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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

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Sanofi

Status and phase

Completed
Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Insulin glulisine
Drug: Insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT01159353
APIDR_C_01160
2006-005536-24 (EudraCT Number)

Details and patient eligibility

About

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

Full 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).

Enrollment

37 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

37 participants in 2 patient groups

insulin glulisine + insulin aspart
Experimental group
Description:
insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day)
Treatment:
Drug: Insulin aspart
Drug: Insulin glulisine
insulin aspart + insulin glulisine
Experimental group
Description:
insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day)
Treatment:
Drug: Insulin aspart
Drug: Insulin glulisine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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