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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
Sponsor:
Information provided by:
Sanofi

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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type I Drug: Insulin glulisine Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources




Primary Outcome Measures :
  1. Outcome measures: Glucose infusion rate, insulin concentrations.
  2. 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.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus

Exclusion Criteria:


Information from the National Library of Medicine

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


Locations
Germany
Sanofi-Aventis
Neuss, Germany
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Klaus Rave Dr, med Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Additional Information:
ClinicalTrials.gov Identifier: NCT00368394     History of Changes
Other Study ID Numbers: HMR1964/1019
HMR1964
First Posted: August 24, 2006    Key Record Dates
Last Update Posted: August 24, 2006
Last Verified: August 2006

Keywords provided by Sanofi:
Insulin glulisine
Euglycaemic clamp
Diabetes mellitus Type 1

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin glulisine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs