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NCT02211261

A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus

Completed Phase 1 Results posted Last updated 16 October 2018
What this trial tests

Phase 1 trial testing PF-06293620 in Type 2 Diabetes Mellitus in 84 participants. Completed in 27 January 2017.

Timeline
15 September 2014
Primary endpoint
27 January 2017
27 January 2017

Quick facts

Lead sponsorPfizer
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposebasic science
Enrollment84
Start date15 September 2014
Primary completion27 January 2017
Estimated completion27 January 2017
Sites7 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 70, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events Primary · Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) o

All-causality AE
GroupValue95% CI
Placebo SC (SAD Cohorts)5
PF-06293620 0.3 mg/kg SC (SAD Cohorts)3
PF-06293620 1.0 mg/kg SC (SAD Cohorts)3
PF-06293620 3.0 mg/kg SC (SAD Cohorts)5
PF-06293620 6.0 mg/kg SC (SAD Cohorts)5
Placebo IV (SAD Cohorts)0
PF-06293620 1.0 mg/kg IV (SAD Cohorts)3
Placebo SC (MAD Cohorts)4
PF-06293620 50 mg SC (MAD Cohorts)4
PF-06293620 75 mg SC (MAD Cohorts)11
PF-06293620 150 mg SC (MAD Cohorts)8
All-causality SAE
GroupValue95% CI
Placebo SC (SAD Cohorts)0
PF-06293620 0.3 mg/kg SC (SAD Cohorts)1
PF-06293620 1.0 mg/kg SC (SAD Cohorts)0
PF-06293620 3.0 mg/kg SC (SAD Cohorts)0
PF-06293620 6.0 mg/kg SC (SAD Cohorts)0
Placebo IV (SAD Cohorts)0
PF-06293620 1.0 mg/kg IV (SAD Cohorts)0
Placebo SC (MAD Cohorts)0
PF-06293620 50 mg SC (MAD Cohorts)0
PF-06293620 75 mg SC (MAD Cohorts)1
PF-06293620 150 mg SC (MAD Cohorts)2
Treatment-related AE
GroupValue95% CI
Placebo SC (SAD Cohorts)1
PF-06293620 0.3 mg/kg SC (SAD Cohorts)0
PF-06293620 1.0 mg/kg SC (SAD Cohorts)0
PF-06293620 3.0 mg/kg SC (SAD Cohorts)3
PF-06293620 6.0 mg/kg SC (SAD Cohorts)3
Placebo IV (SAD Cohorts)0
PF-06293620 1.0 mg/kg IV (SAD Cohorts)1
Placebo SC (MAD Cohorts)1
PF-06293620 50 mg SC (MAD Cohorts)1
PF-06293620 75 mg SC (MAD Cohorts)4
PF-06293620 150 mg SC (MAD Cohorts)5
Treatment-related SAE
GroupValue95% CI
Placebo SC (SAD Cohorts)0
PF-06293620 0.3 mg/kg SC (SAD Cohorts)0
PF-06293620 1.0 mg/kg SC (SAD Cohorts)0
PF-06293620 3.0 mg/kg SC (SAD Cohorts)0
PF-06293620 6.0 mg/kg SC (SAD Cohorts)0
Placebo IV (SAD Cohorts)0
PF-06293620 1.0 mg/kg IV (SAD Cohorts)0
Placebo SC (MAD Cohorts)0
PF-06293620 50 mg SC (MAD Cohorts)0
PF-06293620 75 mg SC (MAD Cohorts)0
PF-06293620 150 mg SC (MAD Cohorts)0
Number of Participants With Positive Anti-drug Antibody (ADA) Result Primary · Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts

ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer \>=1.88 was considered positive.

GroupValue95% CI
Placebo SC (SAD Cohorts)1
PF-06293620 0.3 mg/kg SC (SAD Cohorts)5
PF-06293620 1.0 mg/kg SC (SAD Cohorts)2
PF-06293620 3.0 mg/kg SC (SAD Cohorts)1
PF-06293620 6.0 mg/kg SC (SAD Cohorts)2
Placebo IV (SAD Cohorts)0
PF-06293620 1.0 mg/kg IV (SAD Cohorts)1
Placebo SC (MAD Cohorts)0
PF-06293620 50 mg SC (MAD Cohorts)5
PF-06293620 75 mg SC (MAD Cohorts)7
PF-06293620 150 mg SC (MAD Cohorts)4
Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts) Secondary · Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85

AUCinf was calculated as AUClast +(Clast\*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.

