Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01076634

Collaborator

(none)

Enrollment

Location

Arms

4.9

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 1	Drug: insulin degludec Drug: insulin degludec	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Trial Investigating the Pharmacodynamic Properties of NN1250 in Subjects With Type 1 Diabetes

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDeg 100 U/mL	Drug: insulin degludec 0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.
Experimental: IDeg 200 U/mL	Drug: insulin degludec 0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.

Arm

Intervention/Treatment

Experimental: IDeg 100 U/mL

Drug: insulin degludec

0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.

Experimental: IDeg 200 U/mL

Drug: insulin degludec

0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.

Outcome Measures

Primary Outcome Measures

Area under the glucose infusion rate curve during one dosing interval at steady-date" [After 8 days of treatment]

Secondary Outcome Measures

Area under the serum Insulin Degludec concentration-time curve [During one dosing interval at steady state]
Area under the serum Insulin Degludec concentration-time curve [From 0 to 24 hours after single dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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