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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
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)

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   (Adult)
Sexes 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: Identifier: NCT00368394     History of Changes
Other Study ID Numbers: HMR1964/1019
Study First Received: August 23, 2006
Last Updated: August 23, 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
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on August 22, 2017