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Glulisine Pre- and Postmeal

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00290043
First Posted: February 10, 2006
Last Update Posted: December 6, 2010
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.
Information provided by:
Sanofi
  Purpose
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: 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

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
  Eligibility

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
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus

Exclusion Criteria:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00290043


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00290043     History of Changes
Other Study ID Numbers: HMR1964A/1008
HMR1964
First Submitted: February 9, 2006
First Posted: February 10, 2006
Last Update Posted: December 6, 2010
Last Verified: December 2010

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

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
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs