Insulin Glulisine in Healthy Lean and Obese Subjects

NCT ID: NCT00311077

Last Updated: 2009-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Insulin Glulisine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Systemic concomitant medication

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Valérie Pilorget, MD

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

HMR1964A_1502

Identifier Type: -

Identifier Source: org_study_id