Dose-Exposure-Response in Type 1 Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type I

Keywords

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Insulin glulisine Euglycaemic clamp Diabetes mellitus Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Insulin glulisine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes mellitus

Exclusion Criteria

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Klaus Rave Dr, med

Role: PRINCIPAL_INVESTIGATOR

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Locations

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Sanofi-Aventis

Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HMR1964

Identifier Type: -

Identifier Source: secondary_id

HMR1964/1019