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Investigation of the Impact of Different Application Volumes of Insulin Aspart in Subjects With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
Insulin aspart
Insulin aspart
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 1 Diabetes focused on measuring Insulin aspart, Type 1 diabetes, Glucose clamp, Pharmacodynamics, Pharmacokinetics, Rapid Acting Insulin Analog

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent obtained after being advised of the nature of the study
  • Male or female aged 18-60 years (both inclusive)
  • Type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months
  • Fasting C-peptide < 0.3nmol/L
  • Body mass index 20.0-28.0 kg/m² (both inclusive)
  • HbA1c < 10%

Exclusion Criteria:

  • Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
  • Skin pathology or condition prohibiting needle insertion/insulin administration as judged by the investigator
  • History of bleeding disorder
  • Current participation in another clinical study
  • Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the investigator
  • Smoker (defined as >5 cigarettes/d)
  • Lipodystrophy
  • Current treatment with systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone, herbal products or non-routine vitamins. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months.
  • Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen.

Study Day Exclusion Criteria:

  • Strenuous exercise within the last 24 hours prior to dosing.
  • Non-fasting (i.e. consumption of food or beverages, other than water, later than 22:00 hours the evening before the visit) except if slight intake of rapidly absorbable carbohydrates has been necessary in order to prevent hypoglycaemia.
  • Injection of long-acting insulin (e.g. insulin glargine or insulin detemir) later than 12:00 hours (noon), 2 days before the dosing visit.
  • Injection of NPH insulin or other intermediate-acting insulin products later than 12:00 hours (noon) on the day before the dosing visit.
  • Injection of any short acting insulin (aspart, lispro, glulisine) or more than 6 IU of human insulin between 22:00 hours and 03:00 hours the night before the dosing visit.
  • Injection of any insulin later than 03:00 hours the night before the dosing visit.
  • Infusion of any insulin later than 03:00 hours the night before the dosing visit for subjects using continuous subcutaneous insulin infusion (CSII).
  • Positive result of alcohol breath test.
  • Any medical condition that, in the opinion of the Investigator, could interfere with insulin pharmacokinetics and/or glucose metabolism.

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1 bolus of insulin aspart 18 IU

9 bolus of insulin aspart a 2 IU

Arm Description

Subcutaneous administration of insulin aspart as one bolus of 18 IU at one injection site.

Subcutaneous administration of insulin aspart as 9 separately and simultaneously applied bolus of 2 IU at 9 separate injection sites

Outcomes

Primary Outcome Measures

tmax(ins), time to maximum observed serum insulin aspart concentration

Secondary Outcome Measures

t10%max(ins), time to reach 10% of maximum observed serum insulin aspart concentration

Full Information

First Posted
May 23, 2011
Last Updated
April 19, 2012
Sponsor
Medical University of Graz
Collaborators
European Commission
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1. Study Identification

Unique Protocol Identification Number
NCT01399346
Brief Title
Investigation of the Impact of Different Application Volumes of Insulin Aspart in Subjects With Type 1 Diabetes
Official Title
A Single-center, Randomized, Controlled, 2-period Cross-over, Open-labelled Trial to Evaluate the Impact of Different Application Volumes on Pharmacokinetic and Pharmacodynamic Properties of Insulin Aspart in Subjects With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Graz
Collaborators
European Commission

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Rationale: For the development of a closed loop system, faster insulin absorption after bolus administration could help to reduce the system's delay and thus increase patient safety. It has been shown that regular insulin absorption is faster when injecting insulin with a sprinkler needle (containing holes in the walls and being sealed at the tip). The current study will evaluate the impact of different application volumes on pharmacokinetic and pharmacodynamic properties of rapid acting insulin analogue (insulin aspart). Objective: To compare the pharmacokinetic response (based on the time to maximum observed serum insulin concentration) and pharmacodynamic properties of rapid acting insulin aspart after subcutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in patients with type 1 diabetes. Study design: Monocentric, randomised, controlled, two-arm cross-over intervention study. Population: Twelve type 1 diabetic subjects Intervention: The investigational treatment is the subcutaneous administration of insulin aspart either as one bolus of 18 IU at one injection site or as 9 separately and simultaneously applied bolus of 2 IU each at 9 separate injection sites. Serum and plasma samples to assess pharmacodynamic and pharmacokinetic properties will be taken during an 8-hour clamp experiment. Patients will undergo both investigational treatments in a randomized order; between the two clamp visits there will be a wash-out period of 5-21 days. Main study endpoint: Time to maximum observed serum insulin aspart concentration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Insulin aspart, Type 1 diabetes, Glucose clamp, Pharmacodynamics, Pharmacokinetics, Rapid Acting Insulin Analog

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 bolus of insulin aspart 18 IU
Arm Type
Experimental
Arm Description
Subcutaneous administration of insulin aspart as one bolus of 18 IU at one injection site.
Arm Title
9 bolus of insulin aspart a 2 IU
Arm Type
Experimental
Arm Description
Subcutaneous administration of insulin aspart as 9 separately and simultaneously applied bolus of 2 IU at 9 separate injection sites
Intervention Type
Drug
Intervention Name(s)
Insulin aspart
Intervention Description
Application of 18 IU insulin aspart as one bolus at one injection site
Intervention Type
Drug
Intervention Name(s)
Insulin aspart
Intervention Description
Application of 18 IU insulin aspart as 9 bolus of 2 IU each at nine injection sites
Primary Outcome Measure Information:
Title
tmax(ins), time to maximum observed serum insulin aspart concentration
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
t10%max(ins), time to reach 10% of maximum observed serum insulin aspart concentration
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent obtained after being advised of the nature of the study Male or female aged 18-60 years (both inclusive) Type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months Fasting C-peptide < 0.3nmol/L Body mass index 20.0-28.0 kg/m² (both inclusive) HbA1c < 10% Exclusion Criteria: Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods Skin pathology or condition prohibiting needle insertion/insulin administration as judged by the investigator History of bleeding disorder Current participation in another clinical study Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the investigator Smoker (defined as >5 cigarettes/d) Lipodystrophy Current treatment with systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone, herbal products or non-routine vitamins. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months. Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen. Study Day Exclusion Criteria: Strenuous exercise within the last 24 hours prior to dosing. Non-fasting (i.e. consumption of food or beverages, other than water, later than 22:00 hours the evening before the visit) except if slight intake of rapidly absorbable carbohydrates has been necessary in order to prevent hypoglycaemia. Injection of long-acting insulin (e.g. insulin glargine or insulin detemir) later than 12:00 hours (noon), 2 days before the dosing visit. Injection of NPH insulin or other intermediate-acting insulin products later than 12:00 hours (noon) on the day before the dosing visit. Injection of any short acting insulin (aspart, lispro, glulisine) or more than 6 IU of human insulin between 22:00 hours and 03:00 hours the night before the dosing visit. Injection of any insulin later than 03:00 hours the night before the dosing visit. Infusion of any insulin later than 03:00 hours the night before the dosing visit for subjects using continuous subcutaneous insulin infusion (CSII). Positive result of alcohol breath test. Any medical condition that, in the opinion of the Investigator, could interfere with insulin pharmacokinetics and/or glucose metabolism.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas R Pieber, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Links:
URL
http://www.medunigraz.at
Description
Medical University of Graz

Learn more about this trial

Investigation of the Impact of Different Application Volumes of Insulin Aspart in Subjects With Type 1 Diabetes

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