Status:
COMPLETED
Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Primary Objective: * To assess the effect of insulin glulisine on the post-prandial plasma glucose excursion during the first hour after a standard meal in comparison to insulin aspart in obese subje...
Detailed Description
Duration of treatment: two study days separated by a 7-day wash-out period Duration of observation: * screening period of 1-2 weeks, \>2 study days (with a wash-out period of 7 days between the stud...
Eligibility Criteria
Inclusion
- patients with type 2 diabetes for at least one year
- treated with oral antidiabetic agents (OADs) for at least 6 months
- Baseline C-peptide ≥0.1 nmol/L
- BMI (body mass index) between 30 and 40 kg/m2
- HbA1c (glycosylated hemoglobin) \< 8.5%
- signed informed consent
Exclusion
- type I diabetes mellitus
- current treatment with insulin
- pregnant and breast-feeding women
- any medication known to influence insulin sensitivity
- current treatment with systemic corticosteroids
- history of acute metabolic complications in the past 3 months
- recurrent severe hypoglycaemia or hypoglycaemic unawareness
- active proliferative diabetic retinopathy and known diabetic gastroparesis
- impaired hepatic function, as shown but not limited to ALT or AST above 2 times the upper limit of normal
- clinically relevant illness such as nephropathy and impaired renal function as shown by clearance \< 30 ml/min
- any history or presence of clinically relevant abnormality, medical condition (cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, ocular or infectious disease; any acute infectious disease or signs of acute illness making implementation of the protocol or interpretation of the results difficult
- hypersensitivity to insulins or insulin analogs
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01159353
Start Date
September 1 2007
End Date
April 1 2008
Last Update
July 16 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Paris, France