Status:
COMPLETED
Insulin Glargine Combination Therapies in Type II Diabetics
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
35-75 years
Phase:
PHASE3
Brief Summary
To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of change of HbA1c (b...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diabetes mellitus patients type 2, poorly controlled with oral antidiabetic drug treatment(glimepiride 3 or 4 mg od or any sulfonylurea similar to glimepiride 3 or 4 mg in combination with metformin in a dose at least similar to 850 mg once daily)
- HbA1c value ≥ 7.5 % to ≤ 10.5 %
- FBG ≥ 120 mg/dl (6.6 mmol/l)
- BMI ≤ 35 kg/m²
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00783744
Start Date
December 1 2001
Last Update
September 28 2009
Active Locations (10)
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1
Sanofi aventis administrative office
Vienna, Austria
2
Sanofi-aventis administrative office
Helsinki, Finland
3
Sanofi-aventis administrative office
Paris, France
4
Sanofi-Aventis Administrative Office
Berlin, Germany