Insulin Glargine in Type 2 Diabetic Patients (TARGET)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00347100
First received: June 30, 2006
Last updated: September 14, 2009
Last verified: September 2009
  Purpose

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

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Glargine
Drug: Glyburide
Drug: Glyclazide
Drug: Glimiperide
Drug: Glipizide
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Early Insulinization With Glargine in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea or Metformin Monotherapy

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • A1c values [ Time Frame: At baseline and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events including hypoglycemia [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: Yes ]

Enrollment: 387
Study Start Date: June 2006
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347100

Locations
China
Sanofi-Aventis
Beijing, China
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Bruno Jolain Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00347100     History of Changes
Other Study ID Numbers: LANTU_L_01051
Study First Received: June 30, 2006
Last Updated: September 14, 2009
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Glipizide
Glyburide
Insulin
Insulin, Long-Acting
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014