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Insulin Glulisine in Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00310297
First received: March 2, 2006
Last updated: January 10, 2011
Last verified: July 2008
History of Changes
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Insulin Glulisine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Maximum plasma glucose concentration (GLUmax, mmol/L) [ Time Frame: During the Study Conduct ] [ Designated as safety issue: No ]
  • Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L) [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
  • Time to GLUmax (Tmax, min) [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the insulin concentration-time curve after injection(μIU.min/mL) [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax, μIU/mL) [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Adverse events collection [ Time Frame: from the inform consnet signed up to the end of the study ] [ Designated as safety issue: No ]
  • Time to maximum concentration (Tmax, min) [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Study Start Date: November 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310297

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Valérie Pilorget, MD Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00310297     History of Changes
Other Study ID Numbers: HMR1964A_1505
Study First Received: March 2, 2006
Last Updated: January 10, 2011
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin glulisine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013