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

NCT ID: NCT01269606

Last Updated: 2014-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-03-31

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment sequence 1 - IM treatment group

Group Type: EXPERIMENTAL

insulin aspart

Intervention Type: DRUG

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.

Treatment sequence 2 - IM treatment group

Group Type: EXPERIMENTAL

insulin human

Intervention Type: DRUG

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.

Treatment sequence 1 - IV treatment group

Group Type: EXPERIMENTAL

insulin aspart

Intervention Type: DRUG

At the first treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. At the second treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.

Treatment sequence 2 - IV treatment group

Group Type: EXPERIMENTAL

insulin human

Intervention Type: DRUG

At the first treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. At the second treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.

Interventions

insulin aspart

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.

Intervention Type: DRUG

insulin human

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.

Intervention Type: DRUG

insulin aspart

At the first treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. At the second treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.

Intervention Type: DRUG

insulin human

At the first treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. At the second treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Fukuoka, , Japan

Countries

Japan

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

U1111-1117-1353

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-111383

Identifier Type: OTHER

Identifier Source: secondary_id

ANA-3877

Identifier Type: -

Identifier Source: org_study_id