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Completed

NCT Number: NCT01269606

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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fukuoka, 812-0025, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin aspart

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.

insulin human

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.

Primary outcomes

  1. Clearance at steady state (CLss) for IV treatment group

    Time frame: from 180 min to 240 min

  2. Area under the curve (AUC) for IM treatment group

    Time frame: from 0 to 480 min after intramuscular injection

Secondary outcomes

  1. Area under the curve (AUC) for IM treatment group

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

  2. Steady state concentration (Css) for IV treatment group

    Time frame: from 180 min to 240 min

  3. Hypoglycaemic episodes

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

  4. Adverse Events (AEs)

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 4, 2011
Registry last updated
Jun 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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