A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin

NCT02554877

Last updated date
Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Males or non-childbearing potential females between the ages of 18 (or the minimum country specific age of consent if >18) and 70 years, inclusive, at the screening visit (V1) with the diagnosis of T2DM;Female subjects who are not of childbearing potential

2. Subjects who have been on a stable dose of metformin either alone or in combination with one additional acceptable OAD

3. HbA1c at the Screen Visit (V1), as assessed by study specific central laboratory, is 7-11% if on metformin monotherapy; is 6.5-9.5% if on dual combination therapy (metformin plus 1)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;


2. Fasting plasma glucose levels >270 mg/dL (15.0 mmol/L) at the screening and run in
visit, (as assessed by study specific central laboratory) confirmed by a single
repeat, if deemed necessary


3. History of myocardial infarction, unstable angina, arterial revascularization, stroke,
New York Heart Association Functional Class III IV heart failure, or transient
ischemic attack within 6 months of screening;


4. Any medical condition possibly affecting study drug absorption (eg, gastrectomy or any
area of intestinal resection, active inflammatory bowel disease or pancreatic
insufficiency


5. Subjects with a creatinine clearance <60 mL/min as determined by the Cockcroft Gault
equation (listed below) using serum creatinine measured at screening, confirmed via a
single repeat, if deemed necessary


6. Subject with a positive result for hepatitis B surface antigen (HBsAg), hepatitis B
core antibodies (HBc Ab) or hepatitis C virus (HCV) antibodies


7. Screening seated systolic blood pressure >160 mm Hg and/or diastolic blood pressure
>105 mm Hg after at least a 5 minute rest. Blood pressure determined as the mean of
triplicate measurements collected with approximately 2 minutes of rest between
measurements


8. Screening supine 12 lead ECG demonstrating a corrected QT (QTc) >470 msec; or a QRS
interval >120 msec. If QTc exceeds 470 msec or QRS exceeds 120 msec, the ECG may be
repeated 2 more times with an interval of 2-4 minutes between each measurement and the
mean of the 3 values used to determine the subject's eligibility


9. Subjects with an arm circumference >52 cm measured at the midpoint of the length of
the upper arm;


10. History (within the last 6 months) of regular alcohol consumption exceeding 14 drinks
per week for men and 7 drinks a week for women. (1 drink = 5 ounces of wine (150 mL)
or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor);


11. Treatment with thiazolidinediones (TZDs), or subcutaneously administered anti diabetic
agents (eg, insulin, exenatide, liraglutide, pramlintide) within 6 weeks prior to V1;


12. Subjects with a known hypersensitivity or intolerance to a glucagon receptor
antagonist, or known prior participation in a trial involving PF 06291874;

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Advanced Information
Descriptive Information
Brief Title  ICMJE A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin
Official Title  ICMJE A 12-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once Daily Pf-06291874 Administration In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Brief Summary The purpose of this study is to determine whether PF-06291874 is effective in the treatment T2DM
Detailed Description This will be a randomized, double blind, stratified, placebo controlled, parallel group study conducted in T2DM subjects receiving background metformin therapy. Subjects will complete screening procedures to determine eligibility, followed by an 8 week metformin stabilization period prior to randomization. In addition, subjects taking other OADs, in combination with metformin, will undergo a washout during this period, in which non metformin OAD medications will be temporarily discontinued for the duration of the trial. Following confirmation of study eligibility criteria at randomization, subjects will be stratified into 2 groups based on the use of concomitant statin therapy. Each stratum will be randomized across treatment groups, such that the number of subjects taking concomitant statin therapy and those not taking statin therapy will be approximately balanced across treatment groups.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: PF-06291874
    study drug to be given as an oral tablet at 30, 60 or 100 mg
  • Drug: Placebo
    oral tablet
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06291874, 30 mg
    Intervention: Drug: PF-06291874
  • Experimental: PF-06291874, 60 mg
    Intervention: Drug: PF-06291874
  • Experimental: PF-06291874, 100 mg
    Intervention: Drug: PF-06291874
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2016)
206
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2015)
200
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males or non-childbearing potential females between the ages of 18 (or the minimum country specific age of consent if >18) and 70 years, inclusive, at the screening visit (V1) with the diagnosis of T2DM;Female subjects who are not of childbearing potential
  2. Subjects who have been on a stable dose of metformin either alone or in combination with one additional acceptable OAD
  3. HbA1c at the Screen Visit (V1), as assessed by study specific central laboratory, is 7-11% if on metformin monotherapy; is 6.5-9.5% if on dual combination therapy (metformin plus 1)

Exclusion Criteria:

  1. Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;
  2. Fasting plasma glucose levels >270 mg/dL (15.0 mmol/L) at the screening and run in visit, (as assessed by study specific central laboratory) confirmed by a single repeat, if deemed necessary
  3. History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class III IV heart failure, or transient ischemic attack within 6 months of screening;
  4. Any medical condition possibly affecting study drug absorption (eg, gastrectomy or any area of intestinal resection, active inflammatory bowel disease or pancreatic insufficiency
  5. Subjects with a creatinine clearance <60 mL/min as determined by the Cockcroft Gault equation (listed below) using serum creatinine measured at screening, confirmed via a single repeat, if deemed necessary
  6. Subject with a positive result for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Ab) or hepatitis C virus (HCV) antibodies
  7. Screening seated systolic blood pressure >160 mm Hg and/or diastolic blood pressure >105 mm Hg after at least a 5 minute rest. Blood pressure determined as the mean of triplicate measurements collected with approximately 2 minutes of rest between measurements
  8. Screening supine 12 lead ECG demonstrating a corrected QT (QTc) >470 msec; or a QRS interval >120 msec. If QTc exceeds 470 msec or QRS exceeds 120 msec, the ECG may be repeated 2 more times with an interval of 2-4 minutes between each measurement and the mean of the 3 values used to determine the subject's eligibility
  9. Subjects with an arm circumference >52 cm measured at the midpoint of the length of the upper arm;
  10. History (within the last 6 months) of regular alcohol consumption exceeding 14 drinks per week for men and 7 drinks a week for women. (1 drink = 5 ounces of wine (150 mL) or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor);
  11. Treatment with thiazolidinediones (TZDs), or subcutaneously administered anti diabetic agents (eg, insulin, exenatide, liraglutide, pramlintide) within 6 weeks prior to V1;
  12. Subjects with a known hypersensitivity or intolerance to a glucagon receptor antagonist, or known prior participation in a trial involving PF 06291874;
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02554877
Other Study ID Numbers  ICMJE B4801010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP