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Insulin Glulisine in Healthy Lean and Obese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00311077
Recruitment Status : Completed
First Posted : April 5, 2006
Last Update Posted : December 7, 2009
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Brief Summary:

Primary objective

  • To investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration of two different doses (low dose, 0.2 IU/kg and high dose, 0.4 IU/kg) of insulin glulisine across healthy subjects in 4 different BMI-classes (lean, overweight, moderately obese, severely obese), using the euglycemic clamp technique with the Biostator™.

Secondary objective

  • To investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous administration of insulin glulisine in comparison to insulin lispro and to investigate the safety and tolerability after subcutaneous administration of insulin glulisine in comparison to insulin lispro.

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

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pharmacodynamic and Pharmacokinetic Properties of Insulin Glulisine (Apidra) in Comparison to Insulin Lispro (Humalog) in Healthy Lean and Obese Subjects
Study Start Date : April 2004
Actual Primary Completion Date : October 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To evaluate the serum insulin glulisine concentration and insulin lispro concentration [ Time Frame: During the Study Conduct ]

Secondary Outcome Measures :
  1. To measure blood glucose [ Time Frame: During the study conduct ]
  2. To measure glucose infusion rate [ Time Frame: During the study conduct ]
  3. To measure the serum C-peptide [ Time Frame: During the study conduct ]
  4. Adverse events collection [ Time Frame: from the inform consent signed up to the end of the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria :

  • Normal HbA1c
  • Women have to either be postmenopausal, surgically sterilized, or not pregnant and using adequate contraception.

Exclusion criteria :

  • Systemic concomitant medication

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 identifier (NCT number): NCT00311077

Sponsors and Collaborators
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Study Director: Valérie Pilorget, MD Sanofi
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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00311077    
Other Study ID Numbers: HMR1964A_1502
First Posted: April 5, 2006    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009
Additional relevant MeSH terms:
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Insulin glulisine
Hypoglycemic Agents
Physiological Effects of Drugs