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 Glymera Injection Following 20 Weeks of Weekly SC Dosing in Adults With T2DM

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhaseBio Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01658501
First received: July 24, 2012
Last updated: October 18, 2013
Last verified: July 2013
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: 50 mg Glymera
Drug: 70 mg Glymera
Drug: 100 mg Glymera
Drug: Placebo (0.9% Sodium Chloride)
Drug: Victoza®
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Glymera Injection Following 20 Weeks of Once-Weekly Subcutaneous Dosing in Adult Subjects With Inadequately Treated Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by PhaseBio Pharmaceuticals Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline and 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Description of the incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator [ Time Frame: Up to 23 weeks ] [ Designated as safety issue: Yes ]
  • Compare change from baseline in weekly fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator [ Time Frame: Baseline and 20 weeks ] [ Designated as safety issue: No ]
  • Describe the frequencies of adverse events in the treatment groups [ Time Frame: Up to 23 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of subjects reaching HbA1c targets (<7.0%) after 20 weeks of dosing [ Time Frame: Baseline and 20 weeks ] [ Designated as safety issue: No ]

Enrollment: 593
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glymera
Glymera SC Weekly Injection
Drug: 50 mg Glymera Drug: 70 mg Glymera Drug: 100 mg Glymera
Placebo Comparator: Placebo Comparator
Placebo (0.9% Sodium Chloride) - SC Weekly Injection
Drug: Placebo (0.9% Sodium Chloride)
Other Name: SC Weekly Injection
Active Comparator: Active comparator
Active comparator (Victoza®) daily SC injection
Drug: Victoza®
Other Name: daily SC injection

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658501

  Hide Study Locations
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
United States, Arizona
Chandler, Arizona, United States
Glendale, Arizona, United States
Goodyear, Arizona, United States
Tucson, Arizona, United States
United States, Arkansas
Harrisburg, Arkansas, United States
Little Rock, Arkansas, United States
Searcy, Arkansas, United States
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
United States, Colorado
Colorado Springs, Colorado, United States
Denver, Colorado, United States
United States, Connecticut
Stamford, Connecticut, United States
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
United States, Georgia
Decatur, Georgia, United States
Marietta, Georgia, United States
Roswell, Georgia, United States
Savannah, Georgia, United States
United States, Idaho
Boise, Idaho, United States
United States, Illinois
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
Indianapolis, Indiana, United States
United States, Iowa
Council Bluffs, Iowa, United States
United States, Kansas
Augusta, Kansas, United States
Newton, Kansas, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Maryland
Oxon Hill, Maryland, United States
United States, Michigan
Ypsilanti, Michigan, United States
United States, Minnesota
Saint Paul, Minnesota, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Nebraska
Fremont, Nebraska, United States
Omaha, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Berlin, New Jersey, United States
United States, New York
New Windsor, New York, United States
Rochester, New York, United States
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
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
United States, Oklahoma
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
United States, Oregon
Eugene, Oregon, United States
United States, South Carolina
Greer, South Carolina, United States
Spartanburg, South Carolina, United States
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
United States, Utah
Magna, Utah, United States
West Jordan, Utah, United States
United States, Virginia
Burke, Virginia, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
United States, Washington
Renton, Washington, United States
United States, Wisconsin
Kenosha, Wisconsin, United States
Sponsors and Collaborators
PhaseBio Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: PhaseBio Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01658501     History of Changes
Other Study ID Numbers: PB1023-PT-CL-0004
Study First Received: July 24, 2012
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014