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Glulisine Pre- and Postmeal

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00290043
First received: February 9, 2006
Last updated: December 3, 2010
Last verified: December 2010
  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
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
  Eligibility

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

Inclusion Criteria:

  • Type 1 diabetes mellitus

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290043

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

Additional Information:
No publications provided

ClinicalTrials.gov 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
Pharmacokinetics
Glucodynamics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin glulisine
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014