Clinical trial NCT03985293: A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-06-13
Enrollment: 412
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: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels
timeFrame: Baseline, Week 16
measure: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Fasting Plasma Glucose at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Fasting Plasma Glucose at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Fasting Plasma Glucose at Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline in Fasting Plasma Glucose at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Fasting Plasma Glucose at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Fasting Plasma Glucose at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Body Weight at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Body Weight at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Body Weight at Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline in Body Weight at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Body Weight at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Body Weight at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs])
timeFrame: Baseline up to Week 21
measure: Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality
timeFrame: Baseline Through Week 21
measure: Number of Participants With Treatment Emergent Vital Signs Abnormalities
timeFrame: Baseline through Week 21
measure: Number of Participants With Treatment Emergent ECG Abnormalities
timeFrame: Baseline Through Week 21
Other outcomes:
Locations:
city: Harbor City
country: United States
facility: Holy Trinity Medical Clinic
state: California
city: Harbor City
country: United States
facility: Innovative Clinical Research, Inc.
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials Services, Inc.
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: Rancho Cucamonga
country: United States
facility: Rancho Cucamonga Clinical Research
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Incorporated
state: California
city: Van Nuys
country: United States
facility: San Fernando Valley Health Institute, LLC
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research Incorporated
state: California
city: DeLand
country: United States
facility: Accel Research Sites - DeLand Clinical Research Unit
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Miami Beach
country: United States
facility: NewPhase Clinical Trials, Corp.
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Opa-locka
country: United States
facility: Sunshine Research Center, Inc
state: Florida
city: Pembroke Pines
country: United States
facility: Andres Patron D.O. P.A.
state: Florida
city: Alpharetta
country: United States
facility: Ellipsis Group
state: Georgia
city: Macon
country: United States
facility: East Coast Institute for Research, LLC
state: Georgia
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Valparaiso
country: United States
facility: Buynak Clinical Research
state: Indiana
city: Henderson
country: United States
facility: Viable Research Management LLC
state: Nevada
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Cincinnati
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Edmond
country: United States
facility: Conrad Clinical Research
state: Oklahoma
city: Levittown
country: United States
facility: Family Medical Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Inc.
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Primary Care Physicians (physicals only)
state: South Carolina
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Houston
country: United States
facility: Endocrine Associates
state: Texas
city: Houston
country: United States
facility: PrimeCare Medical Group
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC
state: Texas
city: Live Oak
country: United States
facility: Northeast Clinical Research of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center, Inc.
state: Washington
city: Dobrich
country: Bulgaria
facility: MHAT Dobrich AD
city: Dupnitsa
country: Bulgaria
facility: Medical Center ASKLEPII OOD
city: Plovdiv
country: Bulgaria
facility: UMHAT Pulmed
city: Sofia
country: Bulgaria
facility: Fourth MHAT - Sofia EAD
city: Sofia
country: Bulgaria
facility: MHAT "Doverie" AD
city: Stara Zagora
country: Bulgaria
facility: MC "New rehabilitation center" EOOD
city: Moncton
country: Canada
facility: GA Research Associates Ltd.
state: New Brunswick
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: Toronto
country: Canada
facility: Manna Research (Toronto)
state: Ontario
city: Levis
country: Canada
facility: Manna Research (Quebec)
state: Quebec
city: Mirabel
country: Canada
facility: Manna Research (Mirabel)
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc.
state: Quebec
city: Victoriaville
country: Canada
facility: Diex Recherche Victoriaville Inc.
state: Quebec
city: Quebec
country: Canada
facility: Diex Recherche Quebec Inc.
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Debrecen
country: Hungary
facility: Belinus Orvosi es Szamitastechnikai Bt
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Miskolc
country: Hungary
facility: CRU Hungary Kft.
city: Nyiregyhaza
country: Hungary
facility: Borbanya Praxis Egeszsegugyi KFT
city: Szekszard
country: Hungary
facility: Clinfan Kft.
city: Wonju-si
country: Korea, Republic of
facility: Yonsei University-Wonju Severance Christian Hospital
state: Gangwon-do
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Gangnam-Gu
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
city: Bialystok
country: Poland
facility: Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
city: Krakow
country: Poland
facility: Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne DIAB-ENDO-MET Sp. z o. o.
city: Lodz
country: Poland
facility: Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer
city: Oswiecim
country: Poland
facility: MEDICOME Sp. z o.o.
city: Puławy
country: Poland
facility: KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek Badań Klinicznych w Puławach
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA
city: Bratislava
country: Slovakia
facility: Metabol KLINIK s.r.o.
city: Bratislava
country: Slovakia
facility: Medispektrum, s.r.o
city: Kosice
country: Slovakia
facility: HUMAN-CARE, s.r.o.
city: Moldava nad Bodvou
country: Slovakia
facility: SchronerMED s.r.o.
city: Nove Zamky
country: Slovakia
facility: Funkystuff, s.r.o.
city: Roznava
country: Slovakia
facility: DIAB s.r.o.
city: Zilina
country: Slovakia
facility: MUDr. Jana Rociakova, s.r.o.
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: