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NCT00290043 Clinical Trial

Glulisine Pre- and Postmeal

Diabetes Mellitus Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00290043
Other study ID # HMR1964A/1008
Secondary ID HMR1964
Status Completed
Phase Phase 1
First received February 9, 2006
Last updated December 3, 2010
Start date December 2001
Est. completion date March 2002

Study information
Verified date December 2010
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Type 1 diabetes mellitus

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Insulin glulisine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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