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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Globin Zinc
Insulin glulisine
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014