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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Double Blind Study to Assess the Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159353
• Other study ID #: APIDR_C_01160
• Secondary ID: 2006-005536-24
• Status: Completed
• Phase: Phase 1
• First received: July 8, 2010
• Last updated: July 15, 2010
• Start date: September 2007
• Est. completion date: April 2008

Study information

• Verified date: July 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
France	Sanofi-Aventis Administrative Office	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma glucose concentration curve (AUC) between 0 and 1 hour after insulin injection AUC(0-1h)		At day 1 of each treatment period	No
Secondary	Area under the curve of plasma glucose concentration AUC(0-2h)		At day 1 of each treatment period	No
Secondary	Area under the curve of plasma glucose concentration AUC(0-4h)		At day 1 of each treatment period	No
Secondary	Area under the curve of plasma glucose concentration AUC(0-6h)		At day 1 of each treatment period	No
Secondary	Delta plasma glucose at 1h after standard meal		At day 1 of each treatment period	No
Secondary	Maximum glucose concentration (GLU max)		At day 1 of each treatment period	No
Secondary	Maximum glucose excursion (delta GLU max)		At day 1 of each treatment period	No
Secondary	Time to delta GLU max		At day 1 of each treatment period	No
Secondary	Time to fraction of total glucose AUC(10%, 20%)		At day 1 of each treatment period	No
Secondary	Area under the plasma insulin concentration curve AUC (0-1h)		At day 1 of each treatment period	No
Secondary	Area under the plasma insulin concentration curve AUC (0-2h)		At day 1 of each treatment period	No
Secondary	Area under the plasma insulin concentration curve AUC (0-4h)		At day 1 of each treatment period	No
Secondary	Area under the plasma insulin concentration curve AUC (0-6h)		At day 1 of each treatment period	No
Secondary	Maximum insulin concentration (Cmax)		At day 1 of each treatment period	No
Secondary	Time to fraction of total insulin AUC (10%, 20%)		At day 1 of each treatment period	No
Secondary	Time to Cmax		At day 1 of each treatment period	No
Secondary	Hypoglycaemia and adverse events		from randomization to the end of study	Yes