Insulin Glulisine in Type 2 Diabetes Mellitus

A Randomized, Open Label, Two-arm, Cross-over Design Study to Compare the Pharmacodynamics and Pharmacokinetics of Insulin Glulisine and Insulin Lispro in Obese Patients With Type 2 Diabetes.

Primary objective:

To compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects with type 2 diabetes.

Secondary objectives:

• To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese subjects with type 2 diabetes, injected subcutaneously before three standard meals during a 12-hour day.
• The safety of insulin glulisine, the relationship of the pharmacodynamics and pharmacokinetics with skin thickness and C-peptide, non-esterified fatty acid, triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Insulin Glulisine

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria :

• Type 2 diabetes mellitus
• Body mass index (BMI) between 35 and 40 kg/m2
• HbA1c ≤10%
• Plasma C-peptide levels ≥0.1 nmol/L.
• Female subjects have to either be postmenopausal, surgically sterilized, or not pregnant and using approved methods of contraception.

Exclusion criteria :

• Type 1 diabetes mellitus, as defined by the World Health Organization
• Subjects currently taking any insulin
• History of hypoglycaemic unawareness
• Injection site skin thickness < or = 8 mm

• Contra-indications from

  • The medical history and physical examination
  • Laboratory tests (haematology, clinical chemistry, and urinalysis by dipstick)
  • Blood pressure and pulse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma glucose concentration (GLUmax, mmol/L)	During the Study Conduct
Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L)	during the study conduct
Time to GLUmax (Tmax, min)	during the study conduct

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the insulin concentration-time curve after injection(μIU.min/mL)	between 0 h and 1 h (AUC0-1h), 0 h and 1.5 h (AUC0-1.5h), 0 h and 2 h (AUC0-2h) and 0 h and 4 h (AUC0-4h)
Maximum concentration (Cmax, μIU/mL)	During the study conduct
Adverse events collection	from the inform consnet signed up to the end of the study
Time to maximum concentration (Tmax, min)	During the study conduct

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: March 2, 2006
• First Submitted That Met QC Criteria: March 31, 2006
• First Posted (Estimate): April 3, 2006

Study Record Updates

• Last Update Posted (Estimate): January 11, 2011
• Last Update Submitted That Met QC Criteria: January 10, 2011
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin glulisine
• Other Study ID Numbers: HMR1964A_1505