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TerminatedNCT01792635Updated Feb 16, 2017Results posted

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

A Phase 2 interventional study of PF-05175157 and Placebo in Diabetes Mellitus, Type 2, sponsored by Pfizer. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-02-16.

Sponsored by Pfizer · Phase 2, Interventional, and Basic science

Why this study was terminated
The study was terminated prematurely on 16 May 2014 due to a safety concern.
Phase
Phase 2
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Type 2 Diabetes Mellitus
  • Pharmacodynamics
  • Safety & Tolerability
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 19 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
19 participants (actual)

Study arms

  • No intervention
    Part A (Pilot Study)
  • Experimental
    Monotherapy (Part B)

    Drug: PF-05175157 · Drug: Placebo

Interventions

  • DrugPF-05175157

    PF-05175157 will be administered at 200 mg twice a day for 43 days.

  • DrugPlacebo

    Placebo tablets matched to PF-05175157 will be administered twice a day for 43 days.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. 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).

    Time frame: 1 day

  3. [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.

    Time frame: 1 day

  4. 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).

    Time frame: 1 day

  5. Whole-body Glucose Uptake in Part A

    Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp

    Time frame: 1 day

  6. Whole-body Glucose Uptake in Part B in Placebo Group

    Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp

    Time frame: 6 weeks

  7. 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

    Time frame: 6 weeks

  8. 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.

    Time frame: Baseline to follow-up (up to approximately 10 to 14 days after the last study drug administration)

  9. 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).

    Time frame: Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)

  10. 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).

    Time frame: Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)

  11. 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.

    Time frame: Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)

Secondary outcomes

  1. 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.

    Time frame: 6 weeks

  2. 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.

    Time frame: 6 weeks

  3. 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)

    Time frame: 6 weeks

  4. 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)

    Time frame: 6 weeks

  5. Ra in Part B in Placebo Group

    Ra in fasting state and during insulin infusions (Step 1 and Step 2).

    Time frame: 6 weeks

  6. Ra in Part B in PF-05175157 200 mg BID Group

    Ra in fasting state and during insulin infusions (Step 1 and Step 2).

    Time frame: 6 weeks

07

Results

Posted Feb 16, 2017
Limitations and caveats
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.

Participant flow

Part A
Participant flow — Part A
MilestoneAll Participants in Part APlacebo - Part BPF-05175157 200 mg Twice a Day - Part B
Started600
Completed600
Not completed000
Part B
Participant flow — Part B
MilestoneAll Participants in Part APlacebo - Part BPF-05175157 200 mg Twice a Day - Part B
Started067
Completed023
Not completed044
Withdrew: Adverse event001
Withdrew: Study terminated043

Outcome measures

PrimaryGlucose 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.

Time frame:
1 day
Reported as:
Mean · mg/min
Glucose Infusion Rates (GIR) in Part A
mg/minAll Participants in Part A
Clamp 1 GIR1191 (153 to 229)
Clamp 1 GIR2780 (580 to 980)
Clamp 2 GIR1152 (132 to 172)
PrimaryEndogenous 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).

Time frame:
1 day
Reported as:
Median · mg/kilogram (kg) body weight (BW)/min
Endogenous Gucose Production (EGP) in Part A
mg/kilogram (kg) body weight (BW)/minAll Participants in Part A
Clamp 1 EGP01.79 (1.48 to 1.99)
Clamp 1 EGP10.85 (0.51 to 0.98)
Clamp 1 EGP20.07 (-0.02 to 0.36)
Clamp 2 EGP01.68 (1.59 to 1.89)
Clamp 2 EGP10.81 (0.71 to 0.98)
Primary[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.

Time frame:
1 day
Reported as:
Mean · percentage enrichment of plasma glucose
[6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A
percentage enrichment of plasma glucoseAll Participants in Part A
Clamp 12.96 (2.94 to 2.98)
Clamp 22.97 (2.88 to 3.06)
PrimaryRate 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).

