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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
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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
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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 related topics: Hypoglycemia

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia

Secondary Outcome Measures :
  1. Safety data (Adverse events, vital signs, laboratory values, etc.)

Eligibility Criteria
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Information from the National Library of Medicine

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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
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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
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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
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Study Director: Public Registry ICD Sanofi
More Information
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Publications of Results:

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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:
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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