TARGET: Insulin Glargine in Type 2 Diabetic Patients
Study Details
Study Description
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)
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To investigate whether beta cell function is preserved if this therapy is initiated before 2nd OAD (oral anti-diabetic drug) failure
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Administration of Insulin Glargine and Sulfonylurea or Metformin |
Drug: Insulin Glargine
Throughout study period
Drug: Metformin
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
|
| Active Comparator: 2 Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin |
Drug: Glyburide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Drug: Glyclazide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Drug: Glimiperide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Drug: Glipizide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Drug: Metformin
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
|
Outcome Measures
Primary Outcome Measures
- A1c values [At baseline and 24 weeks]
Secondary Outcome Measures
- Adverse events including hypoglycemia [From the beginning to the end of the study]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis | Beijing | China |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Bruno Jolain, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LANTU_L_01051