A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 in Subjects With Type 1 Diabetes

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-08-31

Brief Summary

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This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) and the pharmacokinetic (exposure of the trial drug in the body) properties of insulin degludec/insulin aspart 15 in subjects with type 1 diabetes.

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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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IDegAsp 15

Group Type EXPERIMENTAL

insulin degludec/insulin aspart 15

Intervention Type DRUG

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW).

placebo

Intervention Type DRUG

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.

IDegAsp

Group Type EXPERIMENTAL

insulin degludec/insulin aspart

Intervention Type DRUG

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW).

placebo

Intervention Type DRUG

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.

IDeg

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.425 U/kg Body Weight (BW).

IAsp

Group Type ACTIVE_COMPARATOR

insulin aspart

Intervention Type DRUG

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.075 U/kg Body Weight (BW).

IDeg + IAsp

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.425 U/kg Body Weight (BW).

insulin aspart

Intervention Type DRUG

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.075 U/kg Body Weight (BW).

Interventions

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insulin degludec/insulin aspart 15

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW).

Intervention Type DRUG

insulin degludec/insulin aspart

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW).

Intervention Type DRUG

insulin degludec

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.425 U/kg Body Weight (BW).

Intervention Type DRUG

insulin aspart

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.075 U/kg Body Weight (BW).

Intervention Type DRUG

placebo

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.

Intervention Type DRUG

Other Intervention Names

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IDegAsp

Eligibility Criteria

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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, use of nicotine substitute products or transdermal nicotine patches during the inpatient period
* Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, condom with spermizide, sexual abstinence or vasectomised partner)

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No