E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 Diabetes |
Diabete di Tipo 2 |
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E.1.1.1 | Medical condition in easily understood language |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049746 |
E.1.2 | Term | Insulin-requiring 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 |
The primary objective of this study is to demonstrate that LY2605541 is noninferior to insulin glargine for the change in HbA1c from baseline to 26 weeks of treatment in insulin naive patients with T2DM |
L'obiettivo primario di questo studio è di dimostrare che LY2605541 non è inferiore a insulina glargine per la variazione di HbA1c dal basale alla 26 settimanae di trattamento nei pazienti insulino-naive con diabete di tipo 2 |
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E.2.2 | Secondary objectives of the trial |
Gated: 1. Nocturnal hypoglycemia rate during the first 26 weeks of treatment 2. Proportion of patients with HbA1c <7.0% at 26 weeks and no nocturnal hypoglycemia during the first 26 weeks of treatment 3. HbA1c change from baseline after 26 weeks of treatment 4. Proportion of patients with HbA1c <7.0% after 26 weeks of treatment 5. Total hypoglycemia rate during the first 26 weeks of treatment 6. Fasting serum glucose (FSG) by laboratory measurement after 26 weeks of treatment |
1. Tasso di ipoglicemia notturna durante le prime 26 settimane di trattamento 2. Proporzione di pazienti con HbA1c <7,0% a 26 settimane e non ipoglicemia notturna durante le prime 26 settimane di trattamento 3. Cambimenti di HbA1c dal basale dopo 26 settimane di trattamento 4. Proporzione di pazienti con HbA1c <7,0% dopo 26 settimane di trattamento 5. Tasso totale di ipoglicemie durante le prime 26 settimane di trattamento 6. Glicemia a digiuno (FSG) mediante misurazione di laboratorio dopo 26 settimane di trattamento |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
PHARMACOGENETIC:
Vers:a
Date:2010/09/02
Title:Pharmacogenetic Evaluations (26 June 2011)
Objectives:Where local regulations allow, a blood sample will be collected for pharmacogenetic analysis. It is a onetime collection, as noted in the Study Schedule. Samples will be stored and analysis may be performed on genetic variants thought to play a role in glucose and insulin regulation, beta cell function, characterization of patients' responsiveness to LY2605541, or diabetes- related metabolic abnormalities.
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FARMACOGENETICA:
Vers:a
Data:2010/09/02
Titolo:Valutazioni Farmacogenetiche
Obiettivi:Dove le normative locali lo consentono, un campione di sangue sarà raccolto per l' analisi farmacogenetica. E un prelievo unico come indicato nella Studio Pianificazione. I campioni saranno conservati e analizzati su varianti genetiche che si ritengono svolgere un ruolo sul metabolismo di glucosio e insulina, sulla funzione delle cellule beta, sulla caratterizzazione dei pazienti e la risposta risposta ai LY2605541, sulle anomalie metaboliche correlate al diabete
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E.3 | Principal inclusion criteria |
T2DM (per World Health Organization [WHO] Classification of Diabetes not treated with insulin [2] Age 18 years of age or older [3] Duration of diabetes ≥ 1 year |
1. Diabete di tipo 2 (per Organizzazione mondiale della sanità [Oms] 2. Età 18 anni di età o più anziani 3. Durata del diabete ≥ 1 anno |
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E.4 | Principal exclusion criteria |
Insulin therapy: have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short term treatment of acute conditions, and up to a maximum of 4 continuous weeks. [13] Concomitant medications: Rosiglitazone, glucagon-like peptide-1 (GLP-1) receptor agonist (for example, exenatide, exenatide onceweekly or liraglutide) used concurrently or within 3 months prior to screening. [14] Local OAM restrictions: for patients on OAMs, restrictions for cardiac, renal and hepatic diseases, local product regulations must apply [15] Prescription weight loss medications: are currently taking, or have taken within the 3 months preceding screening, prescription or over-thecounter medications to promote weight loss. [16] Severe hypoglycemia history |
