A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985293
• Other study ID #: C3421005
• Secondary ID: 2019-000218-12
• Status: Completed
• Phase: Phase 2
• Start date: October 15, 2019
• Est. completion date: July 7, 2021

Study information

• Verified date: June 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: July 7, 2021
• Est. primary completion date: June 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Bulgaria	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
Canada	Aggarwal and Associates Limited	Brampton	Ontario
Canada	Manna Research (Quebec)	Levis	Quebec
Canada	Manna Research (Mirabel)	Mirabel	Quebec
Canada	GA Research Associates Ltd.	Moncton	New Brunswick
Canada	Alpha Recherche Clinique	Quebec
Canada	Centre de Recherche Saint-Louis	Quebec
Canada	Diex Recherche Quebec Inc.	Quebec
Canada	Diex Recherche Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Manna Research (Toronto)	Toronto	Ontario
Canada	Diex Recherche Victoriaville Inc.	Victoriaville	Quebec
Hungary	Belinus Orvosi es Szamitastechnikai Bt	Debrecen
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	CRU Hungary Kft.	Miskolc
Hungary	Borbanya Praxis Egeszsegugyi KFT	Nyiregyhaza
Hungary	Clinfan Kft.	Szekszard
Korea, Republic of	Samsung Medical Center	Gangnam-Gu	Seoul
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Gyeonggi-do
Korea, Republic of	Ajou University Hospital	Suwon-si	Gyeonggi-do
Korea, Republic of	Yonsei University-Wonju Severance Christian Hospital	Wonju-si	Gangwon-do
Poland	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.	Oswiecim
Poland	KO-MED CENTRA KLINICZNE Sp. z o.o. Osrodek Badan Klinicznych w Pulawach	Pulawy
Poland	Centralny Szpital Kliniczny MSWiA	Warszawa
Slovakia	Medispektrum, s.r.o	Bratislava
Slovakia	Metabol KLINIK s.r.o.	Bratislava
Slovakia	HUMAN-CARE, s.r.o.	Kosice
Slovakia	SchronerMED s.r.o.	Moldava nad Bodvou
Slovakia	Funkystuff, s.r.o.	Nove Zamky
Slovakia	DIAB s.r.o.	Roznava
Slovakia	MUDr. Jana Rociakova, s.r.o.	Zilina
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
United States	Ellipsis Group	Alpharetta	Georgia
United States	Cedar Crosse Research Center	Chicago	Illinois
United States	Velocity Clinical Research	Cincinnati	Ohio
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Accel Research Sites - DeLand Clinical Research Unit	DeLand	Florida
United States	Conrad Clinical Research	Edmond	Oklahoma
United States	Lillestol Research LLC	Fargo	North Dakota
United States	PharmQuest	Greensboro	North Carolina
United States	Holy Trinity Medical Clinic	Harbor City	California
United States	Innovative Clinical Research, Inc.	Harbor City	California
United States	Viable Research Management LLC	Henderson	Nevada
United States	Endocrine Associates	Houston	Texas
United States	Juno Research, LLC	Houston	Texas
United States	PrimeCare Medical Group	Houston	Texas
United States	East Coast Institute for Research, LLC	Jacksonville	Florida
United States	East Coast Institute for Research, LLC	Jacksonville	Florida
United States	Family Medical Associates	Levittown	Pennsylvania
United States	Northeast Clinical Research of San Antonio	Live Oak	Texas
United States	Long Beach Clinical Trials Services, Inc.	Long Beach	California
United States	National Research Institute	Los Angeles	California
United States	East Coast Institute for Research, LLC	Macon	Georgia
United States	New Horizon Research Center	Miami	Florida
United States	NewPhase Clinical Trials, Corp.	Miami Beach	Florida
United States	Catalina Research Institute, LLC	Montclair	California
United States	Sunshine Research Center, Inc	Opa-locka	Florida
United States	Andres Patron D.O. P.A.	Pembroke Pines	Florida
United States	Preferred Primary Care Physicians, Inc.	Pittsburgh	Pennsylvania
United States	Empire Clinical Research	Pomona	California
United States	Rancho Cucamonga Clinical Research	Rancho Cucamonga	California
United States	Rainier Clinical Research Center, Inc.	Renton	Washington
United States	Sun Research Institute	San Antonio	Texas
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Encompass Clinical Research	Spring Valley	California
United States	Palmetto Clinical Research	Summerville	South Carolina
United States	Palmetto Primary Care Physicians (physicals only)	Summerville	South Carolina
United States	DM Clinical Research	Tomball	Texas
United States	Martin Diagnostic Clinic	Tomball	Texas
United States	Premier Research	Trenton	New Jersey
United States	University Clinical Investigators, Incorporated	Tustin	California
United States	Buynak Clinical Research	Valparaiso	Indiana
United States	San Fernando Valley Health Institute, LLC	Van Nuys	California
United States	Diablo Clinical Research Incorporated	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Hungary,  Korea, Republic of,  Poland,  Slovakia,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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