A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus
NCT ID: NCT03985293
Last Updated: 2022-06-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
412 participants
INTERVENTIONAL
2019-10-15
2021-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
4 matching placebo tablets taken twice a day (BID)
PF-06882961 2.5 milligrams (mg)
PF-06882961
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.
PF-06882961 10 mg
PF-06882961
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.
PF-06882961 40 mg
Participants will be titrated up to 2 weeks to reach desired dose level
PF-06882961
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.
PF-06882961 80 mg
Participants will be titrated up to 4 weeks to reach desired dose level
PF-06882961
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.
PF-06882961 120 mg
Participants will be titrated up to 6 weeks to reach desired dose level
PF-06882961
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.
Interventions
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Placebo
4 matching placebo tablets taken twice a day (BID)
PF-06882961
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
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Holy Trinity Medical Clinic
Harbor City, California, United States
Innovative Clinical Research, Inc.
Harbor City, California, United States
Long Beach Clinical Trials Services, Inc.
Long Beach, California, United States
National Research Institute
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Empire Clinical Research
Pomona, California, United States
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, United States
Encompass Clinical Research
Spring Valley, California, United States
University Clinical Investigators, Incorporated
Tustin, California, United States
San Fernando Valley Health Institute, LLC
Van Nuys, California, United States
Diablo Clinical Research Incorporated
Walnut Creek, California, United States
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
New Horizon Research Center
Miami, Florida, United States
NewPhase Clinical Trials, Corp.
Miami Beach, Florida, United States
Sunshine Research Center, Inc
Opa-locka, Florida, United States
Andres Patron D.O. P.A.
Pembroke Pines, Florida, United States
Ellipsis Group
Alpharetta, Georgia, United States
East Coast Institute for Research, LLC
Macon, Georgia, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Buynak Clinical Research
Valparaiso, Indiana, United States
Viable Research Management LLC
Henderson, Nevada, United States
Premier Research
Trenton, New Jersey, United States
PharmQuest
Greensboro, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Velocity Clinical Research
Cincinnati, Ohio, United States
Conrad Clinical Research
Edmond, Oklahoma, United States
Family Medical Associates
Levittown, Pennsylvania, United States
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
Palmetto Primary Care Physicians (physicals only)
Summerville, South Carolina, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
Endocrine Associates
Houston, Texas, United States
PrimeCare Medical Group
Houston, Texas, United States
Juno Research, LLC
Houston, Texas, United States
Northeast Clinical Research of San Antonio
Live Oak, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
Rainier Clinical Research Center, Inc.
Renton, Washington, United States
MHAT Dobrich AD
Dobrich, , Bulgaria
Medical Center ASKLEPII OOD
Dupnitsa, , Bulgaria
UMHAT Pulmed
Plovdiv, , Bulgaria
Fourth MHAT - Sofia EAD
Sofia, , Bulgaria
MHAT "Doverie" AD
Sofia, , Bulgaria
MC "New rehabilitation center" EOOD
Stara Zagora, , Bulgaria
GA Research Associates Ltd.
Moncton, New Brunswick, Canada
Aggarwal and Associates Limited
Brampton, Ontario, Canada
Manna Research (Toronto)
Toronto, Ontario, Canada
Manna Research (Quebec)
Lévis, Quebec, Canada
Manna Research (Mirabel)
Mirabel, Quebec, Canada
Diex Recherche Quebec Inc.
Québec, Quebec, Canada
Alpha Recherche Clinique
Québec, Quebec, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Diex Recherche Victoriaville Inc.
Victoriaville, Quebec, Canada
Centre de Recherche Saint-Louis
Québec, , Canada
Belinus Orvosi es Szamitastechnikai Bt
Debrecen, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
CRU Hungary Kft.
Miskolc, , Hungary
Borbanya Praxis Egeszsegugyi KFT
Nyíregyháza, , Hungary
Clinfan Kft.
Szekszárd, , Hungary
Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
Bialystok, , Poland
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne DIAB-ENDO-MET Sp. z o. o.
Krakow, , Poland
Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer
Lodz, , Poland
MEDICOME Sp. z o.o.
Oświęcim, , Poland
KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek Badań Klinicznych w Puławach
Puławy, , Poland
Centralny Szpital Kliniczny MSWiA
Warsaw, , Poland
Metabol KLINIK s.r.o.
Bratislava, , Slovakia
Medispektrum, s.r.o
Bratislava, , Slovakia
HUMAN-CARE, s.r.o.
Košice, , Slovakia
SchronerMED s.r.o.
Moldava nad Bodvou, , Slovakia
Funkystuff, s.r.o.
Nové Zámky, , Slovakia
DIAB s.r.o.
Rožňava, , Slovakia
MUDr. Jana Rociakova, s.r.o.
Žilina, , Slovakia
Yonsei University-Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Samsung Medical Center
Gangnam-Gu, Seoul, South Korea
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2019-000218-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C3421005
Identifier Type: -
Identifier Source: org_study_id
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