Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s) - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00653341

Purpose

The primary objective of this study is to compare the percentage of subjects who reach the target HbA1c level (< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during treatment with insulin glargine or NPH human insulin.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: insulin glargine Drug: NPH human insulin	Phase III

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Insulin Insulin glargine Insulin, isophane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Target Glycemic Control and the Incidence of Symptomatic Nocturnal Hypoglycemia in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or NPH Human Insulin.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia

Secondary Outcome Measures:

Safety data (Adverse events, vital signs, laboratory values, etc.)

Enrollment:	764
Study Start Date:	January 2000
Primary Completion Date:	October 2001 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Insulin naïve subjects with type 2 diabetes treated with oral hypoglycemic agents
Body mass index between 26 and 40 kg/m2
HbA1c between 7.5% and 10.0%
Fasting plasma glucose >7.8 mmol/L and fasting C-peptide > or =0.25 nmol/L

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653341

Locations

United States, New Jersey
Sanofi-aventis administrative office
Bridgewater, New Jersey, United States
Canada
Sanofi-aventis administrative office
Laval, Canada

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Public Registry ICD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications of Results:

Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003 Nov;26(11):3080-6.

Responsible Party:	Sanofi-aventis ( ICD Study Director )
Study ID Numbers:	HOE901/4002, HOE901
Study First Received:	April 1, 2008
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00653341
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

insulin naive

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia
Insulin, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009