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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: PF-06882961

• Study Type: Interventional
• Enrollment (Actual): 412
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Dobrich, Bulgaria, 9300
    • MHAT Dobrich AD
  • Dupnitsa, Bulgaria, 2600
    • Medical Center Asklepii Ood
  • Plovdiv, Bulgaria, 4002
    • UMHAT Pulmed
  • Sofia, Bulgaria, 1606
    • Fourth MHAT - Sofia EAD
  • Sofia, Bulgaria, 1632
    • MHAT "Doverie" AD
  • Stara Zagora, Bulgaria, 6000
    • MC "New rehabilitation center" EOOD
• Canada
  • Quebec, Canada, G1W 4R4
    • Centre de Recherche Saint-Louis
  • Quebec, Canada, G1N 4V3
    • Diex Recherche Quebec Inc.
  • Quebec, Canada, G3K2P8
    • Alpha Recherche Clinique
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • GA Research Associates Ltd.
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates Limited
    • Toronto, Ontario, Canada, M9W4L6
      • Manna Research (Toronto)
  • Quebec
    • Levis, Quebec, Canada, G6W 0M5
      • Manna Research (Quebec)
    • Mirabel, Quebec, Canada, J7J 2K8
      • Manna Research (Mirabel)
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Diex Recherche Sherbrooke Inc.
    • Victoriaville, Quebec, Canada, G6P 6P6
      • Diex Recherche Victoriaville Inc.
• Hungary
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Debrecen, Hungary, 4025
    • Belinus Orvosi és Számitástechnikai Bt
  • Miskolc, Hungary, 3529
    • CRU Hungary Kft.
  • Nyiregyhaza, Hungary, H-4405
    • Borbanya Praxis Egeszsegugyi KFT
  • Szekszard, Hungary, H-7100
    • Clinfan Kft.
• Korea, Republic of
  • Gangwon-do
    • Wonju-si, Gangwon-do, Korea, Republic of, 26426
      • Yonsei University-Wonju Severance Christian Hospital
  • Gyeonggi-do
    • Guri-si, Gyeonggi-do, Korea, Republic of, 11923
      • Hanyang University Guri Hospital
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital
  • Seoul
    • Gangnam-Gu, Seoul, Korea, Republic of, 06351
      • Samsung Medical Center
• Poland
  • Bialystok, Poland, 15-351
    • ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
  • Krakow, Poland, 31-261
    • Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne DIAB-ENDO-MET Sp. z o. o.
  • Lodz, Poland, 94-060
    • Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer
  • Oswiecim, Poland, 32-600
    • Medicome Sp. z o.o.
  • Puławy, Poland, 24-100
    • KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek Badań Klinicznych w Puławach
  • Warszawa, Poland, 02-507
    • Centralny Szpital Kliniczny Mswia
• Slovakia
  • Bratislava, Slovakia, 851 01
    • Medispektrum, s.r.o
  • Bratislava, Slovakia, 811 08
    • Metabol KLINIK s.r.o.
  • Kosice, Slovakia, 040 01
    • HUMAN-CARE, s.r.o.
  • Moldava nad Bodvou, Slovakia, 04501
    • SchronerMED s.r.o.
  • Nove Zamky, Slovakia, 940 01
    • FUNKYSTUFF, s.r.o.
  • Roznava, Slovakia, 048 01
    • DIAB s.r.o.
  • Zilina, Slovakia, 010 01
    • MUDr. Jana Rociakova, s.r.o.
• Taiwan
  • New Taipei City, Taiwan, 220
    • Far Eastern Memorial Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
• United States
  • California
    • Harbor City, California, United States, 90710
      • Holy Trinity Medical Clinic
    • Harbor City, California, United States, 90710
      • Innovative Clinical Research, Inc.
    • Long Beach, California, United States, 90806
      • Long Beach Clinical Trials Services, Inc.
    • Los Angeles, California, United States, 90057
      • National Research Institute
    • Montclair, California, United States, 91763
      • Catalina Research Institute, LLC
    • Pomona, California, United States, 91767
      • Empire Clinical Research
    • Rancho Cucamonga, California, United States, 91730
      • Rancho Cucamonga Clinical Research
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
    • Tustin, California, United States, 92780
      • University Clinical Investigators, Incorporated
    • Van Nuys, California, United States, 91405
      • San Fernando Valley Health Institute, LLC
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research Incorporated
  • Florida
    • DeLand, Florida, United States, 32720
      • Accel Research Sites - DeLand Clinical Research Unit
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research, LLC
    • Jacksonville, Florida, United States, 32204
      • East Coast Institute for Research, LLC
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • Miami Beach, Florida, United States, 33140
      • NewPhase Clinical Trials, Corp.
    • Opa-locka, Florida, United States, 33054
      • Sunshine Research Center, Inc
    • Pembroke Pines, Florida, United States, 33026
      • Andres Patron D.O. P.A.
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Ellipsis Group
    • Macon, Georgia, United States, 31210
      • East Coast Institute for Research, LLC
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Cedar Crosse Research Center
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Buynak Clinical Research
  • Nevada
    • Henderson, Nevada, United States, 89014
      • Viable Research Management LLC
  • New Jersey
    • Trenton, New Jersey, United States, 08611
      • Premier Research
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Velocity Clinical Research
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Conrad Clinical Research
  • Pennsylvania
    • Levittown, Pennsylvania, United States, 19056
      • Family Medical Associates
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians, Inc.
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
    • Summerville, South Carolina, United States, 29485
      • Palmetto Clinical Research
    • Summerville, South Carolina, United States, 29485
      • Palmetto Primary Care Physicians (physicals only)
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes Research Center
    • Houston, Texas, United States, 77074
      • Juno Research, LLC
    • Houston, Texas, United States, 77004
      • Endocrine Associates
    • Houston, Texas, United States, 77024
      • PrimeCare Medical Group
    • Live Oak, Texas, United States, 78233
      • Northeast Clinical Research of San Antonio
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute
    • Tomball, Texas, United States, 77375
      • Martin Diagnostic Clinic
    • Tomball, Texas, United States, 77375
      • DM Clinical Research
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 4 matching placebo tablets taken twice a day (BID)
Experimental: PF-06882961 2.5 milligrams (mg)	Drug: 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.
Experimental: PF-06882961 10 mg	Drug: 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.
Experimental: PF-06882961 40 mg; Participants will be titrated up to 2 weeks to reach desired dose level	Drug: 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.
Experimental: PF-06882961 80 mg; Participants will be titrated up to 4 weeks to reach desired dose level	Drug: 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.
Experimental: PF-06882961 120 mg; Participants will be titrated up to 6 weeks to reach desired dose level	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels	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
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2	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 2
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4	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 4
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6	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 6
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8	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 8
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12	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 12
Change From Baseline in Fasting Plasma Glucose at Week 2	The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 milligram per deciliter (mg/dL) to 99 mg/dL.	Baseline, Week 2
Change From Baseline in Fasting Plasma Glucose at Week 4	The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.	Baseline, Week 4
Change From Baseline in Fasting Plasma Glucose at Week 6	The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.	Baseline, Week 6
Change From Baseline in Fasting Plasma Glucose at Week 8	The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.	Baseline, Week 8
Change From Baseline in Fasting Plasma Glucose at Week 12	The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.	Baseline, Week 12
Change From Baseline in Fasting Plasma Glucose at Week 16	The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.	Baseline, Week 16
Change From Baseline in Body Weight at Week 2	Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.	Baseline, Week 2
Change From Baseline in Body Weight at Week 4	Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.	Baseline, Week 4
Change From Baseline in Body Weight at Week 6	Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.	Baseline, Week 6
Change From Baseline in Body Weight at Week 8	Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.	Baseline, Week 8
Change From Baseline in Body Weight at Week 12	Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.	Baseline, Week 12
Change From Baseline in Body Weight at Week 16	Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.	Baseline, Week 16
Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs])	An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.	Baseline up to Week 21
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality	Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time, PT/INR, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin); lipid panel (low density lipoprotein cholesterol, high density lipoprotein cholesterol).	Baseline Through Week 21
Number of Participants With Treatment Emergent Vital Signs Abnormalities	Vital signs abnormality criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP >= 20 mmHg.	Baseline through Week 21
Number of Participants With Treatment Emergent ECG Abnormalities	ECG categorical abnormality criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (>=) 300 millisecond (msec), b) >=25% increase when baseline is > 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec. 2. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) >=140 msec, b) >=50% increase from baseline. 3. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and <=480 msec, b) >480 msec and <=500 msec, c) >500 msec, d) >30 msec and <=60 msec increase from baseline, e) >60 msec increase from baseline.	Baseline Through Week 21

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): June 8, 2021
• Study Completion (Actual): July 7, 2021

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 13, 2019

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: C3421005; 2019-000218-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No