4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes
NCT ID: NCT03538743
Last Updated: 2020-07-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
98 participants
INTERVENTIONAL
2018-06-25
2019-06-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of the Safety and Efficacy of MK-3577 in Participants With Type 2 Diabetes Mellitus (MK-3577-009)
NCT00868790
A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY
NCT04617275
12 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With Metformin
NCT00473525
A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)
NCT00511667
A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin
NCT02554877
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo
Tablet, 0 mg, twice daily, 28 days
PF-06882961 30 mg
PF-06882961
Tablet, 15 mg twice daily, 28 days
PF-06882961 100 mg
PF-06882961
Tablet, 50 mg twice daily, 28 days
PF-06882961 300 mg
PF-06882961
Tablet, 150 mg twice daily, 28 days
PF-06882961 600 mg
PF-06882961
Tablet, 300 mg twice daily, 28 days
PF-06882961 dose TBD Cohort 5
PF-06882961
Tablet, dose TBD, twice daily, Cohort 5, 28 days
PF-06882961 dose TBD Cohort 6
PF-06882961
Tablet, dose TBD, twice daily, Cohort 6, 28 days
PF-06882961 dose TBD Cohort 7
PF-06882961
Tablet, dose TBD, twice daily, Cohort 7, 28 days
PF-06882961 dose TBD Cohort 8
PF-06882961
Tablet, dose TBD, twice daily, Cohort 8, 28 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Tablet, 0 mg, twice daily, 28 days
PF-06882961
Tablet, 15 mg twice daily, 28 days
PF-06882961
Tablet, 50 mg twice daily, 28 days
PF-06882961
Tablet, 150 mg twice daily, 28 days
PF-06882961
Tablet, 300 mg twice daily, 28 days
PF-06882961
Tablet, dose TBD, twice daily, Cohort 5, 28 days
PF-06882961
Tablet, dose TBD, twice daily, Cohort 6, 28 days
PF-06882961
Tablet, dose TBD, twice daily, Cohort 7, 28 days
PF-06882961
Tablet, dose TBD, twice daily, Cohort 8, 28 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HbA1c value between 7.0 and 10.5%
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Qps-Mra, Llc
South Miami, Florida, United States
Qps-Mra,Llc
South Miami, Florida, United States
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C3421002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.