A Trial Investigating NN1218 in Subjects With Type 1 Diabetes

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: NN1218; Drug: insulin aspart

• Registration Number: NCT01121289
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-12
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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/m2 (both inclusive)

Exclusion Criteria

• Subject 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NN1218, formulation B (high)	NN1218	-
NN1218, formulation C	NN1218	-
NN1218, formulation D	NN1218	-
insulin aspart	insulin aspart	-
NN1218, formulation A	NN1218	-
NN1218, formulation B	NN1218	-

Primary Outcome Measures

Name	Time	Method
Area under the serum NN1218 concentration-time curve	From 0-1 hours

Secondary Outcome Measures

Name	Time	Method
Area under the serum NN1218 concentration-time curve	From 0-10 hours