Glulisine Pre- and Postmeal

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: February 9, 2006
Last updated: December 3, 2010
Last verified: December 2010

To investigate in type 1 diabetic patients the glucodynamic response to HMR1964 insulin and RHI (HOE31HPR100) injected subcutaneously before and after a standard meal

Condition Intervention Phase
Diabetes Mellitus Type 1
Drug: Insulin glulisine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glucodynamic Response to Pre- and Postmeal Subcutaneous Injection of 0.15 IU/kg HMR1964 Insulin and RHI in Type 1 Diabetic Subjects in an Open, Randomized, Four-way Crossover Study

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Outcome measures: Post-prandial glucose and insulin concentrations. Outcome: In T1DM, insulin glulisine provides a better mimic of the physiological postprandial glucose disposal than RHI.

Estimated Enrollment: 20
Study Start Date: December 2001
Estimated Study Completion Date: March 2002

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 1 diabetes mellitus

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its identifier: NCT00290043

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

Additional Information:
No publications provided Identifier: NCT00290043     History of Changes
Other Study ID Numbers: HMR1964A/1008, HMR1964
Study First Received: February 9, 2006
Last Updated: December 3, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Sanofi:
Insulin glulisine
Diabetes mellitus Type 1
Postprandial Period

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 23, 2014