A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension

Completed · Phase 2

Conditions studied: Type 2 Diabetes

In brief

The purpose of Study BCB111 is to collect efficacy, pharmacokinetic, pharmacodynamic, safety, and tolerability data in patients with type 2 diabetes to assess the feasibility of once monthly dosing of the exenatide suspension formulation.

Key facts

Study ID

NCT01104701

Run by

AstraZeneca

People needed

121

Starts

2010-05-01

Expected to finish

2010-12-01

Last updated by the study team

2015-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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