Status:
COMPLETED
Insulin Glargine in Type 2 Diabetic Patients
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 hy...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
387 Patients enrolled
Trial Details
Trial ID
NCT00347100
Start Date
June 1 2006
Last Update
September 15 2009
Active Locations (1)
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1
Sanofi-Aventis
Beijing, China