Insulin Glulisine in Healthy Lean and Obese Subjects

Sanofi

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: Insulin Glulisine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00311077

HMR1964A_1502

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind