Insulin Glargine in Type 2 Diabetic Patients
Phase 4
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: GlyclazideDrug: Glimiperide
- Registration Number
- NCT00347100
- Lead Sponsor
- Sanofi
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 387
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Insulin Glargine Administration of Insulin Glargine and Sulfonylurea or Metformin 1 Metformin Administration of Insulin Glargine and Sulfonylurea or Metformin 2 Glimiperide Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin 2 Glyburide Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin 2 Glyclazide Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin 2 Glipizide Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin 2 Metformin Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
- Primary Outcome Measures
Name Time Method A1c values At baseline and 24 weeks
- Secondary Outcome Measures
Name Time Method Adverse events including hypoglycemia From the beginning to the end of the study
Trial Locations
- Locations (1)
Sanofi-Aventis
🇨🇳Beijing, China