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

NCT01159353 | Completed Phase 1

• 2 other identifiers: APIDR_C_011602006-005536-24
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Area under the plasma glucose concentration curve (AUC) between 0 and 1 hour after insulin injection AUC(0-1h)

  At day 1 of each treatment period

Secondary Outcomes (16)

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

  At day 1 of each treatment period

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

  At day 1 of each treatment period

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

  At day 1 of each treatment period

• Delta plasma glucose at 1h after standard meal

  At day 1 of each treatment period

• Maximum glucose concentration (GLU max)

  At day 1 of each treatment period

Study Arms (2)

insulin glulisine + insulin aspart

EXPERIMENTAL

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

Drug: Insulin glulisine; Drug: Insulin aspart

insulin aspart + insulin glulisine

EXPERIMENTAL

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

Drug: Insulin glulisine; Drug: Insulin aspart

Interventions

Insulin glulisine DRUG

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

insulin aspart + insulin glulisine; insulin glulisine + insulin aspart

Insulin aspart DRUG

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

insulin aspart + insulin glulisine; insulin glulisine + insulin aspart

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Paris, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin glulisine; Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 9, 2010
• Study Start: September 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: July 16, 2010

Record last verified: 2010-07

Locations

FR (1)