Dose-Exposure-Response in Type 1 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT00368394|
Recruitment Status : Completed
First Posted : August 24, 2006
Last Update Posted : August 24, 2006
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type I||Drug: Insulin glulisine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|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 Start Date :||January 2004|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368394
|Principal Investigator:||Klaus Rave Dr, med||Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany|