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Insulin Glargine in Type 2 Diabetic Patients (TARGET)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00347100
First Posted: July 4, 2006
Last Update Posted: September 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347100


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00347100     History of Changes
Other Study ID Numbers: LANTU_L_01051
First Submitted: June 30, 2006
First Posted: July 4, 2006
Last Update Posted: September 15, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Metformin
Insulin Glargine
Glyburide
Glipizide
Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs