A Trial Investigating the Within-subject Variability of NN1250 in Subjects With Type 1 Diabetes

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT00961324

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

18.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the variability in the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomised, Single-centre, Double-blind, Parallelgroup, Multiple Dose Trial Comparing the Within-subject Variability of SIBA and Insulin Glargine With Respect to Pharmacodynamic Response at Steady State Conditions in Subjects With Type 1 Diabetes

Actual Study Start Date :

Jul 27, 2009

Actual Primary Completion Date :

Oct 26, 2009

Actual Study Completion Date :

Oct 26, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDeg	Drug: insulin degludec The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days
Experimental: IGlar	Drug: insulin glargine The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days

Arm

Intervention/Treatment

Experimental: IDeg

Drug: insulin degludec

The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days

Experimental: IGlar

Drug: insulin glargine

The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days

Outcome Measures

Primary Outcome Measures

Area under the glucose infusion rate curve during one dosing interval at steady state [0-24 hours (derived on treatment days 6, 9 and 12)]

Secondary Outcome Measures

Area under the NN1250 concentration-time curve during one dosing interval at steady state [0-24 hours (derived on treatment days 6, 9 and 12)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female aged 18-65 years (both inclusive)
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