Insulin Glargine in Type 2 Diabetic Patients (TARGET)

Treatment of Early Insulinization With Glargine in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea or Metformin Monotherapy

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin Glargine; Drug: Metformin; Drug: Glyburide; Drug: Glyclazide; Drug: Glimiperide; Drug: Glipizide

• Study Type: Interventional
• Enrollment (Actual): 387
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Metformin; Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A1c values	At baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events including hypoglycemia	From the beginning to the end of the study

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Bruno Jolain, Sanofi

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: June 30, 2006
• First Submitted That Met QC Criteria: June 30, 2006
• First Posted (Estimate): July 4, 2006

Study Record Updates

• Last Update Posted (Estimate): September 15, 2009
• Last Update Submitted That Met QC Criteria: September 14, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin; Insulin Glargine; Gliclazide; Glipizide; Glyburide
• Other Study ID Numbers: LANTU_L_01051