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
Public ClinicalTrials.gov record NCT01658501. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01658501
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 593 participants
Conditions and interventions
Conditions
Interventions
- 50 mg PB1023 Drug
- 70 mg PB1023 Drug
- 100 mg PB1023 Drug
- Placebo (0.9% Sodium Chloride) Drug
- Victoza® Drug
- Diet and Exercise Other
- Metformin Drug
- Sulfonylurea Drug
- Metformin and Sulfonylurea Drug
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2012 (Type not available)
- Primary completion
- Jul 2013 (Actual)
- Completion
- Jul 2013 (Actual)
- Last update posted
- Dec 7, 2015
2012 – 2013
United States locations
- U.S. sites
- 93
- U.S. states
- 32
- U.S. cities
- 93
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Anniston | Alabama | — | — |
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Gulf Shores | Alabama | — | — |
| Not listed | Huntsville | Alabama | — | — |
| Not listed | Mobile | Alabama | — | — |
| Not listed | Muscle Shoals | Alabama | — | — |
| Not listed | Chandler | Arizona | — | — |
| Not listed | Glendale | Arizona | — | — |
| Not listed | Goodyear | Arizona | — | — |
| Not listed | Tucson | Arizona | — | — |
| Not listed | Harrisburg | Arkansas | — | — |
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | Searcy | Arkansas | — | — |
| Not listed | Chula Vista | California | — | — |
| Not listed | Concord | California | — | — |
| Not listed | Escondido | California | — | — |
| Not listed | Hawaiian Gardens | California | — | — |
| Not listed | La Mesa | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Oceanside | California | — | — |
| Not listed | San Jose | California | — | — |
| Not listed | Santa Rosa | California | — | — |
| Not listed | Walnut Creek | California | — | — |
| Not listed | Colorado Springs | Colorado | — | — |
| Not listed | Denver | Colorado | — | — |
| Not listed | Stamford | Connecticut | — | — |
| Not listed | Brandenton | Florida | — | — |
| Not listed | Brooksville | Florida | — | — |
| Not listed | Fort Lauderdale | Florida | — | — |
| Not listed | Hialeah | Florida | — | — |
| Not listed | Jacksonville | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | New Port Richey | Florida | — | — |
| Not listed | Oviedo | Florida | — | — |
| Not listed | St. Petersburg | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Decatur | Georgia | — | — |
| Not listed | Marietta | Georgia | — | — |
| Not listed | Roswell | Georgia | — | — |
| Not listed | Savannah | Georgia | — | — |
| Not listed | Boise | Idaho | — | — |
| Not listed | Arlington Heights | Illinois | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Evansville | Indiana | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Council Bluffs | Iowa | — | — |
| Not listed | Augusta | Kansas | — | — |
| Not listed | Newton | Kansas | — | — |
| Not listed | Overland Park | Kansas | — | — |
| Not listed | Wichita | Kansas | — | — |
| Not listed | New Orleans | Louisiana | — | — |
| Not listed | Oxon Hill | Maryland | — | — |
| Not listed | Ypsilanti | Michigan | — | — |
| Not listed | Saint Paul | Minnesota | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Fremont | Nebraska | — | — |
| Not listed | Omaha | Nebraska | — | — |
| Not listed | Las Vegas | Nevada | — | — |
| Not listed | Berlin | New Jersey | — | — |
| Not listed | New Windsor | New York | — | — |
| Not listed | Rochester | New York | — | — |
| Not listed | Charlotte | North Carolina | — | — |
| Not listed | Durham | North Carolina | — | — |
| Not listed | Hickory | North Carolina | — | — |
| Not listed | Morehead City | North Carolina | — | — |
| Not listed | Raleigh | North Carolina | — | — |
| Not listed | Wilmington | North Carolina | — | — |
| Not listed | Winston-Salem | North Carolina | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Cleveland | Ohio | — | — |
| Not listed | Delaware | Ohio | — | — |
| Not listed | Kettering | Ohio | — | — |
| Not listed | Lyndhurst | Ohio | — | — |
| Not listed | Wadsworth | Ohio | — | — |
| Not listed | Willoughby Hills | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Tulsa | Oklahoma | — | — |
| Not listed | Eugene | Oregon | — | — |
| Not listed | Greer | South Carolina | — | — |
| Not listed | Spartanburg | South Carolina | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Corpus Christi | Texas | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Hurst | Texas | — | — |
| Not listed | Katy | Texas | — | — |
| Not listed | Magna | Utah | — | — |
| Not listed | West Jordan | Utah | — | — |
| Not listed | Burke | Virginia | — | — |
| Not listed | Richmond | Virginia | — | — |
| Not listed | Virginia Beach | Virginia | — | — |
| Not listed | Renton | Washington | — | — |
| Not listed | Kenosha | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01658501, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 7, 2015 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01658501 live on ClinicalTrials.gov.