4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ESCALATING ORAL DOSES OF PF-06882961 IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS
1 other identifier
interventional
98
1 country
4
Brief Summary
This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants will receive an investigational product or placebo for 28 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 type-2-diabetes-mellitus
Started Jun 2018
Typical duration for phase_1 type-2-diabetes-mellitus
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2018
CompletedFirst Posted
Study publicly available on registry
May 29, 2018
CompletedStudy Start
First participant enrolled
June 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2019
CompletedResults Posted
Study results publicly available
July 1, 2020
CompletedJuly 1, 2020
June 1, 2020
11 months
May 7, 2018
May 8, 2020
June 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study treatment in a participant who received 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.
From baseline to up to 35 days after last dose for a total of approximately 63 days
Number of Participants With 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 \[PT\], PT/international normalized ratio, 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).
From baseline to up to 14 days after last dose for a total of approximately 42 days
Number of Participants With Abnormal Vital Signs
Vital signs categorical summarization 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.
From baseline to up to 14 days after last dose for a total of approximately 42 days
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
ECG categorical summarization 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 duration (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
From baseline to up to 14 days after last dose for a total of approximately 42 days
Secondary Outcomes (7)
AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 28
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
Terminal Half-life (t½) of PF-06882961 on Day 28
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28
Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28
0 to 24 hours post-dose on Day 28
- +2 more secondary outcomes
Study Arms (9)
Placebo
PLACEBO COMPARATORPF-06882961 30 mg
EXPERIMENTALPF-06882961 100 mg
EXPERIMENTALPF-06882961 300 mg
EXPERIMENTALPF-06882961 600 mg
EXPERIMENTALPF-06882961 dose TBD Cohort 5
EXPERIMENTALPF-06882961 dose TBD Cohort 6
EXPERIMENTALPF-06882961 dose TBD Cohort 7
EXPERIMENTALPF-06882961 dose TBD Cohort 8
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes treated with a stable dose of metformin at least 500 mg
- HbA1c value between 7.0 and 10.5%
You may not qualify if:
- \- Type 1 diabetes or secondary forms of diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (4)
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Qps-Mra, Llc
South Miami, Florida, 33143, United States
Qps-Mra,Llc
South Miami, Florida, 33143, United States
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212, United States
Related Publications (1)
Saxena AR, Gorman DN, Esquejo RM, Bergman A, Chidsey K, Buckeridge C, Griffith DA, Kim AM. Danuglipron (PF-06882961) in type 2 diabetes: a randomized, placebo-controlled, multiple ascending-dose phase 1 trial. Nat Med. 2021 Jun;27(6):1079-1087. doi: 10.1038/s41591-021-01391-w. Epub 2021 Jun 14.
PMID: 34127852DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2018
First Posted
May 29, 2018
Study Start
June 25, 2018
Primary Completion
May 23, 2019
Study Completion
June 10, 2019
Last Updated
July 1, 2020
Results First Posted
July 1, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share
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.