Dose-Exposure-Response in Type 1 Diabetes Mellitus

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: August 23, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
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 Intervention Phase
Diabetes Mellitus, Type I
Drug: Insulin glulisine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
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)

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 18
Study Start Date: January 2004

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 1 diabetes mellitus

Exclusion Criteria:

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Please refer to this study by its identifier: NCT00368394

Neuss, Germany
Sponsors and Collaborators
Principal Investigator: Klaus Rave Dr, med Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
  More Information

Additional Information:
No publications provided Identifier: NCT00368394     History of Changes
Other Study ID Numbers: HMR1964/1019  HMR1964 
Study First Received: August 23, 2006
Last Updated: August 23, 2006
Health Authority: Germany: Paul-Ehrlich-Institut

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin glulisine
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 07, 2016