NCT00290043

Brief Summary

To investigate in type 1 diabetic patients the glucodynamic response to HMR1964 insulin and RHI (HOE31HPR100) injected subcutaneously before and after a standard meal

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2001

Shorter than P25 for phase_1

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

December 1, 2001

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
Last Updated

December 6, 2010

Status Verified

December 1, 2010

First QC Date

February 9, 2006

Last Update Submit

December 3, 2010

Conditions

Diabetes Mellitus Type 1

Keywords

Insulin glulisineDiabetes mellitus Type 1Postprandial PeriodPharmacokineticsGlucodynamics

Outcome Measures

Primary Outcomes (1)

  • Outcome measures: Post-prandial glucose and insulin concentrations. Outcome: In T1DM, insulin glulisine provides a better mimic of the physiological postprandial glucose disposal than RHI.

Interventions

Insulin glulisineDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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.

    Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 9, 2006

First Posted

February 10, 2006

Study Start

December 1, 2001

Study Completion

March 1, 2002

Last Updated

December 6, 2010

Record last verified: 2010-12