Type 2 Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
DRUG50 mg PB1023
DRUG70 mg PB1023
DRUG100 mg PB1023
DRUGVictoza®
OTHERDiet and Exercise
DRUGMetformin
DRUGSulfonylurea
DRUGMetformin and Sulfonylurea
Sponsors
PhaseBio Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of dose response of Glymera as measured as the change from baseline in HbA1c after 20 weeks of dosing with Glymera compared to placebo and active comparator | Baseline and 20 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Compare change from baseline in weekly fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator | Baseline and 20 weeks |
| Description of the incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator | Up to 23 weeks |
| Describe the frequencies of adverse events in the treatment groups | Up to 23 weeks |
| Proportion of subjects reaching HbA1c targets (<7.0%) after 20 weeks of dosing | Baseline and 20 weeks |
Countries
United States
Outcome results
None listed