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
PHASE1
INTERVENTIONAL
2004-11-30
Brief Summary
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To compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects with type 2 diabetes.
Secondary objectives:
* To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese subjects with type 2 diabetes, injected subcutaneously before three standard meals during a 12-hour day.
* The safety of insulin glulisine, the relationship of the pharmacodynamics and pharmacokinetics with skin thickness and C-peptide, non-esterified fatty acid, triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Interventions
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Insulin Glulisine
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 35 and 40 kg/m2
* HbA1c ≤10%
* Plasma C-peptide levels ≥0.1 nmol/L.
* Female subjects have to either be postmenopausal, surgically sterilized, or not pregnant and using approved methods of contraception.
Exclusion Criteria
* Subjects currently taking any insulin
* History of hypoglycaemic unawareness
* Injection site skin thickness \< or = 8 mm
* Contra-indications from
* The medical history and physical examination
* Laboratory tests (haematology, clinical chemistry, and urinalysis by dipstick)
* Blood pressure and pulse
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Valérie Pilorget, MD
Role: STUDY_DIRECTOR
Sanofi
Other Identifiers
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HMR1964A_1505
Identifier Type: -
Identifier Source: org_study_id
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