Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin)
Overview[ - collapse ][ - ]
Purpose | Primary objective: To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level Secondary objective: To compare the incidence of hypoglycemia in each treatment group |
---|---|
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Glimepiride Drug: Metformin Drug: Insulin Glargine |
Phase | Phase 4 |
Sponsor | Sanofi |
Responsible Party | Sanofi |
ClinicalTrials.gov Identifier | NCT00708578 |
First Received | June 27, 2008 |
Last Updated | January 24, 2011 |
Last verified | January 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | June 27, 2008 |
---|---|
Last Updated Date | January 24, 2011 |
Start Date | May 2008 |
Estimated Primary Completion Date | December 2009 |
Current Primary Outcome Measures | HbA1c values [Time Frame: At baseline to end of treatment] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin) |
---|---|
Official Title | Insulin Glargine Combined With Sulfonylurea Versus Metformin in Patients With Type 2 Diabetes: A Randomized, Controlled Trial. |
Brief Summary | Primary objective: To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level Secondary objective: To compare the incidence of hypoglycemia in each treatment group |
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 | Type 2 Diabetes Mellitus |
Intervention | Drug: Glimepiride Once a day before breakfast Drug: Metformin After breakfast and supper Drug: Insulin Glargine Injection in the morning |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
---|---|
Estimated Enrollment | 99 |
Estimated Completion Date | December 2009 |
Estimated Primary Completion Date | December 2009 |
Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes for at least 6 months - Treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea (glimepiride≥ 4 mg/day or equivalent dose of other SU) for at least 3 months prior to the screening visit - 7.0 < HbA1c < 11 % - Fasting serum C-peptide > 0.33 nmol/L - BMI < 30 kg/m² - Patients who is willing to monitor BG using SMBG Exclusion Criteria: - Type 1 Diabetes - Clinical evidence of active liver disease, or serum ALT 3 times the upper limit of the normal range - Serum creatinine: ≥ 1.5 mg/dl for males, ≥ 1.4 mg/dl for females - Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry) - History of alcohol or other substance abuse - Pregnancy or not using contraceptive in childbearing aged women - Breast feeding women - History of hypersensitivity to the study drugs or to drugs with a similar chemical structure - Treatment with any medication including corticosteroid or herbal medicines that can affect blood glucose level within 3 months prior to study entry except metformin and sulfonylurea. 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 | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00708578 |
---|---|
Other Study ID Numbers | LANTU_L_02670 |
Has Data Monitoring Committee | No |
Information Provided By | Sanofi |
Study Sponsor | Sanofi |
Collaborators | Not Provided |
Investigators | Study Director: Ji Young Ahn Sanofi |
Verification Date | January 2011 |
Locations[ + expand ][ + ]
Sanofi-Aventis Administrative Office | Seoul, Korea, Republic of |
---|