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Dose-Exposure-Response in Type 1 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type I

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Insulin glulisine

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type I focused on measuring Insulin glulisine, Euglycaemic clamp, Diabetes mellitus Type 1

Eligibility Criteria

18 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Type 1 diabetes mellitus Exclusion Criteria: -

Sites / Locations

Sanofi-Aventis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00368394

First Posted

August 23, 2006

Last Updated

August 23, 2006

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00368394

Brief Title

Dose-Exposure-Response in Type 1 Diabetes Mellitus

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2006

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type I

Keywords

Insulin glulisine, Euglycaemic clamp, Diabetes mellitus Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Single

Allocation

Randomized

Enrollment

18 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Insulin glulisine

Primary Outcome Measure Information:

Title

Outcome measures: Glucose infusion rate, insulin concentrations.

Title

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.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 1 diabetes mellitus Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Klaus Rave Dr, med

Organizational Affiliation

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sanofi-Aventis

City

Neuss

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.sanofi-aventis.com

Description

Related Info

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Dose-Exposure-Response in Type 1 Diabetes Mellitus

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