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
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusType II diabetes mellitus.
- Registration Number
- EUCTR2008-000854-11-IT
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 822
[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
[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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method