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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.
Information provided by:
Sanofi Identifier:
First received: April 1, 2008
Last updated: April 17, 2009
Last verified: April 2009
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
Intervention Model: Parallel Assignment
Masking: None (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)

Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00653341

United States, New Jersey
Sanofi-aventis administrative office
Bridgewater, New Jersey, United States, 08807
Sanofi-aventis administrative office
Laval, Canada
Sponsors and Collaborators
Study Director: Public Registry ICD Sanofi
  More Information

Responsible Party: ICD Study Director, Sanofi-aventis Identifier: NCT00653341     History of Changes
Other Study ID Numbers: HOE901/4002
Study First Received: April 1, 2008
Last Updated: April 17, 2009

Keywords provided by Sanofi:
insulin naive

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin Glargine
Hypoglycemic Agents
Isophane Insulin, Human
Insulin, Isophane
Physiological Effects of Drugs processed this record on September 19, 2017