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Insulin Glulisine in Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00310297
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : January 11, 2011
Sponsor:
Information provided by:
Sanofi

Brief Summary:

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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Insulin Glulisine Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : November 2004
Actual Primary Completion Date : December 2004

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Maximum plasma glucose concentration (GLUmax, mmol/L) [ Time Frame: During the Study Conduct ]
  2. Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L) [ Time Frame: during the study conduct ]
  3. Time to GLUmax (Tmax, min) [ Time Frame: during the study conduct ]

Secondary Outcome Measures :
  1. 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) ]
  2. Maximum concentration (Cmax, μIU/mL) [ Time Frame: During the study conduct ]
  3. Adverse events collection [ Time Frame: from the inform consnet signed up to the end of the study ]
  4. Time to maximum concentration (Tmax, min) [ Time Frame: During the study conduct ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310297


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00310297     History of Changes
Other Study ID Numbers: HMR1964A_1505
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: July 2008

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