Insulin Glargine in Type 2 Diabetic Patients - Full Text View - ClinicalTrials.gov

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Insulin Glargine in Type 2 Diabetic Patients (TARGET)

This study has been completed.

First Received on June 30, 2006. Last Updated on September 14, 2009 History of Changes

Sponsor:	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

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Hypoglycemia

Drug Information available for: Glyburide Insulin Insulin beef Gliclazide Glipizide Insulin glargine Metformin Metformin hydrochloride

U.S. FDA Resources

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)

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

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

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: State Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Glyburide
Gliclazide

Glipizide
Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012

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