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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
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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 1 diabetes mellitus

Exclusion Criteria:

  Contacts and Locations
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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: Identifier: NCT00290043     History of Changes
Other Study ID Numbers: HMR1964A/1008
Study First Received: February 9, 2006
Last Updated: December 3, 2010

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, Globin Zinc
Insulin glulisine
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 21, 2017