Dose-Exposure-Response in Type 1 Diabetes Mellitus

Sanofi

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type I

Treatments: Drug: Insulin glulisine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00368394

HMR1964

HMR1964/1019

Details and patient eligibility

About

To investigate the dose-exposure-response relationship of insulin glulisine (HMR1964) after single subcutaneous injections of 0.075, 0.15 and 0.3 U/kg body weight with the euglycaemic clamp technique using the Biostator (TM).

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes mellitus

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind