Dose-Exposure-Response in Type 1 Diabetes Mellitus

Sanofi18 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus, Type I

Interventions

Insulin glulisineDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 diabetes mellitus Exclusion Criteria: \-

Locations (1)

Sanofi-Aventis

Neuss, Germany

Outcomes

Primary Outcomes

Outcome measures: Glucose infusion rate, insulin concentrations.

Outcome:In T1DM, glulisine, like RHI, displays dose proportionality in exposure over the dose range 0.075 to 0.3 U/kg, which partly only translates into dose proportionality in glucodynamics.

Data from ClinicalTrials.gov

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