Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least 18 years old
Diagnosed with type 2 diabetes mellitus
HbA1c of 7.1% to 11.0%, inclusive, at screening
Has stable body weight, i.e., not varying by \>3% for at least 3 months prior to screening
Fasting plasma glucose concentration \<280 mg/dL (15.5 mmol/L) at screening
Body mass index of \<45 kg/m2 at screening
Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to Visit 1 (Screening)
You may not be if
History of pancreatitis or triglycerides \>=500 mg/dL
Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
History of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance \<50 mL/min
Active cardiovascular disease
Presence or history of severe congestive heart failure
Central nervous system disease, including epilepsy
Liver disease
History of severe gastrointestinal diseases
Clinically significant malignant disease
Repeated severe hypoglycemia within the last 6 months
Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog
Any DPP-4 inhibitor within 3 months prior screening
Clareo Health | Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus
