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A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human Insulin

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities.
  • Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis.
  • Insulin treatment of any regime for more than one year at time of inclusion.
  • Total insulin demand ≥ 0,4 U/IU/kg/24 hrs
  • HbA1c between 7% and 12% (both values included).
  • Age ≥ 18 years.
  • BMI between 18 and 35 kg /m2 (including both values).

Exclusion Criteria:

  • Known or suspected allergy to trial product(s) or related products.
  • Recurrent major hypoglycaemic episodes.
  • Heart: Unstable Angina Pectoris, AMI < 12 months or heart insufficiency classified according to NYHA III-IV
  • Blood Pressure: Severe uncontrolled hypertension with BP > 180/110 mmHg, sitting
  • Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase > 2 x upper reference limit of the local laboratory.
  • Kidneys: Impaired renal function corresponding to serum-creatinin > 150 μmol/l according to the local laboratory.
  • Any disease judged by the investigator to affect the trial.
  • Pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.

Sites / Locations

  • Dept of Medicine M, Aarhus University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insulin therapy

Arm Description

Insulin Aspart, Biphasic Insulin Aspart 70 and 50 & Fast-acting Human Insulin

Outcomes

Primary Outcome Measures

Cmaxglu: Peak plasma glucose following test meal (breakfast). A comparison will be made between fast-acting human insulin vs. IAsp, BIAsp 50 and BIAsp 70, IAsp vs BIAsp 50 and BIAsp 70, BIAsp 50 vs. BIAsp 70.

Secondary Outcome Measures

AUCglu: The area under the plasma glucose concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulins: IAsp, Biphasic insulin aspart 50 and 70 & fast-acting human insulin
AUCins: The area under insulin aspart/human insulin concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulins: IAsp, Biphasic insulin aspart 50 and 70 & fast-acting human insulin
tmaxins: Time to maximum serum insulin aspart/human insulin concentration
Serum GH, total IGF-I, IGF-I bioactivity, IGFBP-1, IGFBP-2, binary complex of IGF-I, IGFBP-3 and the acid-labile subunit (ALS)

Full Information

First Posted
April 27, 2009
Last Updated
April 27, 2011
Sponsor
University of Aarhus
Collaborators
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00888732
Brief Title
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human Insulin
Official Title
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 70 and 50 & Fast-acting Human Insulin in Patients With Type 1 Diabetes, A Randomised, Quadruple Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus
Collaborators
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The hypothesis is that an optimal formulation of fast acting and intermediary acting insulin analogues will improve post prandial glycaemic control in patients with type 1 diabetes
Detailed Description
This trial is a single centre, open-label, randomised 4 period cross-over trial, comparing the pk and pd profiles of IAsp, BIAsp 50, BIAsp 70 and Fast-acting Human Insulin after a standard test meal in subjects with type 1 diabetes. The profiles will be derived over a 12-hour period after subcutaneous injection in the abdominal region with a single dose of IAsp, BIAsp 50, BIAsp 70 or Fast-acting Human Insulin at a test meal. The trial consists of a screening period of 4-21 days and 4 treatment visits.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin therapy
Arm Type
Experimental
Arm Description
Insulin Aspart, Biphasic Insulin Aspart 70 and 50 & Fast-acting Human Insulin
Intervention Type
Drug
Intervention Name(s)
Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin
Other Intervention Name(s)
- Insulin Aspart: NovoRapid, - BIAsp 50: NovoMix 50, - BIAsp 70: NovoMix 70, - Human Insulin: Actrapid
Intervention Description
0.2 U/IU/kg subcutaneous injection, single dose
Primary Outcome Measure Information:
Title
Cmaxglu: Peak plasma glucose following test meal (breakfast). A comparison will be made between fast-acting human insulin vs. IAsp, BIAsp 50 and BIAsp 70, IAsp vs BIAsp 50 and BIAsp 70, BIAsp 50 vs. BIAsp 70.
Time Frame
12 hours following a standard test meal (breakfast)
Secondary Outcome Measure Information:
Title
AUCglu: The area under the plasma glucose concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulins: IAsp, Biphasic insulin aspart 50 and 70 & fast-acting human insulin
Time Frame
12 hours following a standard test meal (breakfast)
Title
AUCins: The area under insulin aspart/human insulin concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulins: IAsp, Biphasic insulin aspart 50 and 70 & fast-acting human insulin
Time Frame
12 hours following a standard test meal (breakfast)
Title
tmaxins: Time to maximum serum insulin aspart/human insulin concentration
Time Frame
12 hours following a standard test meal (breakfast)
Title
Serum GH, total IGF-I, IGF-I bioactivity, IGFBP-1, IGFBP-2, binary complex of IGF-I, IGFBP-3 and the acid-labile subunit (ALS)
Time Frame
12 hours following a standard test meal (breakfast)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent obtained before any trial-related activities. Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis. Insulin treatment of any regime for more than one year at time of inclusion. Total insulin demand ≥ 0,4 U/IU/kg/24 hrs HbA1c between 7% and 12% (both values included). Age ≥ 18 years. BMI between 18 and 35 kg /m2 (including both values). Exclusion Criteria: Known or suspected allergy to trial product(s) or related products. Recurrent major hypoglycaemic episodes. Heart: Unstable Angina Pectoris, AMI < 12 months or heart insufficiency classified according to NYHA III-IV Blood Pressure: Severe uncontrolled hypertension with BP > 180/110 mmHg, sitting Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase > 2 x upper reference limit of the local laboratory. Kidneys: Impaired renal function corresponding to serum-creatinin > 150 μmol/l according to the local laboratory. Any disease judged by the investigator to affect the trial. Pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens S Christiansen, M.D
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Medicine M, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
19175369
Citation
Thorisdottir RL, Parkner T, Chen JW, Ejskjaer N, Christiansen JS. A comparison of pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30, 50, 70 and pure insulin aspart: a randomized, quadruple crossover study. Basic Clin Pharmacol Toxicol. 2009 Mar;104(3):216-21. doi: 10.1111/j.1742-7843.2008.00355.x. Epub 2009 Jan 20.
Results Reference
background
PubMed Identifier
9314644
Citation
Weyer C, Heise T, Heinemann L. Insulin aspart in a 30/70 premixed formulation. Pharmacodynamic properties of a rapid-acting insulin analog in stable mixture. Diabetes Care. 1997 Oct;20(10):1612-4. doi: 10.2337/diacare.20.10.1612.
Results Reference
background
PubMed Identifier
1914797
Citation
Kang S, Creagh FM, Peters JR, Brange J, Volund A, Owens DR. Comparison of subcutaneous soluble human insulin and insulin analogues (AspB9, GluB27; AspB10; AspB28) on meal-related plasma glucose excursions in type I diabetic subjects. Diabetes Care. 1991 Jul;14(7):571-7. doi: 10.2337/diacare.14.7.571.
Results Reference
background
PubMed Identifier
11467325
Citation
Thrailkill KM. Insulin-like growth factor-I in diabetes mellitus: its physiology, metabolic effects, and potential clinical utility. Diabetes Technol Ther. 2000 Spring;2(1):69-80. doi: 10.1089/152091599316775.
Results Reference
background
PubMed Identifier
11009049
Citation
Jacobsen LV, Sogaard B, Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Eur J Clin Pharmacol. 2000 Aug;56(5):399-403. doi: 10.1007/s002280000159.
Results Reference
background
PubMed Identifier
24725803
Citation
Ma Z, Christiansen JS, Laursen T, Wu C, Lauritzen T, Parkner T, Frystyk J. Effects of human insulin and insulin aspart preparations on levels of IGF-I, IGFBPs and IGF bioactivity in patients with type 1 diabetes. BMC Endocr Disord. 2014 Apr 11;14:35. doi: 10.1186/1472-6823-14-35.
Results Reference
derived
PubMed Identifier
22519735
Citation
Ma Z, Parkner T, Frystyk J, Laursen T, Lauritzen T, Christiansen JS. A comparison of pharmacokinetics and pharmacodynamics of insulin aspart, biphasic insulin aspart 70, biphasic insulin aspart 50, and human insulin: a randomized, quadruple crossover study. Diabetes Technol Ther. 2012 Jul;14(7):589-95. doi: 10.1089/dia.2011.0299. Epub 2012 Apr 20.
Results Reference
derived
Links:
URL
http://www.aarhussygehus.dk
Description
Click here for more information about trial site (Danish version only)

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A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human Insulin

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