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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

Sponsor
PhaseBio Pharmaceuticals Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01658501
Collaborator
(none)
593
Enrollment
93
Locations
7
Arms
12
Duration (Months)
6.4
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
593 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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 (PB1023) Injection Following 20 Weeks of Once-Weekly Subcutaneous Dosing in Adult Subjects With Inadequately Treated Type 2 Diabetes Mellitus
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

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: 50 mg PB1023

    Drug: 70 mg PB1023

    Drug: 100 mg PB1023

    Other: Diet and Exercise

    Drug: Metformin

    Drug: Sulfonylurea

    Drug: Metformin and Sulfonylurea
    Placebo Comparator: Placebo Comparator

    Placebo (0.9% Sodium Chloride) weekly SC injection

    Drug: Placebo (0.9% Sodium Chloride)
    Other Names:
  • SC Weekly Injection

    • Other: Diet and Exercise

    Drug: Metformin

    Drug: Sulfonylurea

    Drug: Metformin and Sulfonylurea
    Active Comparator: Active Comparator

    Active Comparator (Victoza) daily SC injection

    Drug: Victoza®
    Other Names:
  • daily SC injection

    • Other: Diet and Exercise

    Drug: Metformin

    Drug: Sulfonylurea

    Drug: Metformin and Sulfonylurea

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Description of the incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator [Up to 23 weeks]

    2. 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]

    3. Describe the frequencies of adverse events in the treatment groups [Up to 23 weeks]

    4. Proportion of subjects reaching HbA1c targets (<7.0%) after 20 weeks of dosing [Baseline and 20 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anniston Alabama United States
    2 Birmingham Alabama United States
    3 Gulf Shores Alabama United States
    4 Huntsville Alabama United States
    5 Mobile Alabama United States
    6 Muscle Shoals Alabama United States
    7 Chandler Arizona United States
    8 Glendale Arizona United States
    9 Goodyear Arizona United States
    10 Tucson Arizona United States
    11 Harrisburg Arkansas United States
    12 Little Rock Arkansas United States
    13 Searcy Arkansas United States
    14 Chula Vista California United States
    15 Concord California United States
    16 Escondido California United States
    17 Hawaiian Gardens California United States
    18 La Mesa California United States
    19 Los Angeles California United States
    20 Oceanside California United States
    21 San Jose California United States
    22 Santa Rosa California United States
    23 Walnut Creek California United States
    24 Colorado Springs Colorado United States
    25 Denver Colorado United States
    26 Stamford Connecticut United States
    27 Brandenton Florida United States
    28 Brooksville Florida United States
    29 Ft. Lauderdale Florida United States
    30 Hialeah Florida United States
    31 Jacksonville Florida United States
    32 Miami Florida United States
    33 New Port Richey Florida United States
    34 Oviedo Florida United States
    35 St. Petersburg Florida United States
    36 Tampa Florida United States
    37 Decatur Georgia United States
    38 Marietta Georgia United States
    39 Roswell Georgia United States
    40 Savannah Georgia United States
    41 Boise Idaho United States
    42 Arlington Heights Illinois United States
    43 Chicago Illinois United States
    44 Evansville Indiana United States
    45 Indianapolis Indiana United States
    46 Council Bluffs Iowa United States
    47 Augusta Kansas United States
    48 Newton Kansas United States
    49 Overland Park Kansas United States
    50 Wichita Kansas United States
    51 New Orleans Louisiana United States
    52 Oxon Hill Maryland United States
    53 Ypsilanti Michigan United States
    54 Saint Paul Minnesota United States
    55 St. Louis Missouri United States
    56 Fremont Nebraska United States
    57 Omaha Nebraska United States
    58 Las Vegas Nevada United States
    59 Berlin New Jersey United States
    60 New Windsor New York United States
    61 Rochester New York United States
    62 Charlotte North Carolina United States
    63 Durham North Carolina United States
    64 Hickory North Carolina United States
    65 Morehead City North Carolina United States
    66 Raleigh North Carolina United States
    67 Wilmington North Carolina United States
    68 Winston-Salem North Carolina United States
    69 Cincinnati Ohio United States
    70 Cleveland Ohio United States
    71 Delaware Ohio United States
    72 Kettering Ohio United States
    73 Lyndhurst Ohio United States
    74 Wadsworth Ohio United States
    75 Willoughby Hills Ohio United States
    76 Oklahoma City Oklahoma United States
    77 Tulsa Oklahoma United States
    78 Eugene Oregon United States
    79 Greer South Carolina United States
    80 Spartanburg South Carolina United States
    81 Austin Texas United States
    82 Corpus Christi Texas United States
    83 Dallas Texas United States
    84 Houston Texas United States
    85 Hurst Texas United States
    86 Katy Texas United States
    87 Magna Utah United States
    88 West Jordan Utah United States
    89 Burke Virginia United States
    90 Richmond Virginia United States
    91 Virginia Beach Virginia United States
    92 Renton Washington United States
    93 Kenosha Wisconsin United States

    Sponsors and Collaborators

    • PhaseBio Pharmaceuticals Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    PhaseBio Pharmaceuticals Inc.
    ClinicalTrials.gov Identifier:
    NCT01658501
    Other Study ID Numbers:
    • PB1023-PT-CL-0004
    First Posted:
    Aug 7, 2012
    Last Update Posted:
    Dec 7, 2015
    Last Verified:
    Nov 1, 2015
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Metformin
    Liraglutide

    Study Results

    No Results Posted as of Dec 7, 2015