Recent Updates
Recently added Catalysts

PF-04991532

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Oct 30, 2013

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment383

FDA Designations

No designations recorded

Clinical trial landscape

PF-04991532 · 8 trials · 6 indications

Phase 2 2Phase 1 6
NCT01336738Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes MellitusDiabetes, Type 2
COMPLETED266 Analytics
NCT01338870Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED301 Analytics
PHASE2COMPLETED
Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
Diabetes, Type 2
NCT01336738266
Unlock trial analytics
PHASE2COMPLETED
Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes
Diabetes Mellitus, Type 2
NCT01338870301
Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Baseline, Week 12

HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.

Change From Baseline (Day -1) in Mean Daily Glucose at Day 14
Baseline: hours -46, -44, -42, -40, -38, -36, -33, -and -30 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 4, 6, 8, 10, 12, 15, and 18 hours after Day 14 morning dose

Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day on Day -1 and Day 14.

Mass Balance: Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.
0-168 hrs
Metabolic Profiling/identification and determination of relative abundance of PF-04991532 and the metabolites of PF-04991532 in plasma, urine, and feces.
0-168 hrs
radioactivity AUC
0-168 hrs
plasma PF-04991532 AUC
0-168 hrs
radioactivity Cmax
0-168 hrs
plasma PF-04991532 Cmax
0-168 hrs
plasma PF-04991532 Tmax
0-168 hrs
radioactivity Tmax
0-168 hrs
plasma PF-04991532 t1/2
0-168 hrs
radioactivity t1/2
0-168 hrs
Area under the plasma concentration versus time curve (AUClast)
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs
Maximum observed plasma concentration (Cmax)
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs
Time of maximum observed plasma concentration (Tmax)
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs
Renal Clearance (Clr)
0 to 24 hours
Amount of drug excreted (Ae)
0 to 24 hours
Maximum Plasma Concentration (Cmax)
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours post dose
Time for Cmax (Tmax)
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours
Area under the plasma concentration-time profile from time zero to 24 hours (AUC0-24)
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours
Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose (Ae24%)
Urine collection from 0 to 24 hours post dose
Safety Endpoints: Safety and tolerability of PF-04991532 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, and clinical safety laboratory measurements.
5 months
Single-Dose PK Endpoints for PF-04991352: Cmax, Tmax, and AUC(0-tau).
5 months
Multiple-Dose PK Endpoints for PF-04991532: Cmax(ss), Tmax(ss), AUC(0-tau,ss), AUC(0-last), half-life, Cmin(ss), Cav(ss), Ae%, CL/F, Vz/F, CLrenal; accumulation ratios AUC(0-tau,ss)/AUC(0-tau,sd) and Cmax(ss)/Cmax(sd), as the data permit.
5 months
PD Endpoint: glucose excursion (change from Day -1 baseline) in response to a liquid meal test (MMTT) on Days 1 and 14.
5 months
Safety and Tolerability Endpoints: physical exams, AE monitoring, 12-lead ECGs, continuous cardiac monitoring, vital sign and clinical safety laboratory (including frequent glucose assessments via glucometer) measurements.
1 month
PK Endpoints: AUC(0-inf), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), as the data permit.
1 month

Secondary Endpoints

Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
Baseline, Week 1, 2, 4, 8
Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels
Week 12
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORMatching placebo for PF-04991532 and Sitagliptin
150 mg PF-04991532EXPERIMENTAL -
450 mg PF-04991532EXPERIMENTAL -
750 mg PF-04991532EXPERIMENTAL -
Sitagliptin 100 mgACTIVE_COMPARATOR -
25 mg PF-04991532EXPERIMENTAL -
75 mg PF-04991532EXPERIMENTAL -
300 mg PF-04991532EXPERIMENTAL -
PF-04991532EXPERIMENTALPF-04991532 experimental study medication
1EXPERIMENTAL -
healthy controlsEXPERIMENTALhealthy subjects (creatinine clearance \> 90 mL/min)
ESRD / severe renal insufficiencyEXPERIMENTALSevere (creatinine clearance 15 to 29 mL/min) OR ESRD (creatinine clearnace \<15 mL/min OR requiring dialysis)
Moderate renal impairmentEXPERIMENTALModerate (creatinine clearance = 30 to 59 mL/min)
Mild renal impairmentEXPERIMENTALMild (creatinine clearance = 60 to 89 mL/min)
Japanese cohortEXPERIMENTALA total of 12 Japanese healthy subjects will be allocated to receive 3 ascending single doses (100 mg, 300 mg and 750 mg) of PF-04991532 or placebo through 3 dosing periods in a randomization ratio of 3:1.
Weterner CohortEXPERIMENTAL9 western healthy subjects will be enrolled to receive 2 single ascending doses (300 mg and 750 mg) of PF-04991532 through 2 dosing periods.

Interventions

NameTypeDescription
PlaceboDRUGTablets (n=6), 0 mg, once daily for 84 days
150 mg PF-04991532DRUGTablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days
450 mg PF-04991532DRUGTablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days
750 mg PF-04991532DRUGTablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days
Sitagliptin 100 mgDRUGTablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days
25 mg PF-04991532DRUGTablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days
75 mg PF-04991532DRUGTablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days
300 mg PF-04991532DRUGTablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days
PF-04991532DRUGOral administration of PF-04991532; 25 mg given twice a day (BID) for 14 days
PF-0499132DRUGOral administration of PF-04991532; 300 mg given twice a day (BID) for 14 days
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2 Exclusion Criteria: Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pr...

Countries:United StatesCanadaHungaryMexicoSlovakiaSouth KoreaTaiwanJapan
Unlock Eligibility Criteria

Frequently asked questions about PF-04991532

What is PF-04991532 used for?

PF-04991532 is an investigational small molecule being developed for Type 2 Diabetes Mellitus. It has been studied in patients with Type 2 diabetes and in healthy volunteers to evaluate its safety, efficacy, and pharmacokinetics. The drug is in clinical development but is not approved.

Who makes PF-04991532?

PF-04991532 is being developed by Pfizer, Inc., a company publicly traded under the ticker symbol PFE. Pfizer has sponsored multiple clinical trials of this investigational drug for Type 2 Diabetes Mellitus.

What phase is PF-04991532 in?

PF-04991532 has completed Phase 1 and Phase 2 clinical trials. The most advanced trial was a Phase 2 study in subjects with Type 2 Diabetes. The drug is investigational and not yet approved for any use.

What clinical trials is PF-04991532 in?

PF-04991532 has been studied in three completed trials: NCT01129258, a multiple dose study in Type 2 diabetes patients; NCT01338870, a Phase 2 safety and efficacy study; and NCT01369602, a renal impairment pharmacokinetic study. All trials are completed.

Is PF-04991532 the same as any other drug?

No alternative names for PF-04991532 have been reported. The drug is identified solely by its Pfizer code number, PF-04991532, in clinical trial registries and publications.