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 |
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.
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.
We found this trial at
93
sites
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