A Trial Investigating NN1218 in Subjects With Type 1 and Type 2 Diabetes

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: Faster-acting insulin aspart; Drug: insulin aspart

• Registration Number: NCT01121276
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 and type 2 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: 2010-09
• Study Completion: 2010-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Type 1 or type 2 diabetes mellitus for more than 12 months
• Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer for subjects with type 1 diabetes and for 3 months or longer for subjects with type 2 diabetes
• Body Mass Index (BMI) between 18.0-32.0 kg/m2 (both inclusive)

Exclusion Criteria

• Surgery or trauma with significant blood loss (more than 500 mL) within the last 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	Faster-acting insulin aspart	-
NN1218, formulation C	Faster-acting insulin aspart	-
insulin aspart	insulin aspart	-
NN1218, formulation D	Faster-acting insulin aspart	-
NN1218, formulation A	Faster-acting insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Area under the blood glucose concentration-time curve	from 0-2 hours

Secondary Outcome Measures

Name	Time	Method
Area under the blood glucose concentration-time curve	from 0-6 hours

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Chula Vista, California, United States