Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes
A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety And Efficacy Of Pf-04937319 And Sitagliptin On Glycemic Control In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
2 other identifiers
interventional
345
8 countries
63
Brief Summary
B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes-mellitus
Started Nov 2011
63 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
September 15, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
January 31, 2017
CompletedJanuary 31, 2017
December 1, 2016
1.2 years
September 15, 2011
December 6, 2016
December 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12
HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than (\<) 6.5 percent (%) by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.
Baseline (Day 1), Week 12
Secondary Outcomes (10)
Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8
Baseline(Day 1), Week 2, 4, 8
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14
Baseline (Day 1), Week 1, 2, 4, 8, 12, 14
Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12
Week 12
Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data
Baseline (Day 1) up to Week 14
Number of Participants With Increase/Decrease From Baseline Vital Signs Data
Baseline (Day 1) up to Week 14
- +5 more secondary outcomes
Study Arms (6)
Placebo
PLACEBO COMPARATORPF-04937319 - Dose 1
EXPERIMENTALPF-04937319 - Dose 2
EXPERIMENTALPF-04937319 - Dose 3
EXPERIMENTALPF-04937319 - Dose 4
EXPERIMENTALSitagliptin
ACTIVE COMPARATORInterventions
PF-04937319 3mg administered as tablets once-daily for 84-days
PF-04937319 20mg administered as tablets once-daily for 84-days
PF-04937319 50mg administered as tablets once-daily for 84-days
PF-04937319 100mg administered as tablets once-daily for 84-days
Eligibility Criteria
You may qualify if:
- patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female
You may not qualify if:
- patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory test results at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (63)
Anaheim Clinical Trials
Anaheim, California, 92801, United States
National Research Institute
Los Angeles, California, 90057, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
The Family Doctors of Belleview
Belleview, Florida, 34420, United States
Swiss Medical Research
Miami, Florida, 33135, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Rockdale Medical Research Associates
Conyers, Georgia, 30094, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Central Kentucky Research Associates, Inc.
Mount Sterling, Kentucky, 40353, United States
Mount Sterling Clinic
Mount Sterling, Kentucky, 40353, United States
The Office of Dr. Matthew S. Barton, MD
Las Vegas, Nevada, 89144, United States
TKL Research, Inc.
Paramus, New Jersey, 07652, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Lillestol Research, LLC
Fargo, North Dakota, 58103, United States
PriMed Clinical Research
Kettering, Ohio, 45429, United States
PriMed Physicians
Kettering, Ohio, 45429, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Medical Research South, LLC
Charleston, South Carolina, 29407, United States
Newton Family Medicine
Charleston, South Carolina, 29407, United States
Austin Center for Clinical Research
Austin, Texas, 78756, United States
Texas Center for Drug Development, Inc.
Houston, Texas, 77081, United States
Plano Primary Care Clinic
Plano, Texas, 75024, United States
Pioneer Research Solutions, Inc.
Sugar Land, Texas, 77479, United States
Martin Diagnostic Clinic
Tomball, Texas, 77375, United States
DRC Kft.
Balatonfüred, 8230, Hungary
Dr. Rethy Pal Korhaz-Rendelointezet
Békéscsaba, 5600, Hungary
Qualiclinic Kft.
Budapest, 1036, Hungary
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen, 4032, Hungary
Kenezy Korhaz Rendelointezet Egeszsegugyi Nonprofit Kft.
Debrecen, 4043, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9023, Hungary
Polgar es Tersege Egeszsegugyi Kozpont Nonprofit Zrt.
Polgár, 4090, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6720, Hungary
Zala Megyei Korhaz
Zalaegerszeg, 8900, Hungary
Bhatia Hospital
Mumbai, Maharashtra, 400 007, India
Seth G S Medical College & KEM Hospital, Dept of Endocrinology,
Mumbai, Maharashtra, 400 012, India
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, Maharashtra, 411001, India
S.R. Kalla Memorial Gastro and General Hospital
Jaipur, Rajasthan, 302001, India
Vicente Sotto Memorial Medical Center
Cebu City, 6000, Philippines
Institute for Studies on Diabetes Foundation Inc.
Marikina City, 1810, Philippines
The Medical City
Pasig, 1605, Philippines
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, Jud. Cluj, 400006, Romania
Institutul National de Diabet, Nutritie si Boli Metabolice Prof. Dr. N. Paulescu
Bucharest, 011234, Romania
Institutul National de Diabet, Nutritie si Boli Metabolice Prof. Dr. N. Paulescu
Bucharest, 020475, Romania
Metabolicke centrum MUDr. Katariny Raslovej, s.r.o.
Bratislava, 831 01, Slovakia
Medispektrum Plus, s.r.o.
Bratislava, 851 01, Slovakia
IN-DIA, s.r.o.
Lučenec, 984 01, Slovakia
MUDr. Zuzana Ochodnicka, Interna diabetologicka ambulancia, s.r.o.
Nitra, 949 01, Slovakia
NOEMIS, s.r.o.
Nové Mesto nad Váhom, 915 01, Slovakia
DIABETOL, s.r.o.
Prešov, 080 01, Slovakia
Areteus, s.r.o.
Trebišov, 075 01, Slovakia
Diabetes centrum, s.r.o.
Trenčín, 911 01, Slovakia
Bloemfontein Medi-Clinic
Bloemfontein, Free State, 9301, South Africa
Dr DR Lakha's Practice
Johannesburg, Gauteng, 1829, South Africa
Midrand Medical Centre
Midrand, Gauteng, 1685, South Africa
Medi-Clinic Heart Hospital
Pretoria, Gauteng, 0083, South Africa
Dr Bhana
Waverley, Gauteng, 2090, South Africa
Dr JH Mynhardt
Kimberley, Northern Cape, 8301, South Africa
Randles Road Medical Centre
Durban, 4091, South Africa
AA Mahomed Medical Centre
Moloto South, 1022, South Africa
Changhua Christian Hospital
Changhua, 500, Taiwan
Far Eastern Memorial Hospital, Division of Endocrinology and Metabolism
New Taipei City, 220, Taiwan
Taichung Veterans General Hospital, Division of Metabolism and Endocrinology
Taichung, 40705, Taiwan
Chi Mei Medical Center
Tainan, 710, Taiwan
Related Publications (1)
Amin NB, Aggarwal N, Pall D, Paragh G, Denney WS, Le V, Riggs M, Calle RA. Two dose-ranging studies with PF-04937319, a systemic partial activator of glucokinase, as add-on therapy to metformin in adults with type 2 diabetes. Diabetes Obes Metab. 2015 Aug;17(8):751-9. doi: 10.1111/dom.12474. Epub 2015 May 11.
PMID: 25885172DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2011
First Posted
November 21, 2011
Study Start
November 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
January 31, 2017
Results First Posted
January 31, 2017
Record last verified: 2016-12