A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus
A 16-WEEK, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TWICE DAILY PF-06882961 ADMINISTRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED ON METFORMIN OR DIET AND EXERCISE
2 other identifiers
interventional
412
8 countries
83
Brief Summary
This multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise. In addition, the study is intended to enable selection of efficacious doses for future clinical development of PF-06882961.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Oct 2019
Typical duration for phase_2 diabetes-mellitus-type-2
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2019
CompletedFirst Posted
Study publicly available on registry
June 13, 2019
CompletedStudy Start
First participant enrolled
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2021
CompletedResults Posted
Study results publicly available
June 30, 2022
CompletedJune 30, 2022
June 1, 2022
1.6 years
June 11, 2019
June 2, 2022
June 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Baseline, Week 16
Secondary Outcomes (22)
Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels
Baseline, Week 16
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2
Baseline, Week 2
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4
Baseline, Week 4
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6
Baseline, Week 6
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8
Baseline, Week 8
- +17 more secondary outcomes
Study Arms (6)
Placebo
PLACEBO COMPARATORPF-06882961 2.5 milligrams (mg)
EXPERIMENTALPF-06882961 10 mg
EXPERIMENTALPF-06882961 40 mg
EXPERIMENTALParticipants will be titrated up to 2 weeks to reach desired dose level
PF-06882961 80 mg
EXPERIMENTALParticipants will be titrated up to 4 weeks to reach desired dose level
PF-06882961 120 mg
EXPERIMENTALParticipants will be titrated up to 6 weeks to reach desired dose level
Interventions
Participants will be randomized to one of 5 active doses (2.5, 10, 40, 80, or 120 mg), taking 4 tablets twice daily for 16 weeks.
Eligibility Criteria
You may qualify if:
- Patients with T2DM who are treated with metformin and/or diet and exercise
- HbA1c greater than or equal to 7% and less than or equal to 10.5%
- Total body weight \>50 kg (110 lb) with BMI 24.5 to 45.4 kg/m\^2
You may not qualify if:
- Any condition possibly affecting drug absorption
- Diagnosis of Type 1 diabetes
- History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening
- Any malignancy not considered cured
- Personal or family history of MTC or MEN2, or participants with suspected MTC
- Acute pancreatitis or history of chronic pancreatitis
- Symptomatic gallbladder disease
- Known medical history of active proliferative retinopathy and/or macular edema
- Known medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis
- Known history of HIV
- Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
- Clinically relevant ECG abnormalities
- Positive urine drug test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (83)
Holy Trinity Medical Clinic
Harbor City, California, 90710, United States
Innovative Clinical Research, Inc.
Harbor City, California, 90710, United States
Long Beach Clinical Trials Services, Inc.
Long Beach, California, 90806, United States
National Research Institute
Los Angeles, California, 90057, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
Empire Clinical Research
Pomona, California, 91767, United States
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, 91730, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
University Clinical Investigators, Incorporated
Tustin, California, 92780, United States
San Fernando Valley Health Institute, LLC
Van Nuys, California, 91405, United States
Diablo Clinical Research Incorporated
Walnut Creek, California, 94598, United States
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, 32720, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32204, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216, United States
New Horizon Research Center
Miami, Florida, 33165, United States
NewPhase Clinical Trials, Corp.
Miami Beach, Florida, 33140, United States
Sunshine Research Center, Inc
Opa-locka, Florida, 33054, United States
Andres Patron D.O. P.A.