GroupValue95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)300± NA
PF-06293620 1.0 mg/kg SC (SAD Cohorts)1716± 46
PF-06293620 3.0 mg/kg SC (SAD Cohorts)6306± 54
PF-06293620 6.0 mg/kg SC (SAD Cohorts)19440± 56
PF-06293620 1.0 mg/kg IV (SAD Cohorts)6775± 12
Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts) Secondary · Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85

AUCinf(dn) was calculated as AUCinf/dose, where AUCinf is area under the serum concentration-time profile from time 0 extrapolated to infinite time.

GroupValue95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)12.00± NA
PF-06293620 1.0 mg/kg SC (SAD Cohorts)22.24± 45
PF-06293620 3.0 mg/kg SC (SAD Cohorts)23.79± 47
PF-06293620 6.0 mg/kg SC (SAD Cohorts)36.13± 49
PF-06293620 1.0 mg/kg IV (SAD Cohorts)67.94± 16
Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts) Secondary · Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85

Area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06293620 was determined using linear/log trapezoidal method.

GroupValue95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)128.3± 54
PF-06293620 1.0 mg/kg SC (SAD Cohorts)1619± 46
PF-06293620 3.0 mg/kg SC (SAD Cohorts)5945± 53
PF-06293620 6.0 mg/kg SC (SAD Cohorts)18080± 58
PF-06293620 1.0 mg/kg IV (SAD Cohorts)6509± 13
Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts) Secondary · Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85

AUClast(dn) of PF-06293620 was calculated as AUClast/dose, where AUClast was area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration.

GroupValue95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)4.779± 58
PF-06293620 1.0 mg/kg SC (SAD Cohorts)21.01± 44
PF-06293620 3.0 mg/kg SC (SAD Cohorts)22.47± 47
PF-06293620 6.0 mg/kg SC (SAD Cohorts)33.59± 50
PF-06293620 1.0 mg/kg IV (SAD Cohorts)65.26± 18
Clearance (CL) of PF-06293620 (SAD Cohorts) Secondary · Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85

Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms.

GroupValue95% CI
PF-06293620 1.0 mg/kg IV (SAD Cohorts)14.72± 16
Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts) Secondary · Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85

Apparent Clearance (CL/F) of PF-06293620 was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arms.

GroupValue95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)83.20± NA
PF-06293620 1.0 mg/kg SC (SAD Cohorts)44.93± 45
PF-06293620 3.0 mg/kg SC (SAD Cohorts)42.05± 47
PF-06293620 6.0 mg/kg SC (SAD Cohorts)27.67± 49
Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts) Secondary · Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85

Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data.

GroupValue95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)0.3907± 58
PF-06293620 1.0 mg/kg SC (SAD Cohorts)2.896± 48
PF-06293620 3.0 mg/kg SC (SAD Cohorts)7.222± 52
PF-06293620 6.0 mg/kg SC (SAD Cohorts)22.30± 62
PF-06293620 1.0 mg/kg IV (SAD Cohorts)27.64± 20
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts) Secondary · Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85

Time for Maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.

GroupValue95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)16871.9 – 336
PF-06293620 1.0 mg/kg SC (SAD Cohorts)16848.0 – 504
PF-06293620 3.0 mg/kg SC (SAD Cohorts)25295.9 – 504
PF-06293620 6.0 mg/kg SC (SAD Cohorts)16896.0 – 504
PF-06293620 1.0 mg/kg IV (SAD Cohorts)1.001.00 – 2.00
Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts) Secondary · Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85

Steady-state volume of distribution (Vss) of PF-06293620 was calculated as CL\*MRT, where MRT was the mean residence time calculated as (AUMCinf/AUCinf - infusion duration/2), AUMCinf was area under the moment curve from time 0 extrapolated to infinity; CL was the clearance. This outcome measure only applies to IV arms.

GroupValue95% CI
PF-06293620 1.0 mg/kg IV (SAD Cohorts)7.0951.00 – 2.00
Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts) Secondary · Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85

Apparent Volume of Distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCinf\*kel), where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. This outcome measure only applies to SC arms.

GroupValue95% CI
PF-06293620 0.3 mg/kg SC (SAD Cohorts)21.10± NA
PF-06293620 1.0 mg/kg SC (SAD Cohorts)16.25± 43
PF-06293620 3.0 mg/kg SC (SAD Cohorts)20.63± 44
PF-06293620 6.0 mg/kg SC (SAD Cohorts)18.17± 48

Adverse events — posted to ClinicalTrials.gov

Time frame: Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo SC (SAD Cohorts)
Serious: 0/9 (0%)
Deaths: 0/9
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
Serious: 1/6 (17%)
Deaths: 0/6
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
Serious: 0/6 (0%)
Deaths: 0/6
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
Serious: 0/6 (0%)
Deaths: 0/6
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
Serious: 0/9 (0%)
Deaths: 0/9
Placebo IV (SAD Cohorts)
Serious: 0/2 (0%)
Deaths: 0/2
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Serious: 0/6 (0%)
Deaths: 0/6
Placebo SC (MAD Cohorts)
Serious: 0/8 (0%)
Deaths: 0/8
PF-06293620 50 mg SC (MAD Cohorts)
Serious: 0/8 (0%)
Deaths: 0/8
PF-06293620 75 mg SC (MAD Cohorts)
Serious: 1/16 (6%)
Deaths: 0/16
PF-06293620 150 mg SC (MAD Cohorts)
Serious: 2/8 (25%)
Deaths: 0/8

Serious adverse events (4 terms)

ReactionSystemPlacebo SC (SAD Cohorts)PF-06293620 0.3 mg/kg SC (…PF-06293620 1.0 mg/kg SC (…PF-06293620 3.0 mg/kg SC (…PF-06293620 6.0 mg/kg SC (…Placebo IV (SAD Cohorts)PF-06293620 1.0 mg/kg IV (…Placebo SC (MAD Cohorts)PF-06293620 50 mg SC (MAD …PF-06293620 75 mg SC (MAD …PF-06293620 150 mg SC (MAD…
CholelithiasisHepatobiliary disorders
Angina unstableCardiac disorders
Coronary artery diseaseCardiac disorders
Joint injuryInjury, poisoning and procedural complications
Other adverse events (60 terms — click to expand)

ReactionSystemPlacebo SC (SAD Cohorts)PF-06293620 0.3 mg/kg SC (…PF-06293620 1.0 mg/kg SC (…PF-06293620 3.0 mg/kg SC (…PF-06293620 6.0 mg/kg SC (…Placebo IV (SAD Cohorts)PF-06293620 1.0 mg/kg IV (…Placebo SC (MAD Cohorts)PF-06293620 50 mg SC (MAD …PF-06293620 75 mg SC (MAD …PF-06293620 150 mg SC (MAD…
Liver function test increasedInvestigations
Iron deficiency anaemiaBlood and lymphatic system disorders
DiarrhoeaGastrointestinal disorders
FallInjury, poisoning and procedural complications
EcchymosisSkin and subcutaneous tissue disorders
Abdominal distensionGastrointestinal disorders
Abdominal painGastrointestinal disorders
Abdominal pain lowerGastrointestinal disorders
Abdominal pain upperGastrointestinal disorders
ConstipationGastrointestinal disorders
Dry mouthGastrointestinal disorders
FlatulenceGastrointestinal disorders
Gastrooesophageal reflux diseaseGastrointestinal disorders
ToothacheGastrointestinal disorders
VomitingGastrointestinal disorders
AstheniaGeneral disorders
HungerGeneral disorders
Infusion site extravasationGeneral disorders
Infusion site hemorrhageGeneral disorders
Injection site pruritusGeneral disorders
MalaiseGeneral disorders
Biliary colicHepatobiliary disorders
NauseaGastrointestinal disorders
CholelithiasisHepatobiliary disorders
Body tineaInfections and infestations
BronchitisInfections and infestations
CellulitisInfections and infestations
Infective glossitisInfections and infestations
InfluenzaInfections and infestations
PharyngitisInfections and infestations
Upper respiratory tract infectionInfections and infestations
Viral pharyngitisInfections and infestations
SinusitisInfections and infestations
Viral infectionInfections and infestations
Viral upper respiratory tract infectionInfections and infestations
Blood creatine phosphokinase increasedInvestigations
Blood pressure increasedInvestigations
Haemoglobin decreasedInvestigations
GoutMetabolism and nutrition disorders
Decreased appetiteMetabolism and nutrition disorders

Most-reported serious reactions: Cholelithiasis, Angina unstable, Coronary artery disease, Joint injury.

Data from ClinicalTrials.gov NCT02211261 adverse events section.

Sponsor's own description

A first in human study to determine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Pancreatic endocrine and exocrine signaling and crosstalk in physiological and pathological status.
    Hu C, Chen Y, Yin X, Xu R, et al · · 2025 · cited 25× · PMID 39948335 · DOI 10.1