Insulin Glargine in Type 2 Diabetic Patients
Overview[ - collapse ][ - ]
| Purpose | Primary: - To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline to endpoint A1c < 7%) Secondary: - To investigate the safety of insulin glargine (in terms of hypoglycaemia, including symptomatic, non-symptomatic and nocturnal hypoglycaemia) - To investigate whether beta cell function is preserved if this therapy is initiated before 2nd OAD (oral anti-diabetic drug) failure |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Insulin Glargine Drug: Glyburide Drug: Glyclazide Drug: Glimiperide Drug: Glipizide Drug: Metformin |
| Phase | Phase 4 |
| Sponsor | Sanofi |
| Responsible Party | Sanofi |
| ClinicalTrials.gov Identifier | NCT00347100 |
| First Received | June 30, 2006 |
| Last Updated | September 14, 2009 |
| Last verified | September 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 30, 2006 |
|---|---|
| Last Updated Date | September 14, 2009 |
| Start Date | June 2006 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | A1c values [Time Frame: At baseline and 24 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Adverse events including hypoglycemia [Time Frame: From the beginning to the end of the study] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Insulin Glargine in Type 2 Diabetic Patients |
|---|---|
| Official Title | Treatment of Early Insulinization With Glargine in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea or Metformin Monotherapy |
| Brief Summary | Primary: - To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline to endpoint A1c < 7%) Secondary: - To investigate the safety of insulin glargine (in terms of hypoglycaemia, including symptomatic, non-symptomatic and nocturnal hypoglycaemia) - To investigate whether beta cell function is preserved if this therapy is initiated before 2nd OAD (oral anti-diabetic drug) failure |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Insulin Glargine Throughout study period Drug: Glyburide Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl. Drug: Glyclazide Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl. Drug: Glimiperide Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl. Drug: Glipizide Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl. Drug: Metformin Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 387 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | May 2008 |
| Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes patients with first OAD (Sulfonylurea [SU] or Metformin) failure - Patients who are insulin naive (unless it was used for gestational diabetes or if insulin therapy was less than 1 week) - Serum creatinine ≤ 1.5mg/dL - BMI: 21-41 kg/m² - 7.5%< A1c <11% - Fasting plasma glucose > 7.5mmol/L - On diet and exercise therapy and stable OAD treatment (SU or metformin > ½ maximal dose)for more than 1 month prior to enrolment - Women not of childbearing potential (sterilization procedure done or menopausal > 2 years), or if of childbearing potential, agree to take reliable contraceptive measures during the study - Able and willing to monitor blood glucose - Able and willing to perform 7 point blood glucose self monitoring at baseline, 12 week and 24 week - Understand that there is a 50% chance of being randomized to the insulin treatment arm and is willing to self inject insulin Exclusion Criteria: - Type 1 diabetes - Acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma - Pregnancy, breast-feeding - People who work night shifts - Hypersensitivity to investigational drugs or its additives, or intolerability to metformin - Need for use of medications prohibited by the protocol during the study for treatment purpose - Significant diseases in cardiovascular, liver, nerve, endocrine or other systems, unable to complete the study or difficult to be used in study analysis - Drugs or alcohol abuse The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | China |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00347100 |
|---|---|
| Other Study ID Numbers | LANTU_L_01051 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Sanofi |
| Study Sponsor | Sanofi |
| Collaborators | Not Provided |
| Investigators | Study Director: Bruno Jolain Sanofi |
| Verification Date | September 2009 |
Locations[ + expand ][ + ]
| Sanofi-Aventis | Beijing, China |
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