Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties Between NN5401 and NN1250 and Between NN5401 and Insulin Aspart in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173926
• Other study ID #: NN5401-3857
• Secondary ID: U1111-1114-93482
• Status: Completed
• Phase: Phase 1
• First received: July 30, 2010
• Last updated: November 26, 2013
• Start date: July 2010
• Est. completion date: November 2010

Study information

• Verified date: November 2013
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to compare the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart, IDegAsp) with NN1250 (insulin degludec, IDeg) and insulin aspart (IAsp) in subjects with type 1 diabetes mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months.

• Body mass index 18.0-28.0 kg/m^2 (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 screening

• 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

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec
Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).
• insulin degludec/insulin aspart
Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).
• insulin aspart
Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the glucose infusion rate curve		From 0 to 6 hours after single-dose (only for IDeg and IDegAsp)	No
Primary	Area under the glucose infusion rate curve		From 6 to 24 hours after single-dose (only for IDegAsp and IAsp)	No
Secondary	Area under the serum insulin degludec concentration-time curve		From 0 to 120 hours after single-dose (only for IDeg and IDegAsp)	No
Secondary	Area under the serum insulin aspart concentration-time curve		From 0 to 12 hours after single-dose (only for IDegAsp and IAsp)	No

External Links

•   Clinical Trials at Novo Nordisk