Status:
COMPLETED
Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin)
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 S...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00708578
Start Date
May 1 2008
End Date
December 1 2009
Last Update
January 25 2011
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Seoul, South Korea