E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 Diabetes
Diabetes mellitus tipo 2 |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10012602 |
E.1.2 | Term | Diabetes mellitus (incl subtipos) |
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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 investigate if treat-to-target treatment with insulin detemir once-daily (OD) combined with metformin accompanied with dietary intervention is superior to treat-to-target treatment with insulin detemir OD combined with metformin without dietary intervention with respect to weight change after 26 weeks of treatment in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without other OADs. Investigar si el tratamiento de ajuste de dosis con insulina detemir una vez al día (OD) combinada con metformina e intervención dietética es superior al tratamiento de ajuste de dosis con insulina detemir OD combinada con metformina sin intervención con respecto al cambio en el peso corporal después de 26 semanas de tratamiento en pacientes con diabetes tipo 2 diabetes mal controlada en tratamiento con metformina con o sin otros ADO. |
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E.2.2 | Secondary objectives of the trial |
? To investigate the association between weight change at 26 weeks and baseline BMI ? To assess and compare efficacy after 26 weeks of treatment ? To assess and compare safety and tolerability after 26 weeks of treatment Investigar la asociación entre el cambio en el peso corporal a la 26 semanas y el IMC basal Evaluar y comparar la eficacia del tratamiento después de 26 semanas Evaluar y comparar la seguridad y tolerabilidad del tratamiento después de 26 semanas |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Type 2 diabetes (diagnosed clinically) for ? 6 months prior to screening ? Insulin naive subjects ? Current treatment: metformin monotherapy or metformin in any combination with the following OADs: insulin secretagogue (SU or glinide), DPP-4 inhibitor, ?-glucosidase-inhibitors (acarbose), all with an unchanged total daily dosing for at least 3 months prior to screening ? HbA1c 7.0-9.0 % (both inclusive) at screening by central laboratory analysis ? BMI 25.0-45.0 kg/m2 (both inclusive) measured at screening Diabetes tipo 2 (clínicamente diagnosticada) durante ≥ 6 meses antes de la visita de selección No tratados anteriormente con insulina Tratamiento actual: metformina en monoterapia o metformina en combinación cualquier de los siguientes ADO: secretagogos de insulina (SU o glinida), inhibidor de DPP-4 e inhibidores de la α-glucosidasa (acarbosa), todos a una dosis total diaria sin cambios durante al menos 3 meses antes de la visita de selección HbA1c 7,0 9,0 % (ambos inclusive) en visita de selección, basandose en los resultados de laboratorio central IMC 25,0 45,0 Kg/m2 (ambos) calculado en la visita de selección |
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E.4 | Principal exclusion criteria |
? Use of: TZDs or Glucagon-like peptide-1 analogue (GLP-1) receptor agonists within the last 3 months prior to Visit 1 ? Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, monoamine oxidase (MAO inhibitors) ? Anticipated initiation or change in concomitant medication known to affect weight, such as weight loss/modifying medication (e.g. sibutramine, orlistat, thyroid hormones), steroids (e.g. corticosteroids, progesterone, testosterone) and diuretics ? Any conditions that the investigator judges would interfere with trial participation or evaluation of the results ? Known or suspected allergy to insulin detemir or related products Tratamiento con una TZD o un agonista del receptor del análogo del péptido-1 similar al glucagón (GLP-1) en los 3 meses anteriores a la Visita 1 Cambio previsto en un medicamento concomitante que interfiere de forma significativa en el metabolismo de la glucosa, tales como los corticoesteroides sistémicos, los β-bloqueantes y los inhibidores de la monoaminooxidasa (IMAO) Inicio de o cambio previsto en un medicamento concomitante que afecta al peso corporal, tales como los medicamentos para perder peso (p. ej., sibutramina, orlistat, hormonas tiroideas), esteroides (p. ej., corticoesteroides, progesterona, testosterona) y los diuréticos Cualquier enfermedad o trastorno médico que, a juicio del investigador, pudiera interferir en la participación del paciente en el ensayo clínico o en la evaluación de los resultados del mismo Alergia conocida o sospecha de alergia a la insulina detemir o productos relacionados |
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E.5 End points |
E.5.1 | Primary end point(s) |
Weight change from baseline to end of the treatment period Cambio en el peso corporal con respecto al valor basal al final del periodo de tratamiento |
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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 | 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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 |
With or without dietary consultation (con o sin interveción de dieta) |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 23 |
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 | Information not present in EudraCT |
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 |
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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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Se define como la última visita del ultimo paciente. |
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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 | 2 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 2 |