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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

July 8, 2010
July 15, 2010
September 2007
April 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01159353 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart
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

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

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).
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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 glulisine + insulin aspart
    insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day)
    Interventions:
    • Drug: Insulin glulisine
    • Drug: Insulin aspart
  • Experimental: insulin aspart + insulin glulisine
    insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day)
    Interventions:
    • Drug: Insulin glulisine
    • Drug: Insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
April 2008
April 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01159353
APIDR_C_01160, 2006-005536-24
No
Medical Affairs Study Director, Sanofi-aventis
Sanofi
Not Provided
Not Provided
Sanofi
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP