Diabetes Mellitus, Type 2Phase 2NCT01792635

A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus

A Phase 2 study testing PF-05175157 in people with Diabetes Mellitus, Type 2, run by Pfizer at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study is designed to assess the safety, tolerability and pharmacodynamics of 6 weeks of oral doses of PF-05175157 provided as monotherapy in subjects with type 2 diabetes mellitus. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: PF-05175157
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 19 participants
Where: 1 siteUnited States
Study dates: Dec 2012to May 2014
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who have been diagnosed with type 2 diabetes mellitus by a medical professional according to the American Diabetes Association guidelines.
Hemoglobin A1c of ≥7 and ≤10.0% in subjects who are metformin-naive or have not taken metformin for 2 months or Hemoglobin A1c of ≥6.5 and ≤9.5% in subjects who are metformin-naïve and are taking SU or DPP-IVi which is washed off or taking metformin and are willing to discontinue metformin in a 8-week washout period.

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine (other than T2DM and hypothyroidism), gastrointestinal, cardiovascular, pulmonary, hepatic, psychiatric or neurologic disease.
A waist circumference which makes fitting imto the bore of the MR scanner impossible.
Subjects with history of dry eye, known ocular or systemic disease that affect the sclera or cornea.

Trial locations and contacts

1 site in 1 country.

United States1 site

Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911

Other trials in United States

About this study

Official title: A 6-week Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel Group Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral Pf-05175157 As Monotherapy In Subjects With Type 2 Diabetes Mellitus

This study is designed to assess the safety, tolerability and pharmacodynamics of 6 weeks of oral doses of PF-05175157 provided as monotherapy in subjects with type 2 diabetes mellitus.

Conditions: Diabetes Mellitus, Type 2
Being tested: PF-05175157, Placebo
Keywords: Type 2 Diabetes Mellitus, Pharmacodynamics, Safety & Tolerability
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.

PF-05175157Drug
PF-05175157 will be administered at 200 mg twice a day for 43 days.
PlaceboDrug
Placebo tablets matched to PF-05175157 will be administered twice a day for 43 days.

Study groups in NCT01792635
Study group	Role	What they receive
Part A (Pilot Study)	No intervention	Not described
Monotherapy (Part B)	Experimental	Not described Receives: Drug: PF-05175157; Drug: Placebo

What is being measured

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

Glucose Infusion Rates (GIR) in Part A
GIR obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. Assessment of whole body insulin sensitivity was performed during the steady states of the low insulin infusion rate (ie, Step 1) and during the steady state of the high insulin infusion rate (ie, Step 2). These indices were called GIR1 and GIR2, respectively.
Measured: 1 day
Endogenous Gucose Production (EGP) in Part A
EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2). Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. EGP was measured under basal conditions; then during the low dose insulin infusion EGP was partially suppressed (hepatic insulin sensitivity), while during the high dose insulin infusion, EGP was almost completely suppressed and peripheral glucose uptake was maximally stimulated (peripheral insulin sensitivity).
Measured: 1 day
[6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A
[6,6-2H2] PGE was the molar fraction of labeled glucose measured in plasma. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity.
Measured: 1 day
Rate of Appearance of Glucose (Ra) in Part A
Rate of appearance of glucose (Ra) in fasting state and during insulin infusions (Step 1 and Step 2).
Measured: 1 day
Whole-body Glucose Uptake in Part A
Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp
Measured: 1 day
Whole-body Glucose Uptake in Part B in Placebo Group
Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp
Measured: 6 weeks
Whole-body Glucose Uptake in Part B in PF-05175157 200 mg BID Group
Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp
Measured: 6 weeks
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) in Part B
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; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Baseline to follow-up (up to approximately 10 to 14 days after the last study drug administration)
Number of Participants With Laboratory Test Abnormalities in Part B
Number of participants with laboratory test abnormalities without regard to baseline abnormality. The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, and creatine phosphokinase); urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy); others (follicle stimulating hormone [FSH], urine drug screen, lipid profile and very-low-density lipoproteins [VLDL], hemoglobin A1c [HbA1c], C-peptide, thyroid-stimulating hormone [TSH], Hepatitis B and C, human immunodeficiency virus [HIV], triglycerides, urine creatinine).
Measured: Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria in Part B
Criteria for potentially clinical important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of less than (<) 90 millimeters of mercury (mm Hg) or change in sitting SBP of greater or equal to (>=)30 mm Hg, sitting diastolic blood pressure (DBP) of <50 mm Hg or change in sitting DBP of >=20 mm Hg, sitting pulse rate of <40 or greater than (>) 120 beats per minute (bpm).
Measured: Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarisation Criteria in Part B
Criteria for PCI changes in ECG (12-lead) were defined as: 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) and increase of >=25% from baseline when baseline >200 msec or increase of >=50% when baseline less than or equal to (<=) 200 msec; the time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS interval) >=140 msec and increase of >=50% from baseline; the time corresponding to the beginning of depolarization to repolarization of the ventricles (QT), corrected for heart rate (QTc) using the Fridericia formula (QTcF) of 450 to < 480 msec and >=480 msec, or an increase from baseline of 30 to <60 msec or >=60 msec.
Measured: Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)

Secondary outcomes (6)

GIR in Part B in Placebo Group
Glucose Infusion Rate rates obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion.
Measured: 6 weeks
GIR in Part B in PF-05175157 200 mg BID Group
Glucose Infusion Rate rates obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion.
Measured: 6 weeks
EGP in Part B in Placebo Group
EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2)
Measured: 6 weeks
EGP in Part B in PF-05175157 200 mg BID Group
EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2)
Measured: 6 weeks
Ra in Part B in Placebo Group
Ra in fasting state and during insulin infusions (Step 1 and Step 2).
Measured: 6 weeks
Ra in Part B in PF-05175157 200 mg BID Group
Ra in fasting state and during insulin infusions (Step 1 and Step 2).
Measured: 6 weeks

Timeline

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

Dec 2012May 2014

First posted15 Feb 2013 (estimated)
Study startDec 2012
Primary completionMay 2014
Study completionMay 2014

Why it stopped: The study was terminated prematurely on 16 May 2014 due to a safety concern.

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 2Studies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01792635
Sponsor's protocol ID: B1731003
Status last verified: Dec 2016
First submitted: 20 Dec 2012
Last updated: 16 Feb 2017
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 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 6-week Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel Group Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral Pf-05175157 As Monotherapy In Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01792635
Acronym / sponsor ID: B1731003
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes Mellitus, Pharmacodynamics, Safety & Tolerability
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated prematurely on 16 May 2014 due to a safety concern.
Enrolment: 19 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 15 Feb 2013 (estimated)
Results: Posted 16 Feb 2017

Clinical summary

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

This study is designed to assess the safety, tolerability and pharmacodynamics of 6 weeks of oral doses of PF-05175157 provided as monotherapy in subjects with type 2 diabetes mellitus.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Part A (Pilot Study)	No intervention	–
Monotherapy (Part B)	Experimental	Drug: PF-05175157, Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subjects who have been diagnosed with type 2 diabetes mellitus by a medical professional according to the American Diabetes Association guidelines.
Hemoglobin A1c of ≥7 and ≤10.0% in subjects who are metformin-naive or have not taken metformin for 2 months or Hemoglobin A1c of ≥6.5 and ≤9.5% in subjects who are metformin-naïve and are taking SU or DPP-IVi which is washed off or taking metformin and are willing to discontinue metformin in a 8-week washout period.

Key exclusion criteria (3 listed)

Evidence or history of clinically significant hematological, renal, endocrine (other than T2DM and hypothyroidism), gastrointestinal, cardiovascular, pulmonary, hepatic, psychiatric or neurologic disease.
A waist circumference which makes fitting imto the bore of the MR scanner impossible.
Subjects with history of dry eye, known ocular or systemic disease that affect the sclera or cornea.

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
PF-05175157PF-05175157 will be administered at 200 mg twice a day for 43 days.	Drug	Monotherapy (Part B)
PlaceboPlacebo tablets matched to PF-05175157 will be administered twice a day for 43 days.	Drug	Monotherapy (Part B)

Primary outcome

Glucose Infusion Rates (GIR) in Part A
Time frame: 1 day
GIR obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. Assessment of whole body insulin sensitivity was performed during the steady states of the low insulin infusion rate (ie, Step 1) and during the steady state of the high insulin infusion rate (ie, Step 2). These indices were called GIR1 and GIR2, respectively.
Endogenous Gucose Production (EGP) in Part A
Time frame: 1 day
EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2). Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. EGP was measured under basal conditions; then during the low dose insulin infusion EGP was partially suppressed (hepatic insulin sensitivity), while during the high dose insulin infusion, EGP was almost completely suppressed and peripheral glucose uptake was maximally stimulated (peripheral insulin sensitivity).
[6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A
Time frame: 1 day
[6,6-2H2] PGE was the molar fraction of labeled glucose measured in plasma. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity.
Rate of Appearance of Glucose (Ra) in Part A
Time frame: 1 day
Rate of appearance of glucose (Ra) in fasting state and during insulin infusions (Step 1 and Step 2).
Whole-body Glucose Uptake in Part A
Time frame: 1 day
Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp
Whole-body Glucose Uptake in Part B in Placebo Group
Time frame: 6 weeks
Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp
Whole-body Glucose Uptake in Part B in PF-05175157 200 mg BID Group
Time frame: 6 weeks
Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) in Part B
Time frame: Baseline to follow-up (up to approximately 10 to 14 days after the last study drug administration)
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; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants With Laboratory Test Abnormalities in Part B
Time frame: Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)
Number of participants with laboratory test abnormalities without regard to baseline abnormality. The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, and creatine phosphokinase); urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy); others (follicle stimulating hormone [FSH], urine drug screen, lipid profile and very-low-density lipoproteins [VLDL], hemoglobin A1c [HbA1c], C-peptide, thyroid-stimulating hormone [TSH], Hepatitis B and C, human immunodeficiency virus [HIV], triglycerides, urine creatinine).
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria in Part B
Time frame: Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)
Criteria for potentially clinical important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of less than (<) 90 millimeters of mercury (mm Hg) or change in sitting SBP of greater or equal to (>=)30 mm Hg, sitting diastolic blood pressure (DBP) of <50 mm Hg or change in sitting DBP of >=20 mm Hg, sitting pulse rate of <40 or greater than (>) 120 beats per minute (bpm).
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarisation Criteria in Part B
Time frame: Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)
Criteria for PCI changes in ECG (12-lead) were defined as: 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) and increase of >=25% from baseline when baseline >200 msec or increase of >=50% when baseline less than or equal to (<=) 200 msec; the time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS interval) >=140 msec and increase of >=50% from baseline; the time corresponding to the beginning of depolarization to repolarization of the ventricles (QT), corrected for heart rate (QTc) using the Fridericia formula (QTcF) of 450 to < 480 msec and >=480 msec, or an increase from baseline of 30 to <60 msec or >=60 msec.

6 secondary outcomes

GIR in Part B in Placebo Group
Time frame: 6 weeks
GIR in Part B in PF-05175157 200 mg BID Group
Time frame: 6 weeks
EGP in Part B in Placebo Group
Time frame: 6 weeks
EGP in Part B in PF-05175157 200 mg BID Group
Time frame: 6 weeks
Ra in Part B in Placebo Group
Time frame: 6 weeks
Ra in Part B in PF-05175157 200 mg BID Group
Time frame: 6 weeks

Results and safety

Results posted to the registry on 16 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants in Part A	6	6
Placebo - Part B	0	0
PF-05175157 200 mg Twice a Day - Part B	0	0

Primary outcome: Glucose Infusion Rates (GIR) in Part A

Time frame: 1 day. Mean (90% Confidence Interval). Unit: mg/min

Measure	All Participants in Part A n = 6
Clamp 1 GIR1	191 (153 to 229)
Clamp 1 GIR2	780 (580 to 980)
Clamp 2 GIR1	152 (132 to 172)

Population analysed: All participants randomized and who had at least one euglycemic hyperinsulinemic clamp

Primary outcome: Endogenous Gucose Production (EGP) in Part A

Time frame: 1 day. Median (Full Range). Unit: mg/kilogram (kg) body weight (BW)/min

Measure	All Participants in Part A n = 6
Clamp 1 EGP0	1.79 (1.48 to 1.99)
Clamp 1 EGP1	0.85 (0.51 to 0.98)
Clamp 1 EGP2	0.07 (-0.02 to 0.36)
Clamp 2 EGP0	1.68 (1.59 to 1.89)
Clamp 2 EGP1	0.81 (0.71 to 0.98)

Population analysed: All participants randomized and who had at least one euglycemic hyperinsulinemic clamp

Primary outcome: [6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A

Time frame: 1 day. Mean (90% Confidence Interval). Unit: percentage enrichment of plasma glucose

Measure	All Participants in Part A n = 6
Clamp 1	2.96 (2.94 to 2.98)
Clamp 2	2.97 (2.88 to 3.06)

Population analysed: All participants randomized and who had at least one euglycemic hyperinsulinemic clamp

Primary outcome: Rate of Appearance of Glucose (Ra) in Part A

Time frame: 1 day. Mean (Full Range). Unit: mg/kg BW/min

Measure	All Participants in Part A n = 6
Clamp 1 Step 1	3.575 (2.74 to 4.41)
Clamp 1 Step 2	14.829 (9.90 to 19.76)
Clamp 2 Step 1	2.859 (2.24 to 3.47)

Population analysed: All participants randomized and who had at least one euglycemic hyperinsulinemic clamp.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to follow-up (up to approximately 3 days after the last clamp procedure in Part A and up to approximately 10 to 14 days after the last study drug administration in Part B). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants in Part A	0 of 6 (0%)	0 of 6 (0%)	Not reported
PF-05175157 200 mg Twice a Day - Part B	1 of 7 (14.3%)	5 of 7 (71.4%)	Not reported
Placebo - Part B	0 of 6 (0%)	1 of 6 (16.7%)	Not reported

Limitations and caveats (from the sponsor): Part B of the study was terminated due to the safety issue. Due to the low number of participants who completed the study, there are no conclusions for PK or PD in Part B. The prioritization of Part A endpoints was done by inputs from team.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
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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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

1 site 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-05175157 in people with Diabetes Mellitus, Type 2, run by Pfizer at 1 site 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 16 Feb 2017). 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?

Glucose Infusion Rates (GIR) in Part A (time frame: 1 day). The study lists 11 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 NCT01792635.

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 16 Feb 2017.