Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes

December 6, 2016 updated by: Pfizer

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

B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
345

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Balatonfured, Hungary, 8230
        • DRC Kft.
      • Bekescsaba, Hungary, 5600
        • Dr. Rethy Pal Korhaz-Rendelointezet
      • Budapest, Hungary, 1036
        • Qualiclinic Kft.
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
      • Debrecen, Hungary, 4043
        • Kenezy Korhaz Rendelointezet Egeszsegugyi Nonprofit Kft.
      • Gyor, Hungary, 9023
        • Petz Aladar Megyei Oktato Korhaz
      • Polgar, Hungary, 4090
        • Polgar es Tersege Egeszsegugyi Kozpont Nonprofit Zrt.
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
      • Zalaegerszeg, Hungary, 8900
        • Zala Megyei Kórház
  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 007
        • Bhatia Hospital
      • Mumbai, Maharashtra, India, 400 012
        • Seth G S Medical College & KEM Hospital, Dept of Endocrinology,
      • Pune, Maharashtra, India, 411001
        • Jehangir Clinical Development Centre Pvt. Ltd.
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
        • S.R. Kalla Memorial Gastro and General Hospital
  • Philippines
      • Cebu City, Philippines, 6000
        • Vicente Sotto Memorial Medical Center
      • Marikina City, Philippines, 1810
        • Institute for Studies on Diabetes Foundation Inc.
      • Pasig City, Philippines, 1605
        • The Medical City
  • Romania
      • Bucuresti, Romania, 011234
        • Institutul National de Diabet, Nutritie si Boli Metabolice Prof. Dr. N. Paulescu
      • Bucuresti, Romania, 020475
        • Institutul National de Diabet, Nutritie si Boli Metabolice Prof. Dr. N. Paulescu
    • Jud. Cluj
      • Cluj-Napoca, Jud. Cluj, Romania, 400006
        • Spitalul Clinic Judetean de Urgenta Cluj-Napoca
  • Slovakia
      • Bratislava, Slovakia, 831 01
        • Metabolicke centrum MUDr. Katariny Raslovej, s.r.o.
      • Bratislava, Slovakia, 851 01
        • Medispektrum Plus, s.r.o.
      • Lucenec, Slovakia, 984 01
        • IN-DIA, s.r.o.
      • Nitra, Slovakia, 949 01
        • MUDr. Zuzana Ochodnicka, Interna diabetologicka ambulancia, s.r.o.
      • Nove Mesto nad Vahom, Slovakia, 915 01
        • NOEMIS, s.r.o.
      • Presov, Slovakia, 080 01
        • DIABETOL, s.r.o.
      • Trebisov, Slovakia, 075 01
        • Areteus, s.r.o.
      • Trencin, Slovakia, 911 01
        • Diabetes centrum, s.r.o.
  • South Africa
      • Durban, South Africa, 4091
        • Randles Road Medical Centre
      • Moloto, South Africa, 1022
        • AA Mahomed Medical Centre
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Bloemfontein Medi-Clinic
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1829
        • Dr DR Lakha's Practice
      • Midrand, Gauteng, South Africa, 1685
        • Midrand Medical Centre
      • Pretoria, Gauteng, South Africa, 0083
        • Medi-Clinic Heart Hospital
      • Waverley, Gauteng, South Africa, 2090
        • Dr Bhana
    • Northern Cape
      • Kimberley, Northern Cape, South Africa, 8301
        • Dr JH Mynhardt
  • Taiwan
      • Changhua City, Taiwan, 500
        • Changhua Christian Hospital
      • New Taipei City, Taiwan, 220
        • Far Eastern Memorial Hospital, Division of Endocrinology and Metabolism
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital, Division of Metabolism and Endocrinology
      • Tainan, Taiwan, 710
        • Chi Mei Medical Center
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials
      • Los Angeles, California, United States, 90057
        • National Research Institute
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
    • Florida
      • Belleview, Florida, United States, 34420
        • The Family Doctors of Belleview
      • Miami, Florida, United States, 33135
        • Swiss Medical Research
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
    • Georgia
      • Conyers, Georgia, United States, 30094
        • Rockdale Medical Research Associates
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
    • Kentucky
      • Mount Sterling, Kentucky, United States, 40353
        • Central Kentucky Research Associates, Inc.
      • Mount Sterling, Kentucky, United States, 40353
        • Mount Sterling Clinic
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • The Office of Dr. Matthew S. Barton, MD
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • TKL Research, Inc.
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc.
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Lillestol Research, LLC
    • Ohio
      • Kettering, Ohio, United States, 45429
        • PriMED Clinical Research
      • Kettering, Ohio, United States, 45429
        • PriMed Physicians
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Medical Research South, LLC
      • Charleston, South Carolina, United States, 29407
        • Newton Family Medicine
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Center for Clinical Research
      • Houston, Texas, United States, 77081
        • Texas Center for Drug Development, Inc.
      • Plano, Texas, United States, 75024
        • Plano Primary Care Clinic
      • Sugar Land, Texas, United States, 77479
        • Pioneer Research Solutions, Inc.
      • Tomball, Texas, United States, 77375
        • Martin Diagnostic Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female

Exclusion Criteria:

  • patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory test results at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
double-dummy placebo tablets administered once-daily for 84-days
Active Comparator: Sitagliptin
Drug: Sitagliptin - 100mg
Sitagliptin 100mg administered as tablets once-daily for 84-days
Experimental: PF-04937319 - Dose 1
Drug: PF-04937319 - 3mg
PF-04937319 3mg administered as tablets once-daily for 84-days
Experimental: PF-04937319 - Dose 2
Drug: PF-04937319 - 20mg
PF-04937319 20mg administered as tablets once-daily for 84-days
Experimental: PF-04937319 - Dose 3
Drug: PF-04937319 - 50mg
PF-04937319 50mg administered as tablets once-daily for 84-days
Experimental: PF-04937319 - Dose 4
Drug: PF-04937319 - 100mg
PF-04937319 100mg administered as tablets once-daily for 84-days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12
Time Frame: Baseline (Day 1), 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Increase/Decrease From Baseline Vital Signs Data
Time Frame: Baseline (Day 1) up to Week 14
Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator's discretion.
Baseline (Day 1) up to Week 14
Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8
Time Frame: Baseline(Day 1), Week 2, 4, 8
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 <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 2, 4, 8
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14
Time Frame: Baseline (Day 1), Week 1, 2, 4, 8, 12, 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
Time Frame: 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 <6.5 percent by the study-specific central laboratory used and data are presented in categories of <6.5 percent and <7 percent.
Week 12
Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data
Time Frame: Baseline (Day 1) up to Week 14
Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline>200 then percent change of >25% counts; if baseline <=200 then percent change of >50% counts]; QRS complex (percent change of >=50%); QT Fridericia's correction (QTcF) interval (change of >=30 to <60 millisecond [msec], and change of >=60 msec).
Baseline (Day 1) up to Week 14
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time Frame: Baseline (Day 1) up to 14 days after last dose (up to 101 days)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Baseline (Day 1) up to 14 days after last dose (up to 101 days)
Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode
Time Frame: Baseline (Day 1) up to Week 14
A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE is defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.
Baseline (Day 1) up to Week 14
Number of Hypoglycemic Events (HAE) Episodes Per Participant
Time Frame: Baseline (Day 1) up to Week 14
A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Median number of events per participant was reported
Baseline (Day 1) up to Week 14
Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14
Time Frame: Baseline (Day 1), Week 2, 4, 8 , 12 , 14
Baseline (Day 1), Week 2, 4, 8 , 12 , 14
Number of Participants With Abnormal Laboratory Values
Time Frame: Baseline (Day 1) up to Week 14
Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal[LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test).
Baseline (Day 1) up to Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B1621007
  • 2011-004002-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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