Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 18 to 75 years, inclusive
Diagnosis of type 2 diabetes mellitus
HbA1c levels 7.5% to 11.0%, inclusive, at screening
Fasting C-peptide levels ≥ 0.2 nmol/L at screening
BMI ≥ 25 to \< 45 kg/m2 at screening
Treated with metformin monotherapy for at least 3 months prior to randomization; the metformin dose must be ≥ 850 mg daily for at least 2 months immediately prior to randomization
If a subject is being treated for hyperlipidemia or hypertension they should be on stable medication for 30 days before randomization
Subject has provided informed consent.
You may not be if
History of type 1 diabetes
History of significant weight gain or loss (\> 10%) during the 4 weeks before randomization
Use of any weight loss medication (over the counter or prescription) within 60 days of randomization
Use of any oral or injectable anti-hyperglycemic medication (other than metformin) within 3 months prior to randomization
Use of chronic and/or continuous insulin administration for \> 15 days in an outpatient setting to achieve and maintain glycemic control prior to randomization
Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or currently diagnosed as having hypoglycemia unawareness
Evidence of active infections that can interfere with the study
Presence of clinically significant organ system disease that is not stabilized or may interfere with the study
Currently receiving immunosuppressive therapy
History of positive HIV, chronic hepatitis B or C, or cirrhosis
Have symptomatic congestive heart failure or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure or stroke in the past 6 months prior to screening.
History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption
Any finding on the screening ECG that in the opinion of the investigator requires further cardiovascular evaluation
Poorly controlled hypertension defined as diastolic pressure \> 100 mm Hg or systolic pressure \> 160 mm Hg (assessed on two separate occasions during the screening period)
Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred \> 5 years ago, subject is eligible with documentation of disease-free state since treatment)
Use of known inhibitors or inducers of CYP3A4 are not permitted 30 days prior to randomization
Clareo Health | AMG 151 Amgen Protocol Number 20100761
