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

2014-08-27 03:14:33 | BioPortfolio

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Type 2 Diabetes

Intervention

exenatide once weekly, exenatide once monthly suspension, exenatide once monthly suspension, exenatide once monthly suspension

Location

Research Site
Phoenix
Arizona
United States

Status

Completed

Source

Bristol-Myers Squibb

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:33-0400

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

This study is designed to evaluate the pharmacokinetics, tolerability, and safety of exenatide once weekly suspension in both healthy subjects and in subjects with type 2 diabetes. The st...

A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects

Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in ...

Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type...

Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes Taking Twice-Daily Exenatide or Once-Weekly Exenatide

The purpose of this substudy is to obtain CGM data from individuals taking exenatide. The CGM measurements gathered before starting and during treatment with exenatide IR and/or exenatide ...

An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes

The primary purpose of this study is to assess the anti-exenatide-antibody response to exenatide re-exposure as measured by anti-exenatide antibodies and incidence of treatment-emergent al...

PubMed Articles [1610 Associated PubMed Articles listed on BioPortfolio]

Effects of exenatide once weekly plus dapagliflozin, exenatide once weekly, or dapagliflozin added to metformin monotherapy in subgroups of patients with type 2 diabetes in the DURATION-8 randomized controlled trial.

This analysis assessed whether responses with exenatide once weekly (QW) plus dapagliflozin (n=231), exenatide QW (n=230), or dapagliflozin (n=233) differed in key patient subpopulations of the DURATI...

Treatment of clozapine-associated obesity and diabetes with exenatide (CODEX) in adults with schizophrenia: a randomised controlled trial.

Clozapine causes obesity and type-2 diabetes (T2DM). Glucagon-like-peptide-1 (GLP-1) agonists (e.g. exenatide) can counter clozapine-associated GLP-1 dysregulation in animals, and may be beneficial in...

A Randomized Controlled Trial of Dapagliflozin Plus Once-Weekly Exenatide Versus Placebo in Individuals with Obesity and Without Diabetes: Metabolic Effects and Markers Associated with Bodyweight Loss.

The sodium-glucose cotransporter 2 inhibitor dapagliflozin and the glucagon-like peptide-1 (GLP-1) receptor agonist exenatide reduce bodyweight via differing and complementary mechanisms. This post ho...

The Effects of Exenatide and Metformin on Endothelial Function in Newly Diagnosed Type 2 Diabetes Mellitus Patients: A Case-Control Study.

Exenatide is a new antidiabetic glucagon-like peptide-1 receptor agonist. In addition to its hypoglycemic effect, exenatide may have a potential protective benefit on vascular endothelial function. Th...

Effects of exenatide once weekly plus dapagliflozin, exenatide once weekly, or dapagliflozin added to metformin monotherapy on body weight, systolic blood pressure, and triglycerides in patients with type 2 diabetes in the DURATION-8 study.

This post hoc analysis assessed the effects on cardiovascular risk factors of body weight, systolic blood pressure (SBP), and triglycerides after 28 weeks' treatment with exenatide once weekly (QW) pl...

Medical and Biotech [MESH] Definitions

A single citation covering several articles of various degrees of specificity or a single citation covering papers or abstracts presented at a meeting. A subject overall refers to a series of articles on a single subject; a congress overall refers to papers presented at a formal local, regional, national, or international gathering; a society overall refers to papers presented at an annual, semi-annual, monthly, weekly, or other meeting of a society, academy, institute, hospital, etc. The publication type may be used for a single citation with or without the additional indexing or cataloging of individual papers. The individual papers, however, are not labeled OVERALL.

Publications printed and distributed daily, weekly, or at some other regular and usually short interval, containing news, articles of opinion (as editorials and letters), features, advertising, and announcements of current interest. (Webster's 3d ed)

Publications printed and distributed daily, weekly, or at some other regular and usually short interval, containing news, articles of opinion (as editorials and letters), features, advertising, and announcements of current interest. (Webster's 3d ed)

The tendency of a phenomenon to recur at regular intervals; in biological systems, the recurrence of certain activities (including hormonal, cellular, neural) may be annual, seasonal, monthly, daily, or more frequently (ultradian).

A readily reversible suspension of sensorimotor interaction with the environment, usually associated with recumbency and immobility.

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