NCT00368394

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
Last Updated

August 24, 2006

Status Verified

August 1, 2006

First QC Date

August 23, 2006

Last Update Submit

August 23, 2006

Conditions

Diabetes Mellitus, Type I

Keywords

Insulin glulisineEuglycaemic clampDiabetes mellitus Type 1

Outcome Measures

Primary Outcomes (2)

  • 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.

Interventions

Insulin glulisineDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type 1 diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Neuss, Germany

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Klaus Rave Dr, med

    Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 23, 2006

First Posted

August 24, 2006

Study Start

January 1, 2004

Last Updated

August 24, 2006

Record last verified: 2006-08

Locations

DE(1)