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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin glulisine
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014