Type 1 DiabetesNCT00283218
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70.
A study testing NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70 in people with Type 1 Diabetes, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Aug 2006
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ≥ 0,5 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).
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept of Medicine M, Aarhus University Hospital, Nørrebrogade 44
Aarhus, C, 8000
About this study
Official title: A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70. - A Randomised, Quadruple Cross-Over Trial
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.
Read the 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 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
- Type 1 Diabetes
- Being tested
- NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startJan 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Investigators
- Jens S Christiansen, M.D., Principal investigator, Medicinsk Afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus CTina Parkner, M.D., Study director, Medicinsk Afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus CNiels Ejskjaer, M.D., Study director, Medicinsk afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus CRannveig L Thorisdottir, Stud.med, Study director, Medicinsk afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283218
- Sponsor's protocol ID
- Asp-BIAsp-2005/0109
- Status last verified
- Aug 2006
- First submitted
- 26 Jan 2006
- Last updated
- 8 Aug 2006
- Results posted
- No
Publications
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.
PubMed 9314644Jacobsen 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.
PubMed 11009049Kang 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.
PubMed 1914797Boehm 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.
PubMed 12027927