La terapia insulinica: hanno usato la terapia insulinica (al di fuori della gravidanza) in qualsiasi momento negli ultimi 2 anni, tranne che per trattamento a breve termine di acuta condizioni, e fino ad un massimo di 4 settimane ininterrotte. [13] I trattamenti concomitanti: Rosiglitazone, glucagone-like peptide-1 (GLP-1) agonista del recettore (ad esempio, exenatide, onceweekly exenatide o liraglutide) utilizzati contemporaneamente o entro 3 mesi prima screening. [14] Restrizioni locali OAM: per i pazienti in OAMs, restrizioni per malattie cardiache, renali ed epatiche, i regolamenti di prodotti locali devono applicare [15] Prescrizione farmaci perdita di peso: sono attualmente in corso, o hanno presa entro i 3 mesi precedenti lo screening, prescrizione o over-thecounter farmaci per promuovere la perdita di peso. [16] Storia ipoglicemia grave |
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E.5 End points |
E.5.1 | Primary end point(s) |
A change of HbA1c from baseline to 26 weeks that is not inferior to glargine. |
Cambio di HbA1c dal basale a 26 settimane non è inferiore a glargine. |
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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) |
Nocturnal and total hypoglycemia rates and incidences superior to glargine, proportion of patients with HbA1c <7% at 26 weeks of treatment (also HbA1c <7% with no nocturnal hypoglycemia, FPG by laboratory, FBG by SMBG, weight change from baseline, SMBG 6-pt profile, HbA1c, insulin dose, number of dose adjustments to steady state, triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, insulin and insulin analog antibodies, other safety endpoints such as serious adverse events, vitals, treatment-emergent adverse events, Health Outcomes measurements EQ-5D, ITSQ, and LBSS. |
I tassi di ipoglicemia notturna e totale e l'incidenza superiore al glargine, la proporzione di pazienti con HbA1c <7% a 26 settimane di trattamento (anche HbA1c <7% senza l'ipoglicemia notturna, glicemia a digiuno da laboratorio, FBG da SMBG, cambiamenti di peso dal basale, SMBG 6 pt profilo, HbA1c, dose di insulina, il numero di aggiustamenti della dose di costante Stato, trigliceridi, colesterolo totale, colesterolo LDL, colesterolo HDL, anticorpi analogo dell'insulina e l'insulina, gli endpoint di sicurezza quali gli eventi avversi gravi, vitali, gli eventi avversi trattamento-emergenti, Risultati Salute misure EQ-5D, ITSQ e LBSS. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
All gates objective endpoints are at 26 weeks of treatment for many of the non-gated secondary endpoints have various timepoints such as 0 to 12 weeks, 0 to 26 weeks, 0 to 52 weeks, 0 to 78 weeks, 12 to 26 weeks, 26 to 52 weeks, 52 to 78 weeks for nocturnal and total hypoglycemia incidences; 0 to 12 weeks, 0 to 52 weeks, 0 to 78 weeks, 12 to 26 weeks, 26 to 52 weeks, 52 to 78 weeks for nocturnal and total hypoglycemia rates; 52 and 78 weeks for FPG by laboratory, 52 and 78 weeks for proportion of patients with HbA1c <7%, and the same as immediately above with no nocturnal hypoglycemia, and HbA1c change from baseline |
Tutti gli endpoint secondari ''GATED'' sono a 26 settimane di trattamento Per molti degli endpoint secondari non-dipendenti si hanno riferimenti temporali diversi, come da 0 a 12 settimane, da 0 a 26 settimane, da 0 a 52 settimane, da 0 a 78 settimane, da 12 a 26 settimane, 26-52 settimane, 52-78 settimane per l'ipoglicemia notturna e totale incidenza, 0 a 12 settimane, da 0 a 52 settimane, da 0 a 78 settimane, da 12 a 26 settimane, 26-52 settimane, 52-78 settimane per l'ipoglicemia notturna e totale tassi, 52 e 78 settimane per FPG da laboratorio, 52 e 78 settimane per la proporzione di pazienti con HbA1c <7%, e la stessa senza l'ipoglicemia notturna, e il cambiamento HbA1c dal basale |
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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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Insulina Glargine |
Insulin Glargin |
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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
| 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 76 |
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 |
Argentina |
Australia |
Brazil |
Canada |
Israel |
Mexico |
New Zealand |
Russian Federation |
South Africa |
Turkey |
United States |
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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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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 | 28 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 28 |
E.8.9.2 | In all countries concerned by the trial days | 0 |