Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus
NCT ID: NCT00467376
Last Updated: 2009-09-15
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
485 participants
INTERVENTIONAL
2007-01-31
Brief Summary
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* To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus.
* To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.
Secondary:
* To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus
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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
Study Groups
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1
Administration of Insulin Glulisine
Insulin Glulisine
3 times a day before each meal
Insulin Glargine
once daily
2
Administration of Lispro
Lispro
3 times a day before each meal
Insulin Glargine
once daily
Interventions
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Insulin Glulisine
3 times a day before each meal
Lispro
3 times a day before each meal
Insulin Glargine
once daily
Eligibility Criteria
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Inclusion Criteria
* Measure HbA1c 6.5% to 11.0% at visit 1
* More than 3 months of continuous insulin treatment immediately prior to study entry
Exclusion Criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 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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Jing Fu
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis
Beijing, , China
Countries
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Other Identifiers
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APIDR_L_00348
Identifier Type: -
Identifier Source: org_study_id
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