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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
insulin aspart
insulin human
insulin aspart
insulin human
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Treatment sequence 1 - IM treatment group

Treatment sequence 2 - IM treatment group

Treatment sequence 1 - IV treatment group

Treatment sequence 2 - IV treatment group

Arm Description

Outcomes

Primary Outcome Measures

Clearance at steady state (CLss) for IV treatment group
Area under the curve (AUC) for IM treatment group

Secondary Outcome Measures

Area under the curve (AUC) for IM treatment group
Steady state concentration (Css) for IV treatment group
Hypoglycaemic episodes
Adverse Events (AEs)

Full Information

First Posted
January 3, 2011
Last Updated
June 13, 2014
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01269606
Brief Title
Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment sequence 1 - IM treatment group
Arm Type
Experimental
Arm Title
Treatment sequence 2 - IM treatment group
Arm Type
Experimental
Arm Title
Treatment sequence 1 - IV treatment group
Arm Type
Experimental
Arm Title
Treatment sequence 2 - IV treatment group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
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
Intervention Name(s)
insulin human
Intervention Description
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
Intervention Name(s)
insulin aspart
Intervention Description
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
Intervention Name(s)
insulin human
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clearance at steady state (CLss) for IV treatment group
Time Frame
from 180 min to 240 min
Title
Area under the curve (AUC) for IM treatment group
Time Frame
from 0 to 480 min after intramuscular injection
Secondary Outcome Measure Information:
Title
Area under the curve (AUC) for IM treatment group
Time Frame
from 0 minutes to infinite time after intramuscular injection
Title
Steady state concentration (Css) for IV treatment group
Time Frame
from 180 min to 240 min
Title
Hypoglycaemic episodes
Time Frame
from screening (visit 1) to follow-up visit (2-21 days after last trial product administration)
Title
Adverse Events (AEs)
Time Frame
from first trial related activity to follow-up visit (2-21 days after last trial product administration)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
City
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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