A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70.

Type 1 Diabetes Clinical Trial

Official title:

A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70. - A Randomised, Quadruple Cross-Over Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283218
• Other study ID #: Asp-BIAsp-2005/0109
• Status: Completed
• Phase: N/A
• First received: January 26, 2006
• Last updated: August 7, 2006
• Start date: January 2006
• Est. completion date: August 2006

Study information

• Verified date: August 2006
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

OBJECTIVE:

The objective is to describe pharmacodynamic (PD) and pharmacokinetic (PK) profiles of Insulin Aspart (IAsp), Biphasic Insulin Aspart (BIAsp) 30, 50 and 70 for a period of 12 hours following a standard test meal on four days respectively in subjects with type 1 diabetes.

Description:

This trial is a single centre, open-label, randomised 4 period cross-over trial, comparing the pk and pd profiles of IAsp, BIAsp 30, BIAsp 50 and BIAsp 70 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 30, BIAsp 50 or BIAsp 70 at a test meal. The trial consists of a screening period of 4-21 days and 4 treatment visits

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Informed consent obtained before any trial-related activities.

2. Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis.

3. Insulin treatment of any regime for more than one year at time of inclusion.

4. Total insulin demand = 0,5 IU/kg/24 hrs

5. HbA1c between 7% and 12 % (both values included).

6. Age = 18 years.

7. BMI between 18 and 35 kg /m2 (including both values).

Exclusion Criteria:

1. Known or suspected allergy to trial product(s) or related products.

2. Recurrent major hypoglycaemic episodes.

3. Heart: Unstable Angina Pectoris, AMI < 12 months or heart insufficiency classified according to NYHA III-IV

4. Blood Pressure: Severe uncontrolled hypertension with BP > 180/110 mmHg, sitting

5. Liver: Impaired hepatic function corresponding to serum-ALAT or –basic phosphatase > 2x upper reference limit of the local laboratory.

6. Kidneys: Impaired renal function corresponding to serum-creatinin > 150 µmol/l according to the local laboratory.

7. Any disease judged by the investigator to affect the trial.

8. 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.

9. The receipt of any investigational drug within a three month period prior to this trial.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Drug:
• NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70

Locations

Country	Name	City	State
Denmark	Dept of Medicine M, Aarhus University Hospital, Nørrebrogade 44	Aarhus	C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients. Diabet Med. 2002 May;19(5):393-9. Erratum in: Diabet Med. 2002 Sep;19(9):797.. — View Citation

Jacobsen LV, Søgaard 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. — View Citation

Kang S, Creagh FM, Peters JR, Brange J, Vølund 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint:
Primary	• Cmaxglu: Peak plasma glucose following test meal (breakfast). A comparison will be made between BIAsp 50 vs BIAsp 70, BIAsp 30 vs BIAsp 70, BIAsp 30 vs BIAsp 50 and IAsp vs BIAsp 30, 50 and 70.
Secondary	Secondary endpoints:
Secondary	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 insulin aspart preparation: IAsp (NovoRapid®), Biphasic insulin aspart 30, 50 and 70.
Secondary	AUCins: The area under insulin aspart 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 insulin aspart preparation: IAsp (NovoRapid®), Biphasic insulin aspart 30, 50 and 70.