Anaheim, California 92801

  • Type 2 Diabetes Mellitus


The purpose of this study is to determine whether PF-06291874 is effective in the treatment T2DM

Study summary:

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.


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;

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

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

Overall Status:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:

70 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:


Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification: S

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Pfizer Call Center
Study Director

Study Dates

Start Date:October 2015
Completion Date:August 2016
Completion Type:Actual
Primary Completion Date:August 2016
Primary Completion Type:Actual
Verification Date:September 2016
Last Changed Date:September 15, 2016
First Received Date:September 17, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change from baseline in Hemoglobin A1c (HbA1c)
Time Frame:Baseline, 12weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in HbA1c (%)
Time Frame:at Baseline and Weeks 2, 4, & 8
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in fasting plasma glucose
Time Frame:at Baseline and weeks 2, 4, 8, and 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Proportion of subjects achieving HbA1C <7%
Time Frame:at Week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in lipid parameters
Time Frame:at Baseline, Weeks 2, 4, 8, and 12
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Change from baseline in body weight
Time Frame:at Baseline, Weeks 2, 4, 8, and 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Proportion of subjects achieving HbA1C <6.5%
Time Frame:at Week 12
Safety Issues:False

Study Interventions

Intervention Type:Drug
Description:study drug to be given as an oral tablet at 30, 60 or 100 mg
Arm Name:PF-06291874, 30 mg
Intervention Type:Drug
Description:oral tablet
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Study Arm Type:Experimental
Arm Name:PF-06291874, 30 mg
Study Arm Type:Experimental
Arm Name:PF-06291874, 60 mg
Study Arm Type:Experimental
Arm Name:PF-06291874, 100 mg

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

This study is not currently recruiting Study Participants. The form below is not enabled.