Clinical trial NCT01658501: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: PhaseBio Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-07
Enrollment: 593
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Baseline and 20 weeks
Secondary outcomes:
measure: Description of the incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator
timeFrame: Up to 23 weeks
measure: Compare change from baseline in weekly fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator
timeFrame: Baseline and 20 weeks
measure: Describe the frequencies of adverse events in the treatment groups
timeFrame: Up to 23 weeks
measure: Proportion of subjects reaching HbA1c targets (<7.0%) after 20 weeks of dosing
timeFrame: Baseline and 20 weeks
Other outcomes:
Locations:
city: Anniston
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Gulf Shores
country: United States
state: Alabama
city: Huntsville
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state: Alabama
city: Mobile
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state: Alabama
city: Muscle Shoals
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state: Alabama
city: Chandler
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state: Arizona
city: Glendale
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city: Goodyear
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state: Arizona
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state: Arkansas
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state: Arkansas
city: Chula Vista
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state: California
city: Concord
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state: California
city: Escondido
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state: California
city: Hawaiian Gardens
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state: California
city: La Mesa
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state: California
city: Los Angeles
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state: California
city: Oceanside
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state: California
city: San Jose
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state: California
city: Santa Rosa
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state: California
city: Walnut Creek
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state: California
city: Colorado Springs
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state: Colorado
city: Denver
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state: Colorado
city: Stamford
country: United States
state: Connecticut
city: Brandenton
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city: Brooksville
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city: Ft. Lauderdale
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city: Hialeah
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city: Jacksonville
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city: Miami
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city: New Port Richey
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city: Oviedo
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state: Florida
city: St. Petersburg
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state: Florida
city: Tampa
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state: Florida
city: Decatur
country: United States
state: Georgia
city: Marietta
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state: Georgia
city: Roswell
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state: Georgia
city: Savannah
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state: Georgia
city: Boise
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state: Idaho
city: Arlington Heights
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state: Illinois
city: Chicago
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state: Illinois
city: Evansville
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state: Indiana
city: Indianapolis
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state: Indiana
city: Council Bluffs
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state: Iowa
city: Augusta
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state: Kansas
city: Newton
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state: Kansas
city: Overland Park
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state: Kansas
city: Wichita
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state: Kansas
city: New Orleans
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state: Louisiana
city: Oxon Hill
country: United States
state: Maryland
city: Ypsilanti
country: United States
state: Michigan
city: Saint Paul
country: United States
state: Minnesota
city: St. Louis
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state: Missouri
city: Fremont
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state: Nebraska
city: Omaha
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state: Nebraska
city: Las Vegas
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state: Nevada
city: Berlin
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state: New Jersey
city: New Windsor
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state: New York
city: Rochester
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state: New York
city: Charlotte
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state: North Carolina
city: Durham
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state: North Carolina
city: Hickory
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state: North Carolina
city: Morehead City
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state: North Carolina
city: Raleigh
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state: North Carolina
city: Wilmington
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state: North Carolina
city: Winston-Salem
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state: North Carolina
city: Cincinnati
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state: Ohio
city: Cleveland
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city: Delaware
country: United States
state: Ohio
city: Kettering
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city: Lyndhurst
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city: Wadsworth
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state: Ohio
city: Willoughby Hills
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city: Oklahoma City
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city: Tulsa
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state: Oklahoma
city: Eugene
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state: Oregon
city: Greer
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state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
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state: Texas
city: Houston
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state: Texas
city: Hurst
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state: Texas
city: Katy
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state: Texas
city: Magna
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Burke
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Renton
country: United States
state: Washington
city: Kenosha
country: United States
state: Wisconsin
Study officials:
References: