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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2008-000854-11-IT |
Date of registration:
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03/10/2008 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Safety and Efficacy of Exenatide Once Weekly Injection versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients with Type 2 Diabetes. - ND
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Scientific title:
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Safety and Efficacy of Exenatide Once Weekly Injection versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients with Type 2 Diabetes. - ND |
Date of first enrolment:
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01/10/2008 |
Target sample size:
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822 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000854-11 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Belgium
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France
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Germany
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Hungary
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Italy
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Poland
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Slovakia
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Spain
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United Kingdom
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Key inclusion & exclusion criteria
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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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
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 regulat
Age minimum:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Type II diabetes mellitus. MedDRA version: 9.1
Level: LLT
Classification code 10045242
Term: Type II diabetes mellitus
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Intervention(s)
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Product Name: Exenatide Product Code: LY2148568, AC2993 Pharmaceutical Form: Powder and solvent for suspension for injection CAS Number: 141732-76-5 Current Sponsor code: LY2148568, AC2993 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Powder and solvent for suspension for injection Route of administration of the placebo: Subcutaneous use
Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pioglitazone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pioglitazone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 45- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
Pharmaceutical Form: Film-coated tablet INN or Proposed INN: SITAGLIPTIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Pharmaceutical Form: Tablet INN or Proposed INN: Metformin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: 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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Secondary Objective: 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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Primary end point(s): L?efficacia primaria sara' valutata misurando i cambiamenti di HbA1c dal baseline alla 26 settimana.
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Secondary ID(s)
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H8O-MC-GWCH
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2008-000854-11-HU
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Source(s) of Monetary Support
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Results
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Results available:
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