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A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Randomized, Multi-dose, Controlled Trial Investigating the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension.

NCT01104701•AstraZeneca

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+5 more criteria

Locations (2)

Research Site

Phoenix, Arizona, United States

Research Site

Lincoln, Nebraska, United States

Key Dates

Start Date

May 1, 2010

Primary Completion Date

December 1, 2010

Completion Date

December 1, 2010

Last Updated

August 20, 2015

Enrollment

121

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

exenatide once weekly

DRUG

exenatide once monthly suspension

DRUG

exenatide once monthly suspension

DRUG

exenatide once monthly suspension

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes

Closed-loop in Adults With Type 2 Diabetes

SGLT2i, Pioglitazone, and Ketone Production in T2D