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

NCT00283218 | Completed

• 1 other identifier: Asp-BIAsp-2005/0109
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Primary endpoint:

• • 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 Outcomes (3)

• Secondary endpoints:

• 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.

• 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.

Interventions

NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Total insulin demand ≥ 0,5 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).

You may not qualify if:

• 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 \> 2x 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.
• The receipt of any investigational drug within a three month period prior to this trial.

Sponsors & Collaborators

• University of Aarhus: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Dept of Medicine M, Aarhus University Hospital, Nørrebrogade 44

Aarhus, C, 8000, Denmark

Location

Related Publications (4)

• 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.

  PMID: 9314644 BACKGROUND

• 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.

  PMID: 11009049 BACKGROUND

• 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.

  PMID: 1914797 BACKGROUND

• 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.

  PMID: 12027927 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart; insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jens S Christiansen, M.D.

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

  PRINCIPAL INVESTIGATOR

• Tina Parkner, M.D.

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

  STUDY DIRECTOR

• Niels Ejskjaer, M.D.

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

  STUDY DIRECTOR

• Rannveig L Thorisdottir, Stud.med

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 26, 2006
• First Posted: January 27, 2006
• Study Start: January 1, 2006
• Study Completion: August 1, 2006
• Last Updated: August 8, 2006

Record last verified: 2006-08

Locations

DK (1)