E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes mellitus |
Type 2 diabetes mellitus |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the pharmacokinetic profiles of endogenous insulin and exogenous Insulin Aspart (IAsp) in type 2 diabetes patients treated with continuous subcutaneous (sc) IAsp infusion via insulin pump with or without intravenous (iv) glucose infusion |
At evaluere farmakokinetiske (PK) profiler af endogent insulin og eksogent tilført Insulin Aspart (IAsp) hos type 2 DM patienter behandlet med kontinuerlig sc IAsp infusion via insulin pumpe med eller uden samtidig intravenøs (iv) tilførsel af glukose. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the pharmacodynamic (PD) glucose profiles after treatment with continuous sc IAsp infusion via insulin pump with or without iv glucose infusion. |
At evaluere farmakodynamiske (PD) glukose profiler efter behandling med IAsp indgivet som kontinuerlig sc infusion via insulin pumpe med eller uden samtidig iv tilførsel af glukose.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Signed and dated informed consent
• Type 2 diabetes according to the WHO classification for at least 6 months
• Insulin-naive patients who have never been treated with insulin
• HbA1c < 9% according to the local laboratory
• Women and men ≥ 35 og ≤ 75 years old
• BMI between25 kg /m2 og 42 kg /m2, both values are included |
• Underskrevet og dateret samtykkeerklæring
• Type 2 diabetes ifl. WHO klassifikation i minimum 6 mdr.
• Insulin naive patienter, som aldrig før har været i behandling med insulin
• HbA1c < 9% ifl. hospitalslab.
• Kvinder og mænd ≥ 35 og ≤ 75 år
• BMI mellem 25 kg /m2 og 42 kg /m2, begge værdier er inkluderet
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E.4 | Principal exclusion criteria |
• Suspected or known allergy to the trial drug or similar medications
• Treatment with the drugs that after investigator judgment could potentially interfere with plasma glucose levels
• Heart: Unstable angina pectoris, AMI < 12 months old or severe heart failure according to NYHA III-IV
• BP: Severe uncontrolled hypertension with BP > 180/110 mmHg (in lying position)
• Liver: Impaired liver function with plasma ALAT or alkaline phosphatase levels > 2 times the upper normal limit according to the local laboratory
• Kidneys: eGFR< 50 ml/min/l according to the local laboratory
• Pregnancy, lactation or desire for pregnancy in the study period and for women in childbearing age without adequate contraception-adequate contraception is: sterilisation, hysterectomy or current use of contraceptive pills, coil, gestagen depot injection, subdermal implantation, hormonal vaginal ring and transdermal depot patch.
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• Mistænkt eller kendt allergi overfor forsøgsmedikamenterne eller lignende medikamenter.
• Behandling med lægemidler, som efter Investigators vurdering, kunne potentielt påvirke P-glukose niveauer
• Hjerte: Ustabil angina pectoris, AMI < 12 mdr. eller hjerteinsufficiens klassificeret til NYHA III-IV
• BT: Svær ukontrollerbar hypertension med BT > 180/110 mmHg (liggende)
• Lever: Nedsat leverfunktion svarende til plasma-ALAT eller –basisk phosphatase > 2x øvre grænseværdi for det lokale laboratorium
• Nyrer: eGFR< 50 ml/min/l, ifl. lokalt laboratorium
• Enhver sygdom, som Investigator vurderer, kan påvirke forsøget
• Graviditet, amning eller ønske om graviditet i studieperioden, samt for kvinder i den fødedygtige alder uden tilstrækkelig beskyttelse mod graviditet – tilstrækkelig er sterilisation, hysterektomi eller aktuel anvendelse af p-piller, spiral, gestagendepotinjektion, subdermal implantation, hormonal vaginalring samt transdermal depotplaster.
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E.5 End points |
E.5.1 | Primary end point(s) |
• PK profiles of patient serum endogenous insulin concentration curves under treatment regiment A (without iv glucose infusion) and B (with iv glucose infusion) |
• PK profiler af patientens serum endogent insulin koncentration kurver ved indlæggelser A (uden glukose tilførsel iv) og B (med glukose tilførsel iv) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• PK profiles of patient serum IAsp concentration curves under treatment regiment A and B
• PD profiles of inividual plasma glucose concentration curves under treatment regiment A and B |
• PK profiler af patientens serum IAsp koncentration kurver ved indlæggelser A og B
• PD profiler af individuelle plasma glukose koncentration kurver ved indlæggelser A og B
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Patienterne er deres egne kontroller |
The patients are own controls |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is the last visit of the last patient |
Afsluttning af forsøget er det sidste besøg af den sidste forsøgsperson |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |