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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01159353
First received: July 8, 2010
Last updated: July 15, 2010
Last verified: July 2010
History of Changes
  Purpose

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

Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Insulin glulisine
Drug: Insulin aspart
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Area under the plasma glucose concentration curve (AUC) between 0 and 1 hour after insulin injection AUC(0-1h) [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the curve of plasma glucose concentration AUC(0-2h) [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]
  • Area under the curve of plasma glucose concentration AUC(0-4h) [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]
  • Area under the curve of plasma glucose concentration AUC(0-6h) [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]
  • Delta plasma glucose at 1h after standard meal [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]
  • Maximum glucose concentration (GLU max) [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]
  • Maximum glucose excursion (delta GLU max) [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]
  • Time to delta GLU max [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]
  • Time to fraction of total glucose AUC(10%, 20%) [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]
  • Area under the plasma insulin concentration curve AUC (0-1h) [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]
  • Area under the plasma insulin concentration curve AUC (0-2h) [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]
  • Area under the plasma insulin concentration curve AUC (0-4h) [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]
  • Area under the plasma insulin concentration curve AUC (0-6h) [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]
  • Maximum insulin concentration (Cmax) [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]
  • Time to fraction of total insulin AUC (10%, 20%) [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]
  • Time to Cmax [ Time Frame: At day 1 of each treatment period ] [ Designated as safety issue: No ]
  • Hypoglycaemia and adverse events [ Time Frame: from randomization to the end of study ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: September 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin glulisine + insulin aspart
insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day)
 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
Other Name: Apidra
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
Other Name: NovoRapid
Experimental: insulin aspart + insulin glulisine
insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day)
 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
Other Name: Apidra
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
Other Name: NovoRapid

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).
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159353

Locations
France
Sanofi-Aventis Administrative Office
Paris, France
Sponsors and Collaborators
Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT01159353     History of Changes
Other Study ID Numbers: APIDR_C_01160, 2006-005536-24
Study First Received: July 8, 2010
Last Updated: July 15, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
 Insulin glulisine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013