Back to resultsEffect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin glargine
NPH human insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring insulin naive
Eligibility 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
Sites / Locations
- Sanofi-aventis administrative office
- Sanofi-aventis administrative office
Outcomes
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.)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00653341
Brief Title
Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)
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 Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
October 2001 (Actual)
Study Completion Date
October 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
insulin naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
764 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Type
Drug
Intervention Name(s)
NPH human insulin
Primary Outcome Measure Information:
Title
Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia
Secondary Outcome Measure Information:
Title
Safety data (Adverse events, vital signs, laboratory values, etc.)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Public Registry ICD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-aventis administrative office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-aventis administrative office
City
Laval
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
14578243
Citation
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. doi: 10.2337/diacare.26.11.3080.
Results Reference
result
PubMed Identifier
33166419
Citation
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(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
Results Reference
derived
Learn more about this trial
Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)
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