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

NCT ID: NCT00283218

Last Updated: 2006-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Principal Investigators

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Jens S Christiansen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medicinsk Afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C

Tina Parkner, M.D.

Role: STUDY_DIRECTOR

Medicinsk Afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C

Niels Ejskjaer, M.D.

Role: STUDY_DIRECTOR

Medicinsk afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C

Rannveig L Thorisdottir, Stud.med

Role: STUDY_DIRECTOR

Medicinsk afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C

Locations

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Dept of Medicine M, Aarhus University Hospital, Nørrebrogade 44

Aarhus, C, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 9314644 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11009049 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1914797 (View on PubMed)

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. doi: 10.1046/j.1464-5491.2002.00733.x.

Reference Type BACKGROUND
PMID: 12027927 (View on PubMed)

Other Identifiers

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Asp-BIAsp-2005/0109

Identifier Type: -

Identifier Source: org_study_id