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Diabetes Mellitus, Type 1Phase 3NCT00888732

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

A Phase 3 study testing Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin in people with Diabetes Mellitus, Type 1, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Diabetes Mellitus, Type 1
What is being tested?
Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteDenmark
Study dates
Jun 2009to Jun 2010
Phase
Phase 3
Are there results?
None posted in the registry

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 ≥ 0,4 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).

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 > 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Dept of Medicine M, Aarhus University Hospital

    Aarhus, 8000

Other trials in Denmark

About this study

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

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 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 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.

Being tested
Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin
Keywords
Diabetes
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin Aspart, BIAsp 70, BIAsp50, Human InsulinDrug

    Also called - Insulin Aspart: NovoRapid, - BIAsp 50: NovoMix 50, - BIAsp 70: NovoMix 70, - Human Insulin: Actrapid

    0.2 U/IU/kg subcutaneous injection, single dose

Study groups in NCT00888732
Study groupRoleWhat they receive
Insulin therapyExperimentalInsulin Aspart, Biphasic Insulin Aspart 70 and 50 \& Fast-acting Human Insulin
Receives: Drug: Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 hours following a standard test meal (breakfast)

Secondary outcomes (4)

  1. 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

    Measured: 12 hours following a standard test meal (breakfast)

  2. 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

    Measured: 12 hours following a standard test meal (breakfast)

  3. tmaxins: Time to maximum serum insulin aspart/human insulin concentration

    Measured: 12 hours following a standard test meal (breakfast)

  4. 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)

    Measured: 12 hours following a standard test meal (breakfast)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00888732
Sponsor's protocol ID
Asp-BIAsp-HI-2008
Other IDs
2008-007176-22, 2008
Status last verified
Apr 2011
First submitted
27 Apr 2009
Last updated
28 Apr 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19175369

  • 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 9314644

  • 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.

    PubMed 1914797

  • 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.

    PubMed 11467325

  • 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.

    PubMed 11009049

  • 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.

    PubMed 24725803

  • 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.

    PubMed 22519735

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin in people with Diabetes Mellitus, Type 1, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00888732, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2011.

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