Insulin Glulisine in Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open Label, Two-arm, Cross-over Design Study to Compare the Pharmacodynamics and Pharmacokinetics of Insulin Glulisine and Insulin Lispro in Obese Patients With Type 2 Diabetes.

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin Glulisine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin Glulisine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) | 
| Maximum concentration (Cmax, μIU/mL) |  | During the study conduct | 
| Adverse events collection |  | from the inform consnet signed up to the end of the study | 
| Time to maximum concentration (Tmax, min) |  | During the study conduct |