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

A Trial Comparing the Pharmacokinetic Properties of Insulin Aspart With Fast-acting Insulin Human Following Intravenous Infusion or Intramuscular Injection in Japanese Subjects With Type 1 Diabetes Mellitus

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 Overview

• Status: Completed
• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: insulin aspart; Drug: insulin aspart; Drug: insulin human; Drug: insulin human

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment sequence 1 - IM treatment group	Drug: 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.; 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.
Experimental: Treatment sequence 2 - IM treatment group	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.; 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.
Experimental: Treatment sequence 1 - IV treatment group	Drug: 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.; 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.
Experimental: Treatment sequence 2 - IV treatment group	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clearance at steady state (CLss) for IV treatment group	from 180 min to 240 min
Area under the curve (AUC) for IM treatment group	from 0 to 480 min after intramuscular injection

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the curve (AUC) for IM treatment group	from 0 minutes to infinite time after intramuscular injection
Steady state concentration (Css) for IV treatment group	from 180 min to 240 min
Hypoglycaemic episodes	from screening (visit 1) to follow-up visit (2-21 days after last trial product administration)
Adverse Events (AEs)	from first trial related activity to follow-up visit (2-21 days after last trial product administration)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: January 3, 2011
• First Submitted That Met QC Criteria: January 3, 2011
• First Posted (Estimate): January 4, 2011

Study Record Updates

• Last Update Posted (Estimate): June 16, 2014
• Last Update Submitted That Met QC Criteria: June 13, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
• Other Study ID Numbers: ANA-3877; U1111-1117-1353 (Other Identifier: WHO); JapicCTI-111383 (Other Identifier: JAPIC)