Insulin Glulisine in Healthy Lean and Obese Subjects - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00311077

Purpose

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	Intervention	Phase
Diabetes Mellitus	Drug: Insulin Glulisine	Phase I

MedlinePlus related topics: Diabetes Obesity

Drug Information available for: Insulin Insulin glulisine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Pharmacodynamic and Pharmacokinetic Properties of Insulin Glulisine (Apidra) in Comparison to Insulin Lispro (Humalog) in Healthy Lean and Obese Subjects

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To evaluate the serum insulin glulisine concentration and insulin lispro concentration [ Time Frame: During the Study Conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To measure blood glucose [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
To measure glucose infusion rate [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
To measure the serum C-peptide [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Adverse events collection [ Time Frame: from the inform consent signed up to the end of the study ] [ Designated as safety issue: No ]

Study Start Date:	April 2004
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion criteria :

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

Exclusion criteria :

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311077

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Valérie Pilorget, MD

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	HMR1964A/1502
Study First Received:	March 2, 2006
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00311077 History of Changes
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Obesity
Hypoglycemic Agents
Insulin glulisine
Metabolic Diseases
Diabetes Mellitus
Insulin LISPRO

Endocrine System Diseases
Endocrinopathy
Healthy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Insulin glulisine
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009