Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes

Novo Nordisk A/S13 enrolled

Overview

This trial is conducted in Japan. The aim of the trial is to compare pharmacokinetics (at which rate the body eliminates the substance from the body) of insulin aspart with fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection in Japanese subjects with type 1 diabetes mellitus.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin aspartDRUG

At the first treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. At the second treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.

insulin humanDRUG

At the first treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered.At the second treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.

insulin aspartDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * Treated with multiple daily insulin injections for at least 12 months * Current daily basal insulin requirement above or equal to 0.3 U/kg/day * Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0% * Body Mass Index (BMI) 18.0-28.0 kg/m\^2 Exclusion Criteria: * Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start (screening) * Surgery or trauma with significant blood loss (more than 500 mL) within 3 months prior to trial start (screening) * Subject who smokes more than 10 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

Locations (1)

Unnamed facility

Fukuoka, Japan

Outcomes

Primary Outcomes

Clearance at steady state (CLss) for IV treatment group

Time frame: from 180 min to 240 min

Area under the curve (AUC) for IM treatment group

Time frame: from 0 to 480 min after intramuscular injection

Secondary Outcomes

Area under the curve (AUC) for IM treatment group

Time frame: from 0 minutes to infinite time after intramuscular injection

Steady state concentration (Css) for IV treatment group

Time frame: from 180 min to 240 min

Hypoglycaemic episodes

Time frame: from screening (visit 1) to follow-up visit (2-21 days after last trial product administration)

Adverse Events (AEs)

Time frame: from first trial related activity to follow-up visit (2-21 days after last trial product administration)

Data from ClinicalTrials.gov

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