabetes Hypoglycemia |
Drug Information available for: | Insulin Insulin glargine Pioglitazone Pioglitazone hydrochloride Metformin Metformin hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as Add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin: a Randomized, Open, Parallel Study |
Estimated Enrollment: | 352 |
Study Start Date: | December 2001 |
Estimated Study Completion Date: | February 2005 |
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Related Info 
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Responsible Party: | sanofi-aventis ( Study Director ) |
Study ID Numbers: | HOE901/4020 |
First Received: | October 4, 2006 |
Last Updated: | March 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00384215 |
Health Authority: | United States: Food and Drug Administration |
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