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Dose-Exposure-Response in Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00368394
First received: August 23, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

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

Inclusion Criteria:

  • Type 1 diabetes mellitus

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov 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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin glulisine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013