Clinical trial NCT01159353: Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-07-09
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

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 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.

Primary outcomes:
measure: Area under the plasma glucose concentration curve (AUC) between 0 and 1 hour after insulin injection AUC(0-1h)
timeFrame: At day 1 of each treatment period
Secondary outcomes:
measure: Area under the curve of plasma glucose concentration AUC(0-2h)
timeFrame: At day 1 of each treatment period
measure: Area under the curve of plasma glucose concentration AUC(0-4h)
timeFrame: At day 1 of each treatment period
measure: Area under the curve of plasma glucose concentration AUC(0-6h)
timeFrame: At day 1 of each treatment period
measure: Delta plasma glucose at 1h after standard meal
timeFrame: At day 1 of each treatment period
measure: Maximum glucose concentration (GLU max)
timeFrame: At day 1 of each treatment period
measure: Maximum glucose excursion (delta GLU max)
timeFrame: At day 1 of each treatment period
measure: Time to delta GLU max
timeFrame: At day 1 of each treatment period
measure: Time to fraction of total glucose AUC(10%, 20%)
timeFrame: At day 1 of each treatment period
measure: Area under the plasma insulin concentration curve AUC (0-1h)
timeFrame: At day 1 of each treatment period
measure: Area under the plasma insulin concentration curve AUC (0-2h)
timeFrame: At day 1 of each treatment period
measure: Area under the plasma insulin concentration curve AUC (0-4h)
timeFrame: At day 1 of each treatment period
measure: Area under the plasma insulin concentration curve AUC (0-6h)
timeFrame: At day 1 of each treatment period
measure: Maximum insulin concentration (Cmax)
timeFrame: At day 1 of each treatment period
measure: Time to fraction of total insulin AUC (10%, 20%)
timeFrame: At day 1 of each treatment period
measure: Time to Cmax
timeFrame: At day 1 of each treatment period
measure: Hypoglycaemia and adverse events
timeFrame: from randomization to the end of study
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
Study officials:
References: