Status:
COMPLETED
Insulin Glulisine in Type 2 Diabetes Mellitus
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Primary objective: 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 ty...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Type 2 diabetes mellitus
- 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 :
- Type 1 diabetes mellitus, as defined by the World Health Organization
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00310297
Start Date
November 1 2004
Last Update
January 11 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.