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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00135083 |
The purpose of this study is to show the non-inferiority of insulin glulisine administered with 1 meal versus 2 meals versus 3 daily meals, as measured by the change in hemoglobin A1c (HbA1c), from baseline to study week 24.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: insulin glulisine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | One Versus Two Versus Three Daily Rapid-Acting Insulin Injections of APIDRA (Insulin Glulisine) as Add-on to Lantus® and Oral Sensitizer Basal Therapy in Type 2 Diabetes: a Multicenter, Randomized, Parallel, Open-Label Clinical Study |
Enrollment: | 347 |
Study Start Date: | August 2004 |
Study Completion Date: | November 2007 |
Arms | Assigned Interventions |
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1: Experimental
Once daily:
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Drug: insulin glulisine
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2: Experimental
Twice daily:
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Drug: insulin glulisine
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3: Experimental
Twice daily:
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Drug: insulin glulisine
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Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Subjects with type 2 diabetes mellitus who have been using a stable combination oral antidiabetic therapy of 2 or 3 agents in different therapeutic classes for on at least 3 months will be enrolled in this study.
Inclusion Criteria:
Current treatment with a stable dose of 2 oral antidiabetic agents. The oral agents must be in 2 or 3 of the following 3 different classes:
Exclusion Criteria:
Responsible Party: | sanofi-aventis ( Study Director ) |
Study ID Numbers: | HMR1964A/3511 |
Study First Received: | August 23, 2005 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00135083 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hypoglycemic Agents Insulin glulisine Metabolic Diseases Diabetes Mellitus, Type 2 Glargine Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Insulin glulisine Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |