Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT02536859

Collaborator

(none)

Enrollment

Location

Arms

7.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec and insulin glargine 300 U/mL at steady-state conditions in subjects with type 1 diabetes mellitus.

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 :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomised, Single-centre, Double-blind, Two-period Cross-over, Multiple Dose Trial Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus

Actual Study Start Date :

Aug 31, 2015

Actual Primary Completion Date :

Apr 14, 2016

Actual Study Completion Date :

Apr 14, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDeg	Drug: insulin degludec Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.
Active Comparator: IGlar U300	Drug: insulin glargine Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.

Arm

Intervention/Treatment

Experimental: IDeg

Drug: insulin degludec

Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.

Active Comparator: IGlar U300

Drug: insulin glargine

Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.

Outcome Measures

Primary Outcome Measures

Area under the glucose infusion rate curve [During one dosing interval (0-24h) at steady-state. At day 6, 9 and 12]

Secondary Outcome Measures

Area under the glucose infusion rate curve [During one dosing interval at steady state.At day 6, 9 and 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
Body mass index 18.5-29.0 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)who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the in-patient period