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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-04-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IDeg

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

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

IGlar U300

Group Type ACTIVE_COMPARATOR

insulin glargine

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No