Insulin Glargine in Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Gliclazide; Glipizide; Glyburide; Insulin; Insulin Glargine; Insulin, Globin Zinc; Metformin

Criteria

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.