Pembroke Pines, Florida, 33026, United States
Ellipsis Group
Alpharetta, Georgia, 30022, United States
East Coast Institute for Research, LLC
Macon, Georgia, 31210, United States
Cedar Crosse Research Center
Chicago, Illinois, 60607, United States
Buynak Clinical Research
Valparaiso, Indiana, 46383, United States
Viable Research Management LLC
Henderson, Nevada, 89014, United States
Premier Research
Trenton, New Jersey, 08611, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
Lillestol Research LLC
Fargo, North Dakota, 58104, United States
Velocity Clinical Research
Cincinnati, Ohio, 45242, United States
Conrad Clinical Research
Edmond, Oklahoma, 73013, United States
Family Medical Associates
Levittown, Pennsylvania, 19056, United States
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, 15236, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
Palmetto Primary Care Physicians (physicals only)
Summerville, South Carolina, 29485, United States
Dallas Diabetes Research Center
Dallas, Texas, 75230, United States
Endocrine Associates
Houston, Texas, 77004, United States
PrimeCare Medical Group
Houston, Texas, 77024, United States
Juno Research, LLC
Houston, Texas, 77074, United States
Northeast Clinical Research of San Antonio
Live Oak, Texas, 78233, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Martin Diagnostic Clinic
Tomball, Texas, 77375, United States
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057, United States
MHAT Dobrich AD
Dobrich, 9300, Bulgaria
Medical Center ASKLEPII OOD
Dupnitsa, 2600, Bulgaria
UMHAT Pulmed
Plovdiv, 4002, Bulgaria
Fourth MHAT - Sofia EAD
Sofia, 1606, Bulgaria
MHAT "Doverie" AD
Sofia, 1632, Bulgaria
MC "New rehabilitation center" EOOD
Stara Zagora, 6000, Bulgaria
GA Research Associates Ltd.
Moncton, New Brunswick, E1G 1A7, Canada
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1, Canada
Manna Research (Toronto)
Toronto, Ontario, M9W4L6, Canada
Manna Research (Quebec)
Lévis, Quebec, G6W 0M5, Canada
Manna Research (Mirabel)
Mirabel, Quebec, J7J 2K8, Canada
Diex Recherche Quebec Inc.
Québec, Quebec, G1N 4V3, Canada
Alpha Recherche Clinique
Québec, Quebec, G3K2P8, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8, Canada
Diex Recherche Victoriaville Inc.
Victoriaville, Quebec, G6P 6P6, Canada
Centre de Recherche Saint-Louis
Québec, G1W 4R4, Canada
Belinus Orvosi es Szamitastechnikai Bt
Debrecen, 4025, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
CRU Hungary Kft.
Miskolc, 3529, Hungary
Borbanya Praxis Egeszsegugyi KFT
Nyíregyháza, H-4405, Hungary
Clinfan Kft.
Szekszárd, H-7100, Hungary
Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
Bialystok, 15-351, Poland
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne DIAB-ENDO-MET Sp. z o. o.
Krakow, 31-261, Poland
Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer
Lodz, 94-060, Poland
MEDICOME Sp. z o.o.
Oświęcim, 32-600, Poland
KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek Badań Klinicznych w Puławach
Puławy, 24-100, Poland
Centralny Szpital Kliniczny MSWiA
Warsaw, 02-507, Poland
Metabol KLINIK s.r.o.
Bratislava, 811 08, Slovakia
Medispektrum, s.r.o
Bratislava, 851 01, Slovakia
HUMAN-CARE, s.r.o.
Košice, 040 01, Slovakia
SchronerMED s.r.o.
Moldava nad Bodvou, 04501, Slovakia
Funkystuff, s.r.o.
Nové Zámky, 940 01, Slovakia
DIAB s.r.o.
Rožňava, 048 01, Slovakia
MUDr. Jana Rociakova, s.r.o.
Žilina, 010 01, Slovakia
Yonsei University-Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 11923, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Samsung Medical Center
Gangnam-Gu, Seoul, 06351, South Korea
Far Eastern Memorial Hospital
New Taipei City, 220, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Related Publications (1)
Saxena AR, Frias JP, Brown LS, Gorman DN, Vasas S, Tsamandouras N, Birnbaum MJ. Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron for Glycemic Control Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2314493. doi: 10.1001/jamanetworkopen.2023.14493.
PMID: 37213102DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2019
First Posted
June 13, 2019
Study Start
October 15, 2019
Primary Completion
June 8, 2021
Study Completion
July 7, 2021
Last Updated
June 30, 2022
Results First Posted
June 30, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.