Dose-Exposure-Response in Type 1 Diabetes Mellitus

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00368394

Enrollment

Registered

2006-08-24

Start date

2004-01-31

Completion date

Unknown

Last updated

2006-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type I

Keywords

Insulin glulisine, Euglycaemic clamp, Diabetes mellitus Type 1

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).

Interventions

DRUGInsulin glulisine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Type 1 diabetes mellitus

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026