A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 1
Intervention: NN1218 (Drug); insulin aspart (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Nanna Marie Lind, DVM PhD, Study Director, Affiliation: Novo Nordisk
Overall contact:
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
Summary
This trial is conducted in Europe. The purpose of this trial is to compare the
pharmacokinetic properties (the exposure of the trial drug in the body) of different
formulations of NN1218.
Clinical Details
Official title: A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Area under the serum insulin aspart concentration-time curve
Secondary outcome: Area under the serum insulin aspart concentration-time curveMaximum observed serum insulin aspart concentration Time to maximum observed serum insulin aspart concentration
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Type 1 diabetes mellitus for more than 12 months
- Treated with multiple daily insulin injections or continuous subcutaneous insulin
infusion (CSII) for more than 12 months
- Body mass index (BMI) between 18. 0-28. 0 kg/m^2 (both inclusive)
Exclusion Criteria:
- Subjects who has donated any blood or plasma in the past month or more than 500 mL
within 3 months prior to trial start
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent
per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal
nicotine patches during the inpatient period
Locations and Contacts
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
Neuss 41460, Germany; Recruiting
Additional Information
Clinical Trials at Novo Nordisk
Starting date: November 2011
Last updated: November 10, 2011
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