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NCT00368394 Clinical Trial

Dose-Exposure-Response in Type 1 Diabetes Mellitus

Diabetes Mellitus, Type I Clinical Trial

Official title:
Dose-Exposure-Response Relationship of Insulin Glulisine (HMR1964) in Subjects With Type 1 Diabetes Mellitus Assessed With the Euglycemic Clamp Technique Using the Biostator (TM)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00368394
Other study ID # HMR1964/1019
Secondary ID HMR1964
Status Completed
Phase Phase 1
First received August 23, 2006
Last updated August 23, 2006
Start date January 2004

Study information
Verified date August 2006
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Type 1 diabetes mellitus

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Insulin glulisine

Locations
Country Name City State
Germany Sanofi-Aventis Neuss

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Outcome measures: Glucose infusion rate, insulin concentrations.
Primary 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.
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