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
Overview[ - collapse ][ - ]
| 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 | Type 2 Diabetes Mellitus |
| Intervention | Drug: 50 mg Glymera Drug: 70 mg Glymera Drug: 100 mg Glymera Drug: Placebo (0.9% Sodium Chloride) Drug: Victoza® |
| Phase | Phase 2 |
| Sponsor | PhaseBio Pharmaceuticals Inc. |
| Responsible Party | PhaseBio Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier | NCT01658501 |
| First Received | July 24, 2012 |
| Last Updated | October 18, 2013 |
| Last verified | July 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 24, 2012 |
|---|---|
| Last Updated Date | October 18, 2013 |
| Start Date | July 2012 |
| Estimated Primary Completion Date | July 2013 |
| Current 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] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
|---|---|
| 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 |
| 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 Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: 50 mg Glymera Drug: 70 mg Glymera Drug: 100 mg Glymera Drug: Placebo (0.9% Sodium Chloride) Other Names: SC Weekly InjectionDrug: Victoza® Other Names: daily SC injection |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 593 |
| Estimated Completion Date | July 2013 |
| Estimated Primary Completion Date | July 2013 |
| 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01658501 |
|---|---|
| Other Study ID Numbers | PB1023-PT-CL-0004 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | PhaseBio Pharmaceuticals Inc. |
| Study Sponsor | PhaseBio Pharmaceuticals Inc. |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | July 2013 |
Locations[ + expand ][ + ]
| United States, Alabama | Anniston, Alabama, United States |
|---|---|
| United States, Alabama | Birmingham, Alabama, United States |
| United States, Alabama | Gulf Shores, Alabama, United States |
| United States, Alabama | Huntsville, Alabama, United States |
| United States, Alabama | Mobile, Alabama, United States |
| United States, Alabama | Muscle Shoals, Alabama, United States |
| United States, Arizona | Chandler, Arizona, United States |
| United States, Arizona | Glendale, Arizona, United States |
| United States, Arizona | Goodyear, Arizona, United States |
| United States, Arizona | Tucson, Arizona, United States |
| United States, Arkansas | Harrisburg, Arkansas, United States |
| United States, Arkansas | Little Rock, Arkansas, United States |
| United States, Arkansas | Searcy, Arkansas, United States |
| United States, California | Chula Vista, California, United States |
| United States, California | Concord, California, United States |
| United States, California | Escondido, California, United States |
| United States, California | Hawaiian Gardens, California, United States |
| United States, California | La Mesa, California, United States |
| United States, California | Los Angeles, California, United States |
| United States, California | Oceanside, California, United States |
| United States, California | San Jose, California, United States |
| United States, California | Santa Rosa, California, United States |
| United States, California | Walnut Creek, California, United States |
| United States, Colorado | Colorado Springs, Colorado, United States |
| United States, Colorado | Denver, Colorado, United States |
| United States, Connecticut | Stamford, Connecticut, United States |
| United States, Florida | Brandenton, Florida, United States |
| United States, Florida | Brooksville, Florida, United States |
| United States, Florida | Ft. Lauderdale, Florida, United States |
| United States, Florida | Hialeah, Florida, United States |
| United States, Florida | Jacksonville, Florida, United States |
| United States, Florida | Miami, Florida, United States |
| United States, Florida | New Port Richey, Florida, United States |
| United States, Florida | Oviedo, Florida, United States |
| United States, Florida | St. Petersburg, Florida, United States |
| United States, Florida | Tampa, Florida, United States |
| United States, Georgia | Decatur, Georgia, United States |
| United States, Georgia | Marietta, Georgia, United States |
| United States, Georgia | Roswell, Georgia, United States |
| United States, Georgia | Savannah, Georgia, United States |
| United States, Idaho | Boise, Idaho, United States |
| United States, Illinois | Arlington Heights, Illinois, United States |
| United States, Illinois | Chicago, Illinois, United States |
| United States, Indiana | Evansville, Indiana, United States |
| United States, Indiana | Indianapolis, Indiana, United States |
| United States, Iowa | Council Bluffs, Iowa, United States |
| United States, Kansas | Augusta, Kansas, United States |
| United States, Kansas | Newton, Kansas, United States |
| United States, Kansas | Overland Park, Kansas, United States |
| United States, Kansas | 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 |
| United States, Nebraska | 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 |
| United States, New York | Rochester, New York, United States |
| United States, North Carolina | Charlotte, North Carolina, United States |
| United States, North Carolina | Durham, North Carolina, United States |
| United States, North Carolina | Hickory, North Carolina, United States |
| United States, North Carolina | Morehead City, North Carolina, United States |
| United States, North Carolina | Raleigh, North Carolina, United States |
| United States, North Carolina | Wilmington, North Carolina, United States |
| United States, North Carolina | Winston-Salem, North Carolina, United States |
| United States, Ohio | Cincinnati, Ohio, United States |
| United States, Ohio | Cleveland, Ohio, United States |
| United States, Ohio | Delaware, Ohio, United States |
| United States, Ohio | Kettering, Ohio, United States |
| United States, Ohio | Lyndhurst, Ohio, United States |
| United States, Ohio | Wadsworth, Ohio, United States |
| United States, Ohio | Willoughby Hills, Ohio, United States |
| United States, Oklahoma | Oklahoma City, Oklahoma, United States |
| United States, Oklahoma | Tulsa, Oklahoma, United States |
| United States, Oregon | Eugene, Oregon, United States |
| United States, South Carolina | Greer, South Carolina, United States |
| United States, South Carolina | Spartanburg, South Carolina, United States |
| United States, Texas | Austin, Texas, United States |
| United States, Texas | Corpus Christi, Texas, United States |
| United States, Texas | Dallas, Texas, United States |
| United States, Texas | Houston, Texas, United States |
| United States, Texas | Hurst, Texas, United States |
| United States, Texas | Katy, Texas, United States |
| United States, Utah | Magna, Utah, United States |
| United States, Utah | West Jordan, Utah, United States |
| United States, Virginia | Burke, Virginia, United States |
| United States, Virginia | Richmond, Virginia, United States |
| United States, Virginia | Virginia Beach, Virginia, United States |
| United States, Washington | Renton, Washington, United States |
| United States, Wisconsin | Kenosha, Wisconsin, United States |