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Insulin Glargine in Type 2 Diabetic Patients (TARGET)
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00347100
  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 IV

MedlinePlus related topics: Diabetes Hypoglycemia
Drug Information available for: Insulin Insulin glargine Glyburide Glipizide Metformin Metformin hydrochloride Gliclazide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Treatment of Early Insulinization With Glargine in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea or Metformin Monotherapy

Further study details as provided by Sanofi-Aventis:

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
1: Experimental
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.
2: Active Comparator
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347100

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

Responsible Party: sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers: LANTU_L_01051
Study First Received: June 30, 2006
Last Updated: November 6, 2008
ClinicalTrials.gov Identifier: NCT00347100  
Health Authority: China: State Food and Drug Administration

Study placed in the following topic categories:
Glyburide
Metabolic Diseases
Glipizide
Gliclazide
Metformin
Diabetes Mellitus
Endocrine System Diseases
 Insulin
Diabetes Mellitus, Type 2
Glargine
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009



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