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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00894322

Type 2 Diabetes Mellitus

COMPLETED PHASE1/PHASE2

A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)

NCT00877890

Type 2 Diabetes Mellitus

COMPLETED PHASE3

Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

NCT00765817

Type 2 Diabetes

COMPLETED PHASE3

A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

NCT00360334

Type 2 Diabetes

COMPLETED PHASE3

Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

NCT00085969

Diabetes Mellitus, Type 2

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

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

Group Type ACTIVE_COMPARATOR

exenatide once weekly

Intervention Type DRUG

subcutaneous injection, 2 mg, once a week

Group B

Low dose 5 mg exenatide once monthly suspension SC.

Group Type EXPERIMENTAL

exenatide once monthly suspension

Intervention Type DRUG

subcutaneous injection, low dose, once a month

Group C

Medium dose 8 mg exenatide once monthly suspension SC.

Group Type EXPERIMENTAL

exenatide once monthly suspension

Intervention Type DRUG

subcutaneous injection, medium dose, once a month

Group D

High dose 11 mg exenatide once monthly suspension SC.

Group Type EXPERIMENTAL

exenatide once monthly suspension

Intervention Type DRUG

subcutaneous injection, high dose, once a month

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

exenatide once weekly

subcutaneous injection, 2 mg, once a week

Intervention Type DRUG

exenatide once monthly suspension

subcutaneous injection, low dose, once a month

Intervention Type DRUG

exenatide once monthly suspension

subcutaneous injection, medium dose, once a month

Intervention Type DRUG

exenatide once monthly suspension

subcutaneous injection, high dose, once a month

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No