NCT00888732

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

April 28, 2011

Status Verified

April 1, 2011

Enrollment Period

1 year

First QC Date

April 27, 2009

Last Update Submit

April 27, 2011

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes

Outcome Measures

Primary Outcomes (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.

    12 hours following a standard test meal (breakfast)

Secondary Outcomes (4)

  • 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

    12 hours following a standard test meal (breakfast)

  • 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

    12 hours following a standard test meal (breakfast)

  • tmaxins: Time to maximum serum insulin aspart/human insulin concentration

    12 hours following a standard test meal (breakfast)

  • 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)

    12 hours following a standard test meal (breakfast)

Study Arms (1)

Insulin therapy

EXPERIMENTAL

Insulin Aspart, Biphasic Insulin Aspart 70 and 50 \& Fast-acting Human Insulin

Drug: Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin

Interventions

Insulin Aspart, BIAsp 70, BIAsp50, Human InsulinDRUG

0.2 U/IU/kg subcutaneous injection, single dose

Also known as: - Insulin Aspart: NovoRapid, - BIAsp 50: NovoMix 50, - BIAsp 70: NovoMix 70, - Human Insulin: Actrapid
Insulin therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 ≥ 0,4 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).

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 \> 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Medicine M, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (7)

  • 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.

    PMID: 19175369BACKGROUND

  • 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: 9314644BACKGROUND

  • 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: 1914797BACKGROUND

  • 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.

    PMID: 11467325BACKGROUND

  • 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: 11009049BACKGROUND

  • 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.

    PMID: 24725803DERIVED

  • 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.

    PMID: 22519735DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Interventions

Insulin AspartInsulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProinsulin

Study Officials

  • Jens S Christiansen, M.D

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 28, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

April 28, 2011

Record last verified: 2011-04

Locations

DK(1)