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Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the Pharmacodynamic Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Once-Weekly Subcutaneous Dosing in Adult Subjects With Inadequately Treated Type 2 Diabetes Mellitus
Primary objective: The primary objective of this study is to define the dose response of Glymera as measured as the change from baseline in hemoglobin A1c (HbA1c) following 20 weeks of once-weekly dosing. Secondary objectives: The secondary objectives are to: * Describe incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator; * Compare change from baseline in HbA1c following 20 weeks of dosing compared to placebo and active comparator; * Compare change from baseline in fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator; * Describe the frequencies of adverse events in the treatment groups; and * Describe the above endpoints for the following subgroups of subjects according to baseline type 2 diabetes mellitus (T2DM) therapy: diet and exercise only, metformin only, sulfonylurea only, or metformin and sulfonylurea combination therapy.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Anniston, Alabama, United States
Birmingham, Alabama, United States
Gulf Shores, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Muscle Shoals, Alabama, United States
Chandler, Arizona, United States
Glendale, Arizona, United States
Goodyear, Arizona, United States
Tucson, Arizona, United States
Start Date
July 1, 2012
Primary Completion Date
July 1, 2013
Completion Date
July 1, 2013
Last Updated
December 7, 2015
593
ACTUAL participants
50 mg PB1023
DRUG
70 mg PB1023
DRUG
100 mg PB1023
DRUG
Placebo (0.9% Sodium Chloride)
DRUG
Victoza®
DRUG
Diet and Exercise
OTHER
Metformin
DRUG
Sulfonylurea
DRUG
Metformin and Sulfonylurea
DRUG
Lead Sponsor
PhaseBio Pharmaceuticals Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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.
View ClinicalTrials.gov Terms and ConditionsNCT07433062