A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension
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
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
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01104701
- ClinicalTrials.gov processed this data on October 06, 2013
Published on BioPortfolio: 2014-08-27T03:14:33-0400
Clinical Trials
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...
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...
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 ...
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
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...
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...
Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.
Background The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. Methods We randomly assigned patients with type 2 diabe...
To evaluate treatment satisfaction in patients with type 2 diabetes (T2D), not adequately controlled by metformin, randomized to ITCA 650 (continuous exenatide in osmotic mini-pump) versus twice-daily...
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...
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