Diabetes Mellitus, Type IIPhase 2NCT02175121

Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus

A Phase 2 study testing PF-06291874 in people with Diabetes Mellitus, Type II, run by Pfizer at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is going to assess the safety and tolerability of PF-06291874 in adults with Type 2 Diabetes Mellitus as monotherapy, to evaluate the significance of overall glycemic control in these subjects. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus, Type II
What is being tested?: PF-06291874
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 172 participants
Where: 19 sitesUnited States
Study dates: Aug 2014to Mar 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male subjects and non-childbearing potential female subjects between the ages of 18 and 70 years old.
Body Mass Index of 18.0 to 45.4 kg/m2; and a total body weight of >50 kg
HbA1c value at the screening visit meeting once of the following criteria:
Currently taking acceptable oral antiglycemic drug therapy within 6.5 to 9.5%
Not currently taking any oral antiglycemic drug therapy within 7 to 10.5%
Fasting plasma glucose concentrations<270mg/dL at the screening and run-in visit, confirmed by a single repeat, if deemed necessary.
Subjects must be willing and able to perform self-tests of blood glucose at least 4 times per day, and maintain a diary for the duration of participation in the study; and therefore, subjects must be literate.

Who cannot join

History of Type 1 diabetes mellitus or secondary forms of diabetes
One or more self-reported hypoglycemic episodes of sever intensity within 3 months of screening; or 2 or more self-reported hypoglycemic episodes of severe intensity within the previous 6 months.
History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II-IV heart failure, or transient ischemic attach within 6 months of screening.
History or evidence of diabetic complications with significant end organ damage, such as
Proliferative retinopathy and/or macular edema;
Diabetic neuropathy complicated by neuropathic ulcers;
Screening seated systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg after at least a 5 minute seated rest. If the blood pressure exceeds this limit, the blood pressure may be repeated 2 more times following approximately 2 minutes of rest between measurements and the median of the 3 values should be used to determine subject eligibility;
Male subjects with partners currently pregnant; or male subjects capable of conceiving children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Buffalo Clinical Research Center, LLC
Buffalo, New York, 14202
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911
Community Research
Cincinnati, Ohio, 45255
Avail Clinical Research, LLC
DeLand, Florida, 32720
Clinilabs, Inc.
Eatontown, New Jersey, 07724
High Point Clinical Trials Center, LLC
High Point, North Carolina, 27265
Louisville Metabolic and Atherosclerosis Research Center
Louisville, Kentucky, 40213
PRA International
Marlton, New Jersey, 08053
SeaView Research, Inc.
Miami, Florida, 33125
SeaView Research, Inc.
Miami, Florida, 33126
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Compass Research, LLC
Orlando, Florida, 32806
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Miami Research Associates, Inc.
South Miami, Florida, 33143
MRA Clinical Research, LLC
South Miami, Florida, 33143
MRA Clinical Research
South Miami, Florida, 33143
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of Pf-06291874 Given As Monotherapy To Adults With Type 2 Diabetes Mellitus

Conditions: Diabetes Mellitus, Type II
Being tested: Placebo, PF-06291874
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Tablet, once daily for 28 days
PF-06291874Drug
Tablet, 15 mg, once daily for 28 days
PF-06291874Drug
Tablet, 35 mg, once daily for 28 days
PF-06291874Drug
Tablet, 75 mg, once daily for 28 days
PF-06291874Drug
Tablet, 150 mg, once daily for 28 days

Study groups in NCT02175121
Study group	Role	What they receive
Treatment A- Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Treatment B- PF-06291874	Experimental	Not described Receives: Drug: PF-06291874
Treatment C- PF-06291874	Experimental	Not described Receives: Drug: PF-06291874
Treatment D- PF-06291874	Experimental	Not described Receives: Drug: PF-06291874
Treatment E- PF-06291874	Experimental	Not described Receives: Drug: PF-06291874

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), or Serious Adverse Events (SAEs), or Hypoglycemic Adverse Events (HAE) or Withdrawals Due to Adverse Events (AEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. An HAE was identified by characteristic symptoms or blood glucose levels. TEAEs are events between first dose of study drug and up to 10-14 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
Measured: Baseline up to 10-14 days after last dose of study drug, up to 42 days
Number of Participants With Laboratory Test Abnormalities
The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests.
Measured: Baseline up to 10-14 days after last dose of study drug, up to 42 days
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern
Vital Signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), pulse rate <40 or greater than (>) 120 beats per minute (bpm).
Measured: Baseline up to 10-14 days after last dose of study drug, up to 42 days
Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern
ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): >=140 msec; >=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=300 milliseconds (msec); >=25 percent (%) increase when baseline >200 msec; or increase >=50% when baseline less than or equal to (<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >=500 msec; increase from baseline >=30 - <60, >=60 msec.
Measured: Baseline up to 10-14 days after last dose of study drug, up to 42 days

Secondary outcomes (21)

Change From Baseline in Mean Daily Glucose
The mean daily glucose was determined from the area under the concentration (AUC) of the glucose concentrations measured at nominal times 0, 0.5, 1, 1.5, 2, 4, 6, 10, 12, 15 and 24 hours post dose. Mean daily glucose change from baseline (defined as Day 0) on Day 28.
Measured: Baseline and Day 28
Change From Baseline in Fasting Plasma Glucose
Fasting plasma glucose response change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.
Measured: Baseline, Day 14 and the mean of Days 28 and 29
Percent Change From Baseline in Triglycerides
Triglycerides percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.
Measured: Baseline, Day 14 and the mean of Days 28 and 29
Percent Change From Baseline in Total Cholesterol
Total cholesterol percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.
Measured: Baseline, Day 14 and the mean of Days 28 and 29
Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)
LDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.
Measured: Baseline, Day 14 and the mean of Days 28 and 29
Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)
HDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.
Measured: Baseline, Day 14 and the mean of Days 28 and 29
Percent Change From Baseline in Non-HDL-C
Non-HDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.
Measured: Baseline, Day 14 and the mean of Days 28 and 29
Percent Change From Baseline in Oxidized LDL
Oxidized LDL percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).
Measured: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in Large LDL Particles
Large LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).
Measured: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in Medium Small LDL Particles
Medium small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).
Measured: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in Small LDL Particles
Small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).
Measured: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in Very Small LDL Particles
Very small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).
Measured: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in Total LDL Particles
Total LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).
Measured: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in LDL Size
The LDL size percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).
Measured: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in Apolipoprotein B100
The Apolipoprotein B100 was calculated as the difference between total Apolipoprotein B and Apolipoprotein B48 and analyzed the percent change from baseline (defined as mean of Day 0 and Day 1) on Day 28 (mean of Days 28 and 29).
Measured: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in Lipoprotein A
The Lipoprotein A percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (mean of Days 28 and 29).
Measured: Baseline and the mean of Days 28 and 29
Maximum Plasma Concentration (Cmax)
Maximum PF-06291874 plasma concentration.
Measured: Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)
Time to Reach Cmax (Tmax)
Time to maximum PF-06291874 plasma concentration.
Measured: Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)
Area Under the Concentration-Time Profile From Zero to Time Tau (AUCtau) (Where Tau=24 Hours)
Area under the PF-06291874 plasma concentration-time profile from time zero to time tau, the dosing interval, where tau=24 hours.
Measured: Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)
Minimum Plasma Concentration (Cmin)
Minimum PF-06291874 plasma concentration.
Measured: Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)
Apparent Clearance (CL/F)
Apparent oral clearance of PF-06291874.
Measured: Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Mar 2015

First posted26 Jun 2014 (estimated)
Study startAug 2014
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02175121
Sponsor's protocol ID: B4801011
Status last verified: May 2016
First submitted: 24 Jun 2014
Last updated: 15 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of Pf-06291874 Given As Monotherapy To Adults With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02175121
Acronym / sponsor ID: B4801011
Conditions: Diabetes Mellitus, Type II
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 172 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 26 Jun 2014 (estimated)
Results: Posted 15 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Treatment A- Placebo	Placebo comparator	Drug: Placebo
Treatment B- PF-06291874	Experimental	Drug: PF-06291874
Treatment C- PF-06291874	Experimental	Drug: PF-06291874
Treatment D- PF-06291874	Experimental	Drug: PF-06291874
Treatment E- PF-06291874	Experimental	Drug: PF-06291874

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male subjects and non-childbearing potential female subjects between the ages of 18 and 70 years old.
Body Mass Index of 18.0 to 45.4 kg/m2; and a total body weight of >50 kg
HbA1c value at the screening visit meeting once of the following criteria:
Fasting plasma glucose concentrations<270mg/dL at the screening and run-in visit, confirmed by a single repeat, if deemed necessary.
Subjects must be willing and able to perform self-tests of blood glucose at least 4 times per day, and maintain a diary for the duration of participation in the study; and therefore, subjects must be literate.

Key exclusion criteria (8 listed)

History of Type 1 diabetes mellitus or secondary forms of diabetes
One or more self-reported hypoglycemic episodes of sever intensity within 3 months of screening; or 2 or more self-reported hypoglycemic episodes of severe intensity within the previous 6 months.
History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II-IV heart failure, or transient ischemic attach within 6 months of screening.
History or evidence of diabetic complications with significant end organ damage, such as
Screening seated systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg after at least a 5 minute seated rest. If the blood pressure exceeds this limit, the blood pressure may be repeated 2 more times following approximately 2 minutes of rest between measurements and the median of the 3 values should be used to determine subject eligibility;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboTablet, once daily for 28 days	Drug	Treatment A- Placebo
PF-06291874Tablet, 15 mg, once daily for 28 days	Drug	Treatment B- PF-06291874
PF-06291874Tablet, 35 mg, once daily for 28 days	Drug	Treatment C- PF-06291874
PF-06291874Tablet, 75 mg, once daily for 28 days	Drug	Treatment D- PF-06291874
PF-06291874Tablet, 150 mg, once daily for 28 days	Drug	Treatment E- PF-06291874

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), or Serious Adverse Events (SAEs), or Hypoglycemic Adverse Events (HAE) or Withdrawals Due to Adverse Events (AEs)
Time frame: Baseline up to 10-14 days after last dose of study drug, up to 42 days
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. An HAE was identified by characteristic symptoms or blood glucose levels. TEAEs are events between first dose of study drug and up to 10-14 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
Number of Participants With Laboratory Test Abnormalities
Time frame: Baseline up to 10-14 days after last dose of study drug, up to 42 days
The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests.
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern
Time frame: Baseline up to 10-14 days after last dose of study drug, up to 42 days
Vital Signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), pulse rate <40 or greater than (>) 120 beats per minute (bpm).
Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern
Time frame: Baseline up to 10-14 days after last dose of study drug, up to 42 days
ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): >=140 msec; >=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=300 milliseconds (msec); >=25 percent (%) increase when baseline >200 msec; or increase >=50% when baseline less than or equal to (<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >=500 msec; increase from baseline >=30 - <60, >=60 msec.

21 secondary outcomes

Change From Baseline in Mean Daily Glucose
Time frame: Baseline and Day 28
Change From Baseline in Fasting Plasma Glucose
Time frame: Baseline, Day 14 and the mean of Days 28 and 29
Percent Change From Baseline in Triglycerides
Time frame: Baseline, Day 14 and the mean of Days 28 and 29
Percent Change From Baseline in Total Cholesterol
Time frame: Baseline, Day 14 and the mean of Days 28 and 29
Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)
Time frame: Baseline, Day 14 and the mean of Days 28 and 29
Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)
Time frame: Baseline, Day 14 and the mean of Days 28 and 29
Percent Change From Baseline in Non-HDL-C
Time frame: Baseline, Day 14 and the mean of Days 28 and 29
Percent Change From Baseline in Oxidized LDL
Time frame: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in Large LDL Particles
Time frame: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in Medium Small LDL Particles
Time frame: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in Small LDL Particles
Time frame: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in Very Small LDL Particles
Time frame: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in Total LDL Particles
Time frame: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in LDL Size
Time frame: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in Apolipoprotein B100
Time frame: Baseline and the mean of Days 28 and 29
Percent Change From Baseline in Lipoprotein A
Time frame: Baseline and the mean of Days 28 and 29
Maximum Plasma Concentration (Cmax)
Time frame: Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)
Time to Reach Cmax (Tmax)
Time frame: Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)
Area Under the Concentration-Time Profile From Zero to Time Tau (AUCtau) (Where Tau=24 Hours)
Time frame: Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)
Minimum Plasma Concentration (Cmin)
Time frame: Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)
Apparent Clearance (CL/F)
Time frame: Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)

Results and safety

Results posted to the registry on 15 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	34	33
PF-06291874 15 mg	35	34
PF-06291874 35 mg	34	32
PF-06291874 75 mg	35	34
PF-06291874 150 mg	34	33

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), or Serious Adverse Events (SAEs), or Hypoglycemic Adverse Events (HAE) or Withdrawals Due to Adverse Events (AEs)

Time frame: Baseline up to 10-14 days after last dose of study drug, up to 42 days. Number. Unit: participants

Measure	Placebo n = 34	PF-06291874 15 mg n = 35	PF-06291874 35 mg n = 34	PF-06291874 75 mg n = 35	PF-06291874 150 mg n = 34
Number of Participants With AEs	11	7	10	11	12
Number of Participants with SAEs	0	0	0	1	0
Number of Participants with Protocol-Defined HAEs	0	0	0	1	0
Number of Participants discontinued from study	1	1	2	1	1

Population analysed: The safety analysis set was defined as all participants who received at least 1 dose of study drug.

Primary outcome: Number of Participants With Laboratory Test Abnormalities

Time frame: Baseline up to 10-14 days after last dose of study drug, up to 42 days. Number. Unit: participants

Measure	Placebo n = 34	PF-06291874 15 mg n = 35	PF-06291874 35 mg n = 34	PF-06291874 75 mg n = 35	PF-06291874 150 mg n = 34
Value	31	31	24	32	30

Population analysed: The safety analysis set was defined as all participants who received at least 1 dose of study drug.

Primary outcome: Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern

Time frame: Baseline up to 10-14 days after last dose of study drug, up to 42 days. Number. Unit: participants

Measure	Placebo n = 34	PF-06291874 15 mg n = 35	PF-06291874 35 mg n = 34	PF-06291874 75 mg n = 35	PF-06291874 150 mg n = 34
Supine SBP <90 mm Hg	3	0	0	0	0
Supine DBP <50 mm Hg	1	0	0	0	0
Increase: supine SBP >=30 mm Hg	3	3	3	1	6
Increase: supine DBP >=20 mm Hg	1	0	2	1	0
Decrease: supine SBP >= 30 mm Hg	1	0	0	0	0
Decrease: supine DBP >=20 mm Hg	3	0	0	0	0
Pulse rate <40 bpm	0	0	0	0	0
Pulse rate >120 bpm	0	0	0	0	0

Population analysed: The safety analysis set was defined as all participants who received at least 1 dose of study drug.

Primary outcome: Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern

Time frame: Baseline up to 10-14 days after last dose of study drug, up to 42 days. Number. Unit: participants

Measure	Placebo n = 34	PF-06291874 15 mg n = 35	PF-06291874 35 mg n = 34	PF-06291874 75 mg n = 35	PF-06291874 150 mg n = 34
PR interval >=300 msec	0	0	0	0	0
QRS interval >=140 msec	0	0	0	0	0
QTcF interval 450-480 msec	2	4	4	2	3
QTcF interval 480-500 msec	0	0	1	0	1
QTcF interval >=500 msec	0	0	0	0	0
PR interval increase >=25%/50%	0	1	0	0	0
QRS interval increase >=50%	0	0	0	0	0
QTcF interval increase 30-60 msec	1	5	4	4	5

Population analysed: The safety analysis set was defined as all participants who received at least 1 dose of study drug.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline to 10-14 days after the last dose of the study drug, up to 42 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 34 (0%)	4 of 34 (11.8%)	Not reported
PF-06291874 15 mg	0 of 35 (0%)	4 of 35 (11.4%)	Not reported
PF-06291874 35 mg	0 of 34 (0%)	8 of 34 (23.5%)	Not reported
PF-06291874 75 mg	1 of 35 (2.9%)	6 of 35 (17.1%)	Not reported
PF-06291874 150 mg	0 of 34 (0%)	6 of 34 (17.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
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Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-06291874 in people with Diabetes Mellitus, Type II, run by Pfizer at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), or Serious Adverse Events (SAEs), or Hypoglycemic Adverse Events (HAE) or Withdrawals Due to Adverse Events (AEs) (time frame: Baseline up to 10-14 days after last dose of study drug, up to 42 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02175121.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2016.