Dose-Exposure-Response in Type 1 Diabetes Mellitus - Tabular View

Tracking Information

First Received Date ^ICMJE

August 23, 2006

Last Updated Date

August 23, 2006

Start Date ^ICMJE

January 2004

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Dose-Exposure-Response in Type 1 Diabetes Mellitus

Official Title ^ICMJE

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)

Brief 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).

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Diabetes Mellitus, Type I

Intervention ^ICMJE

Drug: Insulin glulisine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 1 diabetes mellitus

Exclusion Criteria:

Gender

Male

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Expanded Access Status

Administrative Information

NCT ID ^ICMJE

NCT00368394

Responsible Party

Study ID Numbers ^ICMJE

HMR1964/1019, HMR1964

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Klaus Rave Dr, med

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Information Provided By

Sanofi-Aventis

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP