Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
With
Eli Lilly and Company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Is at least 18 years old at study start
Has been diagnosed with type 2 diabetes mellitus
Has HbA1c of 7.1% to 11.0%, inclusive, at study start
Has been treated with diet and exercise alone or with a stable regimen of metformin, pioglitazone, or a combination of metformin and pioglitazone, for a minimum of 2 months prior to study start
Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: hormone replacement therapy (female subjects); antihypertensive agents; thyroid replacement therapy; or antidepressant agents
You may not be if
Clinically significant medical condition that could potentially affect study participation including:
Acute or chronic pancreatitis
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2
Active cardiovascular disease within 3 months of study start
Underlying hepatic or renal disease
Inflammatory bowel disease, or other severe gastrointestinal diseases (particularly those that may affect gastric emptying, such as gastroparesis, pyloric stenosis, and metabolic surgery)
Has had \> 2 episodes of major hypoglycemia in the preceding 6 months before study start
Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start
Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
* Any exposure to exenatide (BYETTA®, exenatide once weekly, or exenatide suspension), liraglutide (Victoza®), or any GLP-1 receptor agonist
* Any DPP-IV inhibitor, sulfonylurea (SU), or rosiglitazone (Avandia®) within 3 months prior to study start
* Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days prior to study start
* Insulin within 2 weeks prior to study start, or for more than 1 week within 3 months prior to study start
* Systemic corticosteroids by oral, intravenous, intra-articular, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
* Prescription or over-the-counter weight loss medications within 3 months prior to study start
Clareo Health | A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension
