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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01269606
First received: January 3, 2011
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 Drug: insulin aspart
Drug: insulin human
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Clearance at steady state (CLss) for IV treatment group [ Time Frame: from 180 min to 240 min ] [ Designated as safety issue: No ]
  • Area under the curve (AUC) for IM treatment group [ Time Frame: from 0 to 480 min after intramuscular injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the curve (AUC) for IM treatment group [ Time Frame: from 0 minutes to infinite time after intramuscular injection ] [ Designated as safety issue: No ]
  • Steady state concentration (Css) for IV treatment group [ Time Frame: from 180 min to 240 min ] [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Time Frame: from screening (visit 1) to follow-up visit (2-21 days after last trial product administration) ] [ Designated as safety issue: No ]
  • Adverse Events (AEs) [ Time Frame: from first trial related activity to follow-up visit (2-21 days after last trial product administration) ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Experimental: Treatment sequence 1 - IV treatment group 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, 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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269606

Locations
Japan
Fukuoka, Japan, 812-0025
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Akane Shimizu Novo Nordisk Pharma Ltd.
Study Director: Kensuke Kanki Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01269606     History of Changes
Other Study ID Numbers: ANA-3877, U1111-1117-1353, Japic No
Study First Received: January 3, 2011
Last Updated: June 15, 2012
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013