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

AstraZeneca121 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

121

Conditions

Type 2 Diabetes

Interventions

exenatide once weeklyDRUG

subcutaneous injection, 2 mg, once a week

exenatide once monthly suspensionDRUG

subcutaneous injection, low dose, once a month

exenatide once monthly suspensionDRUG

subcutaneous injection, medium dose, once a month

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Phoenix, Arizona, United States

Research Site

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population

HbA1c was measured as a percent of total hemoglobin at screening, Baseline, and during treatment on Weeks 4, 8, 12, 16, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. The Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.

Time frame: Baseline (Day 1) to 20 weeks

Secondary Outcomes

Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population

HbA1c was measured as a percent (%) of total hemoglobin. The Target values for HbA1c were \<7% and ≤ 6.5% at Week 20. Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.

Time frame: Week 20

Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population

Body weight was measured in kilograms (kg) at Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.

Time frame: Baseline (Day 1) to Week 20

Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population

Fasting glucose was measured in milligrams per deciliter (mg/dL) at screening, Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.

Time frame: Baseline (Day 1) to Week 20

Data from ClinicalTrials.gov

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