Glulisine Pre- and Postmeal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00290043
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : December 6, 2010
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Drug: Insulin glulisine Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : December 2001
Study Completion Date : March 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00290043

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

Additional Information: Identifier: NCT00290043     History of Changes
Other Study ID Numbers: HMR1964A/1008
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: December 6, 2010
Last Verified: December 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