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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
  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:


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
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, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Hypoglycemic Agents
Insulin
Insulin, Globin Zinc
Insulin, Isophane
Insulin, Long-Acting
Isophane insulin, beef
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014