Time frame:
1 day
Reported as:
Mean · mg/kg BW/min
Rate of Appearance of Glucose (Ra) in Part A
mg/kg BW/minAll Participants in Part A
Clamp 1 Step 13.575 (2.74 to 4.41)
Clamp 1 Step 214.829 (9.90 to 19.76)
Clamp 2 Step 12.859 (2.24 to 3.47)
PrimaryWhole-body Glucose Uptake in Part A

Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp

Time frame:
1 day
Reported as:
Mean · mg/kg BW/min
Whole-body Glucose Uptake in Part A
mg/kg BW/minAll Participants in Part A
Whole-body Glucose Uptake in Part A14.829 (9.90 to 19.76)
PrimaryWhole-body Glucose Uptake in Part B in Placebo Group

Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp

Time frame:
6 weeks
Reported as:
Mean · mg/kg BW/min
Whole-body Glucose Uptake in Part B in Placebo Group
mg/kg BW/minPlacebo - Part B
Step 2 Value 14.245 (4.18 to 4.41)
Step 2 Value 26.325 (6.26 to 6.45)
Step 2 Value 32.793 (2.72 to 2.85)
Step 2 Value 46.835 (6.56 to 7.38)
Step 2 Value 54.400 (3.97 to 5.23)
Step 2 Value 63.940 (3.86 to 3.98)
Step 2 Value 74.553 (4.37 to 4.62)
Step 2 Value 84.225 (4.16 to 4.40)
PrimaryWhole-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

Time frame:
6 weeks
Reported as:
Mean · mg/kg BW/min
Whole-body Glucose Uptake in Part B in PF-05175157 200 mg BID Group
mg/kg BW/minPF-05175157 200 mg Twice a Day - Part B
Step 2 Value 13.775 (3.70 to 3.83)
Step 2 Value 29.033 (8.95 to 9.08)
Step 2 Value 38.903 (8.33 to 9.37)
Step 2 Value 411.310 (11.13 to 11.47)
Step 2 Value 54.133 (3.98 to 4.50)
Step 2 Value 66.763 (5.98 to 7.93)
Step 2 Value 78.243 (8.06 to 8.73)
Step 2 Value 87.180 (7.03 to 7.39)
Step 2 Value 910.113 (9.80 to 10.28)
Step 2 Value 106.205 (6.16 to 6.31)
PrimaryNumber 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.

Time frame:
Baseline to follow-up (up to approximately 10 to 14 days after the last study drug administration)
Reported as:
Number · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) in Part B
ParticipantsPlacebo - Part BPF-05175157 200 mg Twice a Day - Part B
Participants w ith AEs15
Participants w ith SAEs01
Participants discontinued due to AEs01
PrimaryNumber 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).

Time frame:
Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)
Reported as:
Number · Participants
Number of Participants With Laboratory Test Abnormalities in Part B
ParticipantsPlacebo - Part BPF-05175157 200 mg Twice a Day - Part B
Number of Participants With Laboratory Test Abnormalities in Part B67
PrimaryNumber 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).

Time frame:
Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)
Reported as:
Number · Participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria in Part B
ParticipantsPlacebo - Part BPF-05175157 200 mg Twice a Day - Part B
SBP <90 mm Hg00
DBP <50 mm Hg00
Pulse Rate <40 bpm00
Pulse Rate >120 bpm00
SBP maximum increase from baseline >=30 mm Hg00
DBP maximum increase from baseline >=20 mm Hg00
SBP maximum decrease from baseline >=30 mm Hg01
DBP maximum decrease from baseline >=20 mm Hg00
PrimaryNumber 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.

Time frame:
Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)
Reported as:
Number · Participants
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarisation Criteria in Part B
ParticipantsPlacebo - Part BPF-05175157 200 mg Twice a Day - Part B
QTc increase from Baseline of >=60 msec01
QTcF increase from Baseline of >=60 msec01
SecondaryGIR 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.

Time frame:
6 weeks
Reported as:
Mean · mg/min
GIR in Part B in Placebo Group
mg/minPlacebo - Part B
GIR1 Value 1139.4 (0 to 150)
GIR1 Value 2178.3 (176 to 246)
GIR1 Value 352.4 (0 to 97)
GIR1 Value 4196.5 (181 to 197)
GIR1 Value 5145.7 (92 to 161)
GIR1 Value 6104.7 (103 to 140)
GIR1 Value 7154.7 (143 to 218)
GIR1 Value 885.4 (68 to 86)
GIR2 Value 1413.9 (411 to 461)
GIR2 Value 2645.0 (645 to 645)
GIR2 Value 3293.4 (217 to 296)
GIR2 Value 4668.2 (610 to 711)
GIR2 Value 5400.4 (368 to 504)
GIR2 Value 6359.3 (289 to 363)
GIR2 Value 7338.0 (338 to 338)
GIR2 Value 8343.3 (322 to 344)
SecondaryGIR 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.

Time frame:
6 weeks
Reported as:
Mean · mg/min
GIR in Part B in PF-05175157 200 mg BID Group
mg/minPF-05175157 200 mg Twice a Day - Part B
GIR1 Value 1170.5 (118 to 191)
GIR1 Value 2425.0 (367 to 427)
GIR1 Value 3334.2 (311 to 335)
GIR1 Value 4409.3 (277 to 521)
GIR1 Value 550.0 (50 to 50)
GIR1 Value 6160.9 (160 to 188)
GIR1 Value 7113.2 (68 to 116)
GIR1 Value 8157.7 (113 to 225)
GIR1 Value 9215.2 (201 to 236)
GIR1 Value 10159.9 (159 to 178)
GIR2 Value 1359.2 (270 to 368)
GIR2 Value 2896.5 (871 to 921)
GIR2 Value 3896.3 (864 to 1064)
GIR2 Value 41078.5 (1068 to 1079)
GIR2 Value 5357.6 (357 to 370)
GIR2 Value 6564.0 (520 to 656)
GIR2 Value 7693.1 (666 to 728)
GIR2 Value 8647.2 (623 to 681)
GIR2 Value 9889.4 (821 to 893)
GIR2 Value 10519.5 (512 to 540)
SecondaryEGP 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)

Time frame:
6 weeks
Reported as:
Median · mg/kg fat free mass (FFM)/min
EGP in Part B in Placebo Group
mg/kg fat free mass (FFM)/minPlacebo - Part B
EGP0 Value 11.540 (1.49 to 1.60)
EGP0 Value 21.690 (1.64 to 1.75)
EGP0 Value 31.285 (1.24 to 1.33)
EGP0 Value 41.575 (1.55 to 1.62)
EGP0 Value 51.965 (1.89 to 2.04)
EGP0 Value 61.538 (1.50 to 1.58)
EGP0 Value 71.518 (1.47 to 1.56)
EGP0 Value 81.518 (1.49 to 1.56)
EGP1 Value 10.600 (0.57 to 0.66)
EGP1 Value 20.585 (0.55 to 0.61)
EGP1 Value 30.525 (0.49 to 0.59)
EGP1 Value 40.500 (0.49 to 0.52)
EGP1 Value 50.808 (0.75 to 0.86)
EGP1 Value 60.830 (0.82 to 0.84)
EGP1 Value 70.560 (0.55 to 0.58)
EGP1 Value 80.825 (0.78 to 0.85)
EGP2 Value 10.200 (0.17 to 0.22)
EGP2 Value 2-0.063 (-0.09 to -0.03)
EGP2 Value 3-0.050 (-0.10 to -0.01)
EGP2 Value 40.280 (0.25 to 0.31)
EGP2 Value 50.145 (0.06 to 0.23)
EGP2 Value 60.223 (0.20 to 0.24)
EGP2 Value 70.180 (0.17 to 0.19)
EGP2 Value 80.405 (0.38 to 0.46)
SecondaryEGP 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)

Time frame:
6 weeks
Reported as:
Median · mg/kg fat free mass (FFM)/min
EGP in Part B in PF-05175157 200 mg BID Group
mg/kg fat free mass (FFM)/minPF-05175157 200 mg Twice a Day - Part B
EGP0 Value 11.240 (1.23 to 1.27)
EGP0 Value 21.445 (1.42 to 1.46)
EGP0 Value 32.083 (2.03 to 2.15)
EGP0 Value 41.708 (1.68 to 1.73)
EGP0 Value 51.695 (1.67 to 1.72)
EGP0 Value 61.615 (1.59 to 1.65)
EGP0 Value 71.690 (1.64 to 1.75)
EGP0 Value 81.393 (1.25 to 1.46)
EGP0 Value 91.448 (1.43 to 1.46)
EGP0 Value 101.345 (1.33 to 1.36)
EGP1 Value 10.568 (0.54 to 0.59)
EGP1 Value 20.250 (0.22 to 0.28)
EGP1 Value 30.788 (0.69 to 0.89)
EGP1 Value 40.575 (0.54 to 0.62)
EGP1 Value 51.183 (1.12 to 1.22)
EGP1 Value 60.538 (0.52 to 0.55)
EGP1 Value 70.765 (0.74 to 0.78)
EGP1 Value 80.555 (0.53 to 0.58)
EGP1 Value 90.193 (0.11 to 0.23)
EGP1 Value 100.418 (0.35 to 0.45)
EGP2 Value 10.253 (0.23 to 0.29)
EGP2 Value 20.165 (0.09 to 0.21)
EGP2 Value 3-0.035 (-0.43 to 0.14)
EGP2 Value 40.243 (0.10 to 0.39)
EGP2 Value 50.543 (0.47 to 0.67)
EGP2 Value 60.110 (0.03 to 0.15)
EGP2 Value 70.190 (0.15 to 0.24)
EGP2 Value 8-0.313 (-0.42 to -0.23)
EGP2 Value 9-0.253 (-0.34 to -0.20)
EGP2 Value 100.198 (0.19 to 0.21)
SecondaryRa in Part B in Placebo Group

Ra in fasting state and during insulin infusions (Step 1 and Step 2).

Time frame:
6 weeks
Reported as:
Mean · mg/kg BW/min
Ra in Part B in Placebo Group
mg/kg BW/minPlacebo - Part B
Step 2 Value 14.245 (4.18 to 4.41)
Step 2 Value 26.325 (6.26 to 6.45)
Step 2 Value 32.793 (2.72 to 2.85)
Step 2 Value 46.835 (6.56 to 7.38)
Step 2 Value 54.400 (3.97 to 5.23)
Step 2 Value 63.940 (3.86 to 3.98)
Step 2 Value 74.553 (4.37 to 4.62)
Step 2 Value 84.225 (4.16 to 4.40)
SecondaryRa in Part B in PF-05175157 200 mg BID Group

Ra in fasting state and during insulin infusions (Step 1 and Step 2).

Time frame:
6 weeks
Reported as:
Mean · mg/kg BW/min
Ra in Part B in PF-05175157 200 mg BID Group
mg/kg BW/minPF-05175157 200 mg Twice a Day - Part B
Step 2 Value 13.775 (3.70 to 3.83)
Step 2 Value 29.033 (8.95 to 9.08)
Step 2 Value 38.903 (8.33 to 9.37)
Step 2 Value 411.310 (11.13 to 11.47)
Step 2 Value 54.133 (3.98 to 4.50)
Step 2 Value 66.763 (5.98 to 7.93)
Step 2 Value 78.243 (8.06 to 8.73)
Step 2 Value 87.180 (7.03 to 7.39)
Step 2 Value 910.113 (9.80 to 10.28)
Step 2 Value 106.205 (6.16 to 6.31)

Adverse events

Collected over 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). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Participants in Part A—0/6 (0%)0/6 (0%)
PF-05175157 200 mg Twice a Day - Part B—1/7 (14.3%)5/7 (71.4%)
Placebo - Part B—0/6 (0%)1/6 (16.7%)
Most frequent serious events
Most frequent serious events
EventAll Participants in Part APF-05175157 200 mg Twice a Day - Part BPlacebo - Part B
ThrombocytopeniaBlood and lymphatic system disorders0/61/70/6
Most frequent other events
Most frequent other events
EventAll Participants in Part APF-05175157 200 mg Twice a Day - Part BPlacebo - Part B
PruritusSkin and subcutaneous tissue disorders0/61/71/6
Lacrimation increasedEye disorders0/61/70/6
ConstipationGastrointestinal disorders0/61/70/6
Upper respiratory tract infectionInfections and infestations0/61/70/6
Decreased appetiteMetabolism and nutrition disorders0/61/70/6
HyperglycaemiaMetabolism and nutrition disorders0/61/70/6
BlisterSkin and subcutaneous tissue disorders0/61/70/6

Baseline characteristics

Age, Continuous
Age, Continuous(Years)All Participants in Part APlacebo - Part BPF-05175157 200 mg Twice a Day - Part BTotal
Mean50.7 ± 9.549.3 ± 9.255.1 ± 4.651.9 ± 7.9
Sex/Gender, Customized
Sex/Gender, Customized(Participants)All Participants in Part APlacebo - Part BPF-05175157 200 mg Twice a Day - Part BTotal
Male55515
Female1124
08

Study locations

1 site
  • Profil Institute for Clinical Research, Inc.
    Chula Vista, California 91911, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01792635
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Feb 15, 2013
Start date
Dec 2012
Primary completion
May 2014
Completion
May 2014
Results posted
Feb 16, 2017
Last update
Feb 16, 2017

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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