Diabetes Mellitus, Type 2Phase 2NCT03985293
A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus
A Phase 2 study testing PF-06882961 in people with Diabetes Mellitus, Type 2, run by Pfizer at 83 sites in 8 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- PF-06882961
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 412 participants
- Where
- 83 sitesin 8 countries
- Study dates
- 15 Oct 2019to 7 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
83 sites in 8 countries.
83 sites in 8 countries
United States42 sites
Ellipsis Group
Alpharetta, Georgia, 30022
Cedar Crosse Research Center
Chicago, Illinois, 60607
Velocity Clinical Research
Cincinnati, Ohio, 45242
Dallas Diabetes Research Center
Dallas, Texas, 75230
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, 32720
Conrad Clinical Research
Edmond, Oklahoma, 73013
Lillestol Research LLC
Fargo, North Dakota, 58104
PharmQuest
Greensboro, North Carolina, 27408
Holy Trinity Medical Clinic
Harbor City, California, 90710
Innovative Clinical Research, Inc.
Harbor City, California, 90710
Viable Research Management LLC
Henderson, Nevada, 89014
Endocrine Associates
Houston, Texas, 77004
PrimeCare Medical Group
Houston, Texas, 77024
Juno Research, LLC
Houston, Texas, 77074
East Coast Institute for Research, LLC
Jacksonville, Florida, 32204
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216
Family Medical Associates
Levittown, Pennsylvania, 19056
Northeast Clinical Research of San Antonio
Live Oak, Texas, 78233
Long Beach Clinical Trials Services, Inc.
Long Beach, California, 90806
National Research Institute
Los Angeles, California, 90057
East Coast Institute for Research, LLC
Macon, Georgia, 31210
New Horizon Research Center
Miami, Florida, 33165
NewPhase Clinical Trials, Corp.
Miami Beach, Florida, 33140
Catalina Research Institute, LLC
Montclair, California, 91763
Sunshine Research Center, Inc
Opa-locka, Florida, 33054
Andres Patron D.O. P.A.
Pembroke Pines, Florida, 33026
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, 15236
Empire Clinical Research
Pomona, California, 91767
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, 91730
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057
Sun Research Institute
San Antonio, Texas, 78215
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Encompass Clinical Research
Spring Valley, California, 91978
Palmetto Clinical Research
Summerville, South Carolina, 29485
Palmetto Primary Care Physicians (physicals only)
Summerville, South Carolina, 29485
DM Clinical Research
Tomball, Texas, 77375
Martin Diagnostic Clinic
Tomball, Texas, 77375
Premier Research
Trenton, New Jersey, 08611
University Clinical Investigators, Incorporated
Tustin, California, 92780
Buynak Clinical Research
Valparaiso, Indiana, 46383
San Fernando Valley Health Institute, LLC
Van Nuys, California, 91405
Diablo Clinical Research Incorporated
Walnut Creek, California, 94598
Canada10 sites
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1
Manna Research (Quebec)
Lévis, Quebec, G6W 0M5
Manna Research (Mirabel)
Mirabel, Quebec, J7J 2K8
GA Research Associates Ltd.
Moncton, New Brunswick, E1G 1A7
Diex Recherche Quebec Inc.
Québec, Quebec, G1N 4V3
Alpha Recherche Clinique
Québec, Quebec, G3K2P8
Centre de Recherche Saint-Louis
Québec, G1W 4R4
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8
Manna Research (Toronto)
Toronto, Ontario, M9W4L6
Diex Recherche Victoriaville Inc.
Victoriaville, Quebec, G6P 6P6
Slovakia7 sites
Metabol KLINIK s.r.o.
Bratislava, 811 08
Medispektrum, s.r.o
Bratislava, 851 01
HUMAN-CARE, s.r.o.
Košice, 040 01
SchronerMED s.r.o.
Moldava nad Bodvou, 04501
Funkystuff, s.r.o.
Nové Zámky, 940 01
DIAB s.r.o.
Rožňava, 048 01
MUDr. Jana Rociakova, s.r.o.
Žilina, 010 01
Bulgaria6 sites
MHAT Dobrich AD
Dobrich, 9300
Medical Center ASKLEPII OOD
Dupnitsa, 2600
UMHAT Pulmed
Plovdiv, 4002
Fourth MHAT - Sofia EAD
Sofia, 1606
MHAT "Doverie" AD
Sofia, 1632
MC "New rehabilitation center" EOOD
Stara Zagora, 6000
Poland6 sites
Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
Bialystok, 15-351
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne DIAB-ENDO-MET Sp. z o. o.
Krakow, 31-261
Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer
Lodz, 94-060
MEDICOME Sp. z o.o.
Oświęcim, 32-600
KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek Badań Klinicznych w Puławach
Puławy, 24-100
Centralny Szpital Kliniczny MSWiA
Warsaw, 02-507
Hungary5 sites
Belinus Orvosi es Szamitastechnikai Bt
Debrecen, 4025
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
CRU Hungary Kft.
Miskolc, 3529
Borbanya Praxis Egeszsegugyi KFT
Nyíregyháza, H-4405
Clinfan Kft.
Szekszárd, H-7100
South Korea4 sites
Samsung Medical Center
Gangnam-Gu, Seoul, 06351
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 11923
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
Yonsei University-Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Taiwan3 sites
Far Eastern Memorial Hospital
New Taipei City, 220
Taichung Veterans General Hospital
Taichung, 40705
National Cheng Kung University Hospital
Tainan, 704
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Placebo, PF-06882961
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
4 matching placebo tablets taken twice a day (BID)
PF-06882961Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| PF-06882961 2.5 milligrams (mg) | Experimental | Not described Receives: Drug: PF-06882961 |
| PF-06882961 10 mg | Experimental | Not described Receives: Drug: PF-06882961 |
| PF-06882961 40 mg | Experimental | Participants will be titrated up to 2 weeks to reach desired dose level Receives: Drug: PF-06882961 |
| PF-06882961 80 mg | Experimental | Participants will be titrated up to 4 weeks to reach desired dose level Receives: Drug: PF-06882961 |
| PF-06882961 120 mg | Experimental | Participants will be titrated up to 6 weeks to reach desired dose level Receives: Drug: PF-06882961 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Baseline, Week 16
Secondary outcomes (22)
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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
- 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.
- 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.
Measured: Baseline Through Week 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start15 Oct 2019
- Primary completion8 Jun 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985293
- Sponsor's protocol ID
- C3421005
- Other IDs
- 2019-000218-12, 2019
- Status last verified
- Jun 2022
- First submitted
- 11 Jun 2019
- Last updated
- 30 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37213102
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03985293
- Acronym / sponsor ID
- C3421005
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Posted 30 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| PF-06882961 2.5 milligrams (mg) | Experimental | Drug: PF-06882961 |
| PF-06882961 10 mg | Experimental | Drug: PF-06882961 |
| PF-06882961 40 mg | Experimental | Drug: PF-06882961Participants will be titrated up to 2 weeks to reach desired dose level |
| PF-06882961 80 mg | Experimental | Drug: PF-06882961Participants will be titrated up to 4 weeks to reach desired dose level |
| PF-06882961 120 mg | Experimental | Drug: PF-06882961Participants will be titrated up to 6 weeks to reach desired dose level |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo4 matching placebo tablets taken twice a day (BID) | Drug | Placebo |
| PF-06882961Participants 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. | Drug | PF-06882961 10 mg, PF-06882961 120 mg, PF-06882961 2.5 milligrams (mg), PF-06882961 40 mg, PF-06882961 80 mg |
Primary outcome
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16
Time frame: Baseline, 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%.
22 secondary outcomes
Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels
Time frame: Baseline, Week 16
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2
Time frame: Baseline, Week 2
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6
Time frame: Baseline, Week 6
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Fasting Plasma Glucose at Week 2
Time frame: Baseline, Week 2
Change From Baseline in Fasting Plasma Glucose at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Fasting Plasma Glucose at Week 6
Time frame: Baseline, Week 6
Change From Baseline in Fasting Plasma Glucose at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Fasting Plasma Glucose at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Fasting Plasma Glucose at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Body Weight at Week 2
Time frame: Baseline, Week 2
Change From Baseline in Body Weight at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Body Weight at Week 6
Time frame: Baseline, Week 6
Change From Baseline in Body Weight at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Body Weight at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Body Weight at Week 16
Time frame: Baseline, Week 16
Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs])
Time frame: Baseline up to Week 21
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality
Time frame: Baseline Through Week 21
Number of Participants With Treatment Emergent Vital Signs Abnormalities
Time frame: Baseline through Week 21
Number of Participants With Treatment Emergent ECG Abnormalities
Time frame: Baseline Through Week 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37213102Saxena 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
83 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-06882961 in people with Diabetes Mellitus, Type 2, run by Pfizer at 83 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in United States, Canada, Slovakia, Bulgaria, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16 (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03985293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.