Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the PD Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Weekly SC Dosing in Adults With T2DM



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:July 2012
End Date:July 2013

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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.


Inclusion Criteria:

- Male and female subjects 18 to 75 years of age, inclusive;

- Body mass index ≤45 kg/m2;

- Diagnosed with T2DM with HbA1c of ≥7.0% and ≤11.0% and treated with diet and exercise
alone, or with stable doses of metformin alone, sulfonylurea alone or metformin and
sulfonylurea.

Exclusion Criteria:

- Currently taking or have taken within the last 6 months non-oral antihyperglycemic
agents (eg, insulin, Byetta®, Bydureon®, or Victoza). Short-term use of insulin
within this period will not be cause for exclusion if insulin was used during the
treatment of an acute intercurrent illness;

- Known allergy to or serious adverse effect caused by an approved or investigational
glucagon-like peptide-1 (GLP-1) receptor analog/agonist;

- Unstable cardiovascular disease;

- History of weight loss surgery or other gastrointestinal surgical procedures that
could possibly interfere with the mechanism of action of GLP-1 receptor agonists;

- Based on contraindications/warnings identified with other GLP-1 receptor agonists,
subjects will be excluded if they have: History, symptoms, or signs of pancreatitis
or severe gastrointestinal disease (ie, gastroparesis) or Personal or family history
of medullary thyroid tumors or history of Multiple Endocrine Neoplasia Syndrome Type
2;

- Clinically significant renal and/or hepatic dysfunction;

- Pregnant or lactating female subjects.
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