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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00562172 |
Primary objective:
To compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients
Secondary objective:
To assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus |
Drug: Insulin glargine Drug: Glimepiride Drug: Metformin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Lantus vs Sulfonylurea as Add-on Therapy in Type 2 Diabetic Patients Failing Metformin Monotherapy: Comparison of Effects on Beta Cell Function and Metabolic Profile. |
Estimated Enrollment: | 74 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Insulin glargine
Once daily in the morning
Drug: Metformin
At least 1000 mg/day
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2: Active Comparator |
Drug: Glimepiride
Once daily in the morning
Drug: Metformin
At least 1000 mg/day
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
List of Inclusion and Exclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact: Public Registry GMA | publicregistryGMA@sanofi-aventis.com |
Korea, Republic of | |
Sanofi-aventis | Recruiting |
Seoul, Korea, Republic of |
Study Director: | Ji Young Ahn | Sanofi-Aventis |
Responsible Party: | Sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | LANTU_L_02193 |
Study First Received: | November 15, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00562172 History of Changes |
Health Authority: | Korea: Institutional Review Board of Severance Hospital |
Metabolic Diseases Immunologic Factors Metformin Diabetes Mellitus Endocrine System Diseases Cardiovascular Agents Immunosuppressive Agents Insulin |
Glimepiride Hypoglycemic Agents Diabetes Mellitus, Type 2 Glargine Anti-Arrhythmia Agents Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Immunologic Factors Metformin Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Cardiovascular Agents Immunosuppressive Agents Insulin |
Pharmacologic Actions Glimepiride Hypoglycemic Agents Therapeutic Uses Diabetes Mellitus, Type 2 Glargine Anti-Arrhythmia Agents Glucose Metabolism Disorders |