E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
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 compare the efficacy of adding liraglutide versus adding IAsp to the largest meal on top of IDeg OD + metmorfin in controlling glycaemia. |
Comparar la eficacia de la insulina degludec 1v/d e insulina aspart, en la comida principal, frente a insulina degludec 1v/d y Liraglutida ambas en combinación con metformina para controlar la glucemia. |
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E.2.2 | Secondary objectives of the trial |
To compare the safety of adding liraglutide versus adding IAsp to the largest meal on top of IDeg OD + metmorfin. |
Comparar la seguridad de la insulina degludec 1v/d e insulina aspart, en la comida principal, frente a insulina degludec 1v/d y Liraglutida ambas en combinación con metformina. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- The subject must have completed the end of treatment visit of NN1250-3643 with IDeg OD + metformin. - Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol |
- El paciente deberá haber completado la visita de final del tratamiento del estudio NN1250-3643 con IDeg 1 v/d + metformina. - Capacidad y disposición a cumplir el protocolo, incluida la medición de la glucemia por el paciente, según el protocolo. |
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E.4 | Principal exclusion criteria |
- Participated in NN1250-3643 and treated with IGlar + metformin +/- DPP-IV inhibitor or IDeg + metformin + DPP-IV inhibitor - Previous treatment with glucacon like peptide 1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide) - Impaired liver function, defined as alanine aminotransferase (ALAT) ? 2.5 times the upper limit of normal at end of treatment in NN1250-3643 - Impaired renal function defined as serum-creatinine ? 125 ?mol/L (? 1.4 mg/dL) for males and ? 110 ?mol/L (? 1.3 mg/dL) for females, at end of treatment in NN1250-3643 |
- Haber participado en el estudio NN1250-3643 y recibir tratamiento con IGlar + metformina ± inhibidor de la DPP-IV o IDeg + metformina + inhibidor de la DPP-IV. - Tratamiento previo con glucagón como agonistas del receptor del GLP-1 (por ejemplo, exenatida o liraglutida). - Disfunción hepática, definida como una alanina aminotransferasa (ALAT) ? 2,5 veces el límite superior de la normalidad al final del estudio NN1250-3643. - Disfunción renal, definida como una creatinina sérica ? 125 µmol/l (? 1,4 mg/dl) en los varones y ? 110 µmol/l (? 1,3 mg/dl) en las mujeres, al final del tratamiento en el estudio NN1250-3643. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in HbA1c (%) after 26 weeks of treatment (analysed by central laboratory). |
Variación de la HbA1c (%) con respecto al período basal tras 26 semanas de tratamiento (analizada por el laboratorio central). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after 26 weeks of treatment |
Después de 26 semanas de tratamiento. |
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E.5.2 | Secondary end point(s) |
1- Change from baseline in fasting plasma glucose (FPG) after 26 weeks 2- Change from baseline in body weight after 26 weeks 3- Number of severe and minor treatment emergent hypoglycaemic episodes that have onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product |
1- Variación con respecto al valor basal de la glucosa plasmática en ayunas (GPA) después de 26 semanas. 2- Variación con respecto al valor basal del peso corporal después de 26 semanas. 3- Número de episodios de hipoglucemia intensos y leves surgidos desde el primer día de exposición al producto en investigación hasta 7 días después de la última exposición. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 - after 26 weeks 2 - after 26 weeks 3 - one week after end of treatment in this trial, week 29 at the latest |
1- Después de 26 semanas. 2- Después de 26 semanas. 3- Una semana después de finalizar el tratamiento en este ensayo, como máximo la semana 29. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
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 |
Dos grupos diferentes con insulina degludec y otro grupo de tratamiento no aleatorizado. |
Two different add-ons to insulin degludec, and one non-randomised treatment group |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Belgium |
Canada |
Czech Republic |
Denmark |
Finland |
France |
Germany |
Norway |
Serbia |
Spain |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 20 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 20 |