Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes
This study has been completed.
Information provided by (Responsible Party):
First received: February 24, 2010
Last updated: June 29, 2012
Last verified: June 2012
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 formulations in subjects with type 1 diabetes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Trial Investigating the Pharmacodynamic Properties of NN1250 in Subjects With Type 1 Diabetes|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- AUC area under the glucose infusion rate curve during one dosing interval at steady-date" after [ Time Frame: after 8 days of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- AUC area under the serum NN1250 concentration-time curve [ Time Frame: during one dosing interval at steady state ] [ Designated as safety issue: No ]
- AUC area under the serum NN1250 concentration-time curve [ Time Frame: from 0 to 24 hours after single dose ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
NN1250, 0.4 U/kg body weight, formulation 1. Injected subcutaneously (under the skin) once daily for 8 days.
NN1250, 0.4 U/kg body weight, formulation 2. Injected subcutaneously (under the skin) once daily for 8 days.
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