| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Type II diabetes mellitus. |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10045242 |
| E.1.2 | Term | Type II diabetes mellitus |
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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 is to test the hypothesis that exenatide once weekly is superior to metformin, sitagliptin, and pioglitazone in HbA1c reduction at 26 weeks compared to baseline, in drug-naive patients with type 2 diabetes who are inadequately treated with diet and exercise. |
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| E.2.2 | Secondary objectives of the trial |
| The secondary objectives of the study are to compare exenatide once weekly to metformin, sitagliptin, and pioglitazone over 26 weeks with respect to: -the proportion of patients achieving HbA1c <=7% and <=6.5% -change in fasting serum glucose -change in body weight -7-point self-monitored blood glucose (SMBG) profile (blood glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime) -change in serum lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL-C], fasting triglycerides, calculated low-density lipoprotein cholesterol [LDL-C]) -incidence of hypoglycemic events -change in systolic and diastolic blood pressure -safety and tolerability -health outcomes. |
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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 |
FARMACOGENETICA: Versione:(1) Data:2008/04/04 Titolo:Sample Banking Addendum H8O-MC-GWCH(1). Obiettivi:Eli Lilly & Company ha stabilito un programma denominato Combined Specimen Banking (CSB), per la conservazione dei campioni dei pazienti arruolati negli studi sponsorizzati dalla societa', con un processo di anonimizzazione dei campioni. La partecipazione dei pazienti e' volontaria. La scelta di non partecipare all'addendum non sara' considerata una violazione di protocollo. I campioni saranno raccolti e conservati al fine di identificare i geni e/o il prodotto del gene e/o marker biochimici associati alla patologia e/o la risposta al farmaco in studio o altri farmaci assunti duranti lo studio. Per esempio, i campioni raccolti dai pazienti potranno essere usati per ricerche mirate ad identificare differenze nel siero o nel plasma (proteine) o nel DNA (polimorfismi) associate con un aumento di rischio per patologie quali il diabete di tipo 2. Inoltre, potranno essere ricercati biomarkers genetici o proteici correlati alla risposta terapeutica a exenatide o ad altri farmaci che il paziente ha assunto durante lo studio. Un possibile esempio, puo' essere la ricerca di varianti di DNA nel recettore GLP-1 e la risposta a farmaci quali exenatide.
ALTRI SOTTOSTUDI: Sample Storage Addendum H8O-MC-GWCH(2.1) 07/05/08.Obiet primario e' raccogliere e conservare campioni di sangue per ricercare biomarkers associati al diabete mellito II e al trattamento con exenatide.
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| E.3 | Principal inclusion criteria |
| [1]Present with type 2 diabetes based on the disease diagnostic criteria as described by the World Health Organization (WHO) (refer to Section 4.1.1) and are treated with diet and exercise alone. [2]Are at least 18 years of age at screening. [3]Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0%, inclusive. [4]Have a body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive. [5]Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening). [6]This inclusion criterion applies to females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only. -Are not breastfeeding. -Test negative for pregnancy at the time of screening based on a blood serum pregnancy test. -Intend not to become pregnant during the study. -Have practiced a reliable method of birth control (e.g., use of oral contraceptives or approved hormonal implant; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for at least 6 weeks prior to screening. -Agree to continue to use a reliable method of birth control (see above) during the study, as determined by the investigator. |
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| E.4 | Principal exclusion criteria |
| [7]Are Lilly, Amylin, or Alkermes employees. [8]Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [9]Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure (New York Heart Association Class III or IV [CCNYHA 1994]), coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study. See Protocol Attachment GWCH.4 for descriptions of the cardiac disease classifications. Refer to Exclusion Criterion [11] regarding local label exclusions for cardiac failure. [10]Have any contraindication for the study drug (exenatide, metformin, sitagliptin, or pioglitazone, or the excipients contained in these agents) to which they may be assigned. [11]Have had poorly controlled blood pressure (>=160 mm Hg, systolic value; >=110 mm Hg, diastolic value) within the last 4 weeks. [12]Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, alanine aminotransferase (ALT), or serum glutamic pyruvic transaminase (SGPT) greater than 2.5 times the upper limit of the reference range. [13]Have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine >=1.5 mg/dL (132 mmol/L) for males and >=1.2 mg/dL (110 mmol/L) for females. [14]Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years. [15]Have known hemoglobinopathy or chronic anemia (hemoglobin concentration <115 g/L for males, <105 g/L for females). [16]Have had more than 2 episodes of major hypoglycemia within 6 months prior to screening. Refer to Section 5.5.5 for more information on hypoglycemia. [17]Patients with a history of severe GI disorder (e.g., gastroparesis) [18]Patients with a history of acute or chronic pancreatitis. [19]Are known to have active proliferative retinopathy. [20]Have been treated within 8 weeks of screening with systemic glucocorticoid therapy by oral, intravenous, or intramuscular route, or are regularly treated with potent, inhaled or intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving chronic glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g., Addison disease). [21]Have been treated with drugs that promote weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acomplia [rimonabant], Acutrim [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening. [22]Have been treated with any antidiabetic agent within 3 months prior to screening. [23]Have had an organ transplant. [24]Have any exclusion criteria required by local law. [25]Have previously completed or discontinued study drug in this study, withdrawn from this study or any other study investigating exenatide once weekly. [26]Have received treatment within the last 30 days (or longer, if local guidelines require) with a drug that has not received regulatory approval for any indication at the time of study entry. [27]Are currently enrolled in any other clinical study. [28]Have any other condition (including known drug or alcohol abuse or psychiatric disorder) that renders them unable to understand the nature, scope, and possible consequences of the study or precludes them from following and completing the protocol, in the opinion of the investigator. [29]Fail to satisfy the investigator of suitability to participate for any other reason. |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| L’efficacia primaria sara' valutata misurando i cambiamenti di HbA1c dal baseline alla 26 settimana. |
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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 | 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 | No |
| 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 | 4 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 39 |
| 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
|
| Si tratta dell’ultima visita del soggetto inserito nella sperimentazione. |
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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 | 2 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
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