Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)
NCT ID: NCT00653341
Last Updated: 2009-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
764 participants
INTERVENTIONAL
2000-01-31
2001-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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insulin glargine
NPH human insulin
Eligibility Criteria
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Inclusion Criteria
* 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
30 Years
70 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Sanofi-aventis
Principal Investigators
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Public Registry ICD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-aventis administrative office
Bridgewater, New Jersey, United States
Sanofi-aventis administrative office
Laval, , Canada
Countries
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References
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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.
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.
Other Identifiers
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HOE901/4002
Identifier Type: -
Identifier Source: org_study_id
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