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 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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Metformin; Other: Diet and Exercise; Drug: Sulfonylurea; Drug: 50 mg PB1023; Drug: 70 mg PB1023; Drug: 100 mg PB1023; Drug: Placebo (0.9% Sodium Chloride); Drug: Victoza®; Drug: Metformin and Sulfonylurea

• Study Type: Interventional
• Enrollment (Actual): 593
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • 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
  • Arizona
    • Chandler, Arizona, United States
    • Glendale, Arizona, United States
    • Goodyear, Arizona, United States
    • Tucson, Arizona, United States
  • Arkansas
    • Harrisburg, Arkansas, United States
    • Little Rock, Arkansas, United States
    • Searcy, Arkansas, United States
  • California
    • Chula Vista, California, United States
    • Concord, California, United States
    • Escondido, California, United States
    • Hawaiian Gardens, California, United States
    • La Mesa, California, United States
    • Los Angeles, California, United States
    • Oceanside, California, United States
    • San Jose, California, United States
    • Santa Rosa, California, United States
    • Walnut Creek, California, United States
  • Colorado
    • Colorado Springs, Colorado, United States
    • Denver, Colorado, United States
  • Connecticut
    • Stamford, Connecticut, United States
  • Florida
    • Brandenton, Florida, United States
    • Brooksville, Florida, United States
    • Ft. Lauderdale, Florida, United States
    • Hialeah, Florida, United States
    • Jacksonville, Florida, United States
    • Miami, Florida, United States
    • New Port Richey, Florida, United States
    • Oviedo, Florida, United States
    • St. Petersburg, Florida, United States
    • Tampa, Florida, United States
  • Georgia
    • Decatur, Georgia, United States
    • Marietta, Georgia, United States
    • Roswell, Georgia, United States
    • Savannah, Georgia, United States
  • Idaho
    • Boise, Idaho, United States
  • Illinois
    • Arlington Heights, Illinois, United States
    • Chicago, Illinois, United States
  • Indiana
    • Evansville, Indiana, United States
    • Indianapolis, Indiana, United States
  • Iowa
    • Council Bluffs, Iowa, United States
  • Kansas
    • Augusta, Kansas, United States
    • Newton, Kansas, United States
    • Overland Park, Kansas, United States
    • Wichita, Kansas, United States
  • Louisiana
    • New Orleans, Louisiana, United States
  • Maryland
    • Oxon Hill, Maryland, United States
  • Michigan
    • Ypsilanti, Michigan, United States
  • Minnesota
    • Saint Paul, Minnesota, United States
  • Missouri
    • St. Louis, Missouri, United States
  • Nebraska
    • Fremont, Nebraska, United States
    • Omaha, Nebraska, United States
  • Nevada
    • Las Vegas, Nevada, United States
  • New Jersey
    • Berlin, New Jersey, United States
  • New York
    • New Windsor, New York, United States
    • Rochester, New York, United States
  • North Carolina
    • Charlotte, North Carolina, United States
    • Durham, North Carolina, United States
    • Hickory, North Carolina, United States
    • Morehead City, North Carolina, United States
    • Raleigh, North Carolina, United States
    • Wilmington, North Carolina, United States
    • Winston-Salem, North Carolina, United States
  • Ohio
    • Cincinnati, Ohio, United States
    • Cleveland, Ohio, United States
    • Delaware, Ohio, United States
    • Kettering, Ohio, United States
    • Lyndhurst, Ohio, United States
    • Wadsworth, Ohio, United States
    • Willoughby Hills, Ohio, United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
    • Tulsa, Oklahoma, United States
  • Oregon
    • Eugene, Oregon, United States
  • South Carolina
    • Greer, South Carolina, United States
    • Spartanburg, South Carolina, United States
  • Texas
    • Austin, Texas, United States
    • Corpus Christi, Texas, United States
    • Dallas, Texas, United States
    • Houston, Texas, United States
    • Hurst, Texas, United States
    • Katy, Texas, United States
  • Utah
    • Magna, Utah, United States
    • West Jordan, Utah, United States
  • Virginia
    • Burke, Virginia, United States
    • Richmond, Virginia, United States
    • Virginia Beach, Virginia, United States
  • Washington
    • Renton, Washington, United States
  • Wisconsin
    • Kenosha, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet and Exercise; Diet and exercise only.	Drug: 50 mg PB1023; Drug: 70 mg PB1023; Drug: 100 mg PB1023; Drug: Placebo (0.9% Sodium Chloride); Other Names: SC Weekly Injection; Drug: Victoza®; Other Names: daily SC injection
Experimental: Metformin; Metformin only	Drug: 50 mg PB1023; Drug: 70 mg PB1023; Drug: 100 mg PB1023; Drug: Placebo (0.9% Sodium Chloride); Other Names: SC Weekly Injection; Drug: Victoza®; Other Names: daily SC injection
Experimental: Sulfonylurea; Sulfonylurea only	Drug: 50 mg PB1023; Drug: 70 mg PB1023; Drug: 100 mg PB1023; Drug: Placebo (0.9% Sodium Chloride); Other Names: SC Weekly Injection; Drug: Victoza®; Other Names: daily SC injection
Experimental: Metformin and Sulfonylurea; Metformin and Sulfonylurea combination therapy	Drug: 50 mg PB1023; Drug: 70 mg PB1023; Drug: 100 mg PB1023; Drug: Placebo (0.9% Sodium Chloride); Other Names: SC Weekly Injection; Drug: Victoza®; Other Names: daily SC injection
Experimental: PB1023; PB1023 weekly SC injection	Drug: Metformin; Other: Diet and Exercise; Drug: Sulfonylurea; Drug: 50 mg PB1023; Drug: 70 mg PB1023; Drug: 100 mg PB1023; Drug: Metformin and Sulfonylurea
Placebo Comparator: Placebo Comparator; Placebo (0.9% Sodium Chloride) weekly SC injection	Drug: Metformin; Other: Diet and Exercise; Drug: Sulfonylurea; Drug: Placebo (0.9% Sodium Chloride); Other Names: SC Weekly Injection; Drug: Metformin and Sulfonylurea
Active Comparator: Active Comparator; Active Comparator (Victoza) daily SC injection	Drug: Metformin; Other: Diet and Exercise; Drug: Sulfonylurea; Drug: Victoza®; Other Names: daily SC injection; Drug: Metformin and Sulfonylurea

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Description of the incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator	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
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

Collaborators and Investigators

• Sponsor: PhaseBio Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 24, 2012
• First Submitted That Met QC Criteria: August 6, 2012
• First Posted (Estimate): August 7, 2012

Study Record Updates

• Last Update Posted (Estimate): December 7, 2015
• Last Update Submitted That Met QC Criteria: November 5, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide; Metformin
• Other Study ID Numbers: PB1023-PT-CL-0004