CClinicalTrials.gg
Sign In
CompletedNCT01159353Updated Jul 16, 2010

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

A Phase 1 interventional study of Insulin glulisine and Insulin aspart in Type 2 Diabetes Mellitus, sponsored by Sanofi. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-07-16.

Sponsored by Sanofi · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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
Read the 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).
02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 37 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    insulin glulisine + insulin aspart

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

    Drug: Insulin glulisine · Drug: Insulin aspart

  • Experimental
    insulin aspart + insulin glulisine

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

    Drug: Insulin glulisine · Drug: Insulin aspart

Interventions

  • DrugInsulin 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

    Also known as: Apidra

  • DrugInsulin 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

    Also known as: NovoRapid

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Area under the curve of plasma glucose concentration AUC(0-2h)

    Time frame: At day 1 of each treatment period

  2. Area under the curve of plasma glucose concentration AUC(0-4h)

    Time frame: At day 1 of each treatment period

  3. Area under the curve of plasma glucose concentration AUC(0-6h)

    Time frame: At day 1 of each treatment period

  4. Delta plasma glucose at 1h after standard meal

    Time frame: At day 1 of each treatment period

  5. Maximum glucose concentration (GLU max)

    Time frame: At day 1 of each treatment period

  6. Maximum glucose excursion (delta GLU max)

    Time frame: At day 1 of each treatment period

  7. Time to delta GLU max

    Time frame: At day 1 of each treatment period

  8. Time to fraction of total glucose AUC(10%, 20%)

    Time frame: At day 1 of each treatment period

  9. Area under the plasma insulin concentration curve AUC (0-1h)

    Time frame: At day 1 of each treatment period

  10. Area under the plasma insulin concentration curve AUC (0-2h)

    Time frame: At day 1 of each treatment period

  11. Area under the plasma insulin concentration curve AUC (0-4h)

    Time frame: At day 1 of each treatment period

  12. Area under the plasma insulin concentration curve AUC (0-6h)

    Time frame: At day 1 of each treatment period

  13. Maximum insulin concentration (Cmax)

    Time frame: At day 1 of each treatment period

  14. Time to fraction of total insulin AUC (10%, 20%)

    Time frame: At day 1 of each treatment period

  15. Time to Cmax

    Time frame: At day 1 of each treatment period

  16. Hypoglycaemia and adverse events

    Time frame: from randomization to the end of study

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Paris, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01159353
Lead sponsor
Sanofi
First posted
Jul 9, 2010
Start date
Sep 2007
Primary completion
Apr 2008
Completion
Apr 2008
Last update
Jul 16, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus→

Other studies from this sponsor

Sanofi

Start the discussion