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
Phase 2
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: 50 mg PB1023Drug: 70 mg PB1023Other: Diet and ExerciseDrug: 100 mg PB1023Drug: MetforminDrug: Placebo (0.9% Sodium Chloride)Drug: Victoza®Drug: Metformin and SulfonylureaDrug: Sulfonylurea
- Registration Number
- NCT01658501
- Lead Sponsor
- PhaseBio Pharmaceuticals Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 593
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.
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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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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diet and Exercise 100 mg PB1023 Diet and exercise only. Metformin 50 mg PB1023 Metformin only Metformin 70 mg PB1023 Metformin only Metformin 100 mg PB1023 Metformin only Diet and Exercise 50 mg PB1023 Diet and exercise only. Diet and Exercise 70 mg PB1023 Diet and exercise only. Diet and Exercise Placebo (0.9% Sodium Chloride) Diet and exercise only. Diet and Exercise Victoza® Diet and exercise only. Metformin Placebo (0.9% Sodium Chloride) Metformin only Metformin Victoza® Metformin only Sulfonylurea 50 mg PB1023 Sulfonylurea only Sulfonylurea 70 mg PB1023 Sulfonylurea only Sulfonylurea 100 mg PB1023 Sulfonylurea only Sulfonylurea Placebo (0.9% Sodium Chloride) Sulfonylurea only Sulfonylurea Victoza® Sulfonylurea only Metformin and Sulfonylurea 50 mg PB1023 Metformin and Sulfonylurea combination therapy Metformin and Sulfonylurea 70 mg PB1023 Metformin and Sulfonylurea combination therapy Metformin and Sulfonylurea 100 mg PB1023 Metformin and Sulfonylurea combination therapy Metformin and Sulfonylurea Placebo (0.9% Sodium Chloride) Metformin and Sulfonylurea combination therapy PB1023 50 mg PB1023 PB1023 weekly SC injection Placebo Comparator Placebo (0.9% Sodium Chloride) Placebo (0.9% Sodium Chloride) weekly SC injection Placebo Comparator Diet and Exercise Placebo (0.9% Sodium Chloride) weekly SC injection PB1023 70 mg PB1023 PB1023 weekly SC injection PB1023 100 mg PB1023 PB1023 weekly SC injection PB1023 Diet and Exercise PB1023 weekly SC injection PB1023 Sulfonylurea PB1023 weekly SC injection Placebo Comparator Sulfonylurea Placebo (0.9% Sodium Chloride) weekly SC injection Placebo Comparator Metformin and Sulfonylurea Placebo (0.9% Sodium Chloride) weekly SC injection Active Comparator Victoza® Active Comparator (Victoza) daily SC injection Active Comparator Diet and Exercise Active Comparator (Victoza) daily SC injection Active Comparator Metformin Active Comparator (Victoza) daily SC injection Active Comparator Sulfonylurea Active Comparator (Victoza) daily SC injection Metformin and Sulfonylurea Victoza® Metformin and Sulfonylurea combination therapy PB1023 Metformin and Sulfonylurea PB1023 weekly SC injection Active Comparator Metformin and Sulfonylurea Active Comparator (Victoza) daily SC injection PB1023 Metformin PB1023 weekly SC injection Placebo Comparator Metformin Placebo (0.9% Sodium Chloride) weekly SC injection
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 Proportion of subjects reaching HbA1c targets (<7.0%) after 20 weeks of dosing Baseline and 20 weeks