Glulisine Pre- and Postmeal
Primary Purpose
Diabetes Mellitus Type 1
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Insulin glulisine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 1 focused on measuring Insulin glulisine, Diabetes mellitus Type 1, Postprandial Period, Pharmacokinetics, Glucodynamics
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes mellitus Exclusion Criteria:
Sites / Locations
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00290043
Brief Title
Glulisine Pre- and Postmeal
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 Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 1
Keywords
Insulin glulisine, Diabetes mellitus Type 1, Postprandial Period, Pharmacokinetics, Glucodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Insulin glulisine
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 diabetes mellitus
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Rave, Dr.
Organizational Affiliation
Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.sanofi-aventis.com
Description
Related Info
Learn more about this trial
Glulisine Pre- and Postmeal
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