Type 2 Diabetes Mellitus
Conditions
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 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.
Interventions
DRUGInsulin Glulisine
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma glucose concentration (GLUmax, mmol/L) | During the Study Conduct |
| Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L) | during the study conduct |
| Time to GLUmax (Tmax, min) | during the study conduct |
Secondary
| Measure | Time frame |
|---|---|
| Area under the insulin concentration-time curve after injection(μIU.min/mL) | between 0 h and 1 h (AUC0-1h), 0 h and 1.5 h (AUC0-1.5h), 0 h and 2 h (AUC0-2h) and 0 h and 4 h (AUC0-4h) |
| Time to maximum concentration (Tmax, min) | During the study conduct |
| Maximum concentration (Cmax, μIU/mL) | During the study conduct |
| Adverse events collection | from the inform consnet signed up to the end of the study |
Outcome results
None listed