Insulin Glargine in Type 2 Diabetic Patients (TARGET)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin Glargine; Drug: Metformin; Drug: Glyclazide; Drug: Glimiperide; Drug: Glyburide; Drug: Glipizide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00347100

LANTU_L_01051

Details and patient eligibility

About

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

Enrollment: 387 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

387 participants in 2 patient groups

1

Experimental group

Description:

Administration of Insulin Glargine and Sulfonylurea or Metformin

Treatment:

Drug: Metformin

Drug: Insulin Glargine

2

Active Comparator group

Description:

Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin

Treatment:

Drug: Glimiperide

Drug: Glipizide

Drug: Glyclazide

Drug: Metformin

Drug: Glyburide