Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart

NCT ID: NCT01159353

Last Updated: 2010-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-04-30

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 subjects with type 2 diabetes.

Secondary Objectives:

Pharmacodynamic objectives:

• To assess the effect of insulin glulisine on the postprandial plasma glucose excursion during 6 hours after a standard meal in comparison to insulin aspart.

Pharmacokinetic objective:

• To assess post-prandial plasma insulin excursion after a standard meal, in each treatment groups

Safety objective:

• To assess the safety of insulin glulisine in comparison to insulin aspart

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 study days),
• Follow-up visit (within 2 weeks after the end of the study treatment period).

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

insulin glulisine + insulin aspart

insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day)

Group Type: EXPERIMENTAL

Insulin glulisine

Intervention Type: DRUG

Insulin glulisine 100 U/ml, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal

Insulin aspart

Intervention Type: DRUG

Insulin aspart: 100 U/mL, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal

insulin aspart + insulin glulisine

insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day)

Group Type: EXPERIMENTAL

Insulin glulisine

Intervention Type: DRUG

Insulin glulisine 100 U/ml, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal

Insulin aspart

Intervention Type: DRUG

Insulin aspart: 100 U/mL, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal

Interventions

Insulin glulisine

Insulin glulisine 100 U/ml, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal

Intervention Type: DRUG

Insulin aspart

Insulin aspart: 100 U/mL, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal

Intervention Type: DRUG

Other Intervention Names

Apidra; NovoRapid

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Sanofi-aventis

Locations

Sanofi-Aventis Administrative Office

Paris, , France

Countries

France

Other Identifiers

2006-005536-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

APIDR_C_01160

Identifier Type: -

Identifier Source: org_study_id