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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00653341
First received: April 1, 2008
Last updated: April 17, 2009
Last verified: April 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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
Study Completion Date: October 2001
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, 08807
Canada
Sanofi-aventis administrative office
Laval, Canada
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Public Registry ICD Sanofi
  More Information

Publications:

Responsible Party: ICD Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00653341     History of Changes
Other Study ID Numbers: HOE901/4002
Study First Received: April 1, 2008
Last Updated: April 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
insulin naive

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

ClinicalTrials.gov processed this record on May 16, 2013