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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: exenatide once weekly; Drug: exenatide once monthly suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT01104701

BCB111

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 4 patient groups

Group A

Active Comparator group

Description:

2 mg exenatide once weekly subcutaneous (SC). This arm is used as a reference arm in the study.

Treatment:

Drug: exenatide once weekly

Group B

Experimental group

Description:

Low dose 5 mg exenatide once monthly suspension SC.

Treatment:

Drug: exenatide once monthly suspension

Drug: exenatide once monthly suspension

Drug: exenatide once monthly suspension

Group C

Experimental group

Description:

Medium dose 8 mg exenatide once monthly suspension SC.

Treatment:

Drug: exenatide once monthly suspension

Drug: exenatide once monthly suspension

Drug: exenatide once monthly suspension

Group D

Experimental group

Description:

High dose 11 mg exenatide once monthly suspension SC.

Treatment:

Drug: exenatide once monthly suspension

Drug: exenatide once monthly suspension

Drug: exenatide once monthly suspension