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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00653341

Recruitment Status : Completed

First Posted : April 4, 2008

Last Update Posted : April 20, 2009

Sponsor:

Information provided by:

Sanofi

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Drug: insulin glargine Drug: NPH human insulin	Phase 3

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	764 participants
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.
Study Start Date :	January 2000
Actual Primary Completion Date :	October 2001
Actual Study Completion Date :	October 2001

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Type 2 diabetes

MedlinePlus related topics: Hypoglycemia

Drug Information available for: Insulin Insulin human Insulin, isophane Insulin glargine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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.)

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	30 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653341

Locations

Layout table for location information

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

Layout table for investigator information

Study Director:	Public Registry ICD	Sanofi

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11:CD005613. doi: 10.1002/14651858.CD005613.pub4.

Layout table for additonal information

Responsible Party:	ICD Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00653341
Other Study ID Numbers:	HOE901/4002
First Posted:	April 4, 2008 Key Record Dates
Last Update Posted:	April 20, 2009
Last Verified:	April 2009

Keywords provided by Sanofi:


insulin naive

Additional relevant MeSH terms:

Layout table for MeSH terms

Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin Insulin, Globin Zinc	Insulin Glargine Isophane Insulin, Human Insulin, Isophane Isophane insulin, beef Hypoglycemic Agents Physiological Effects of Drugs

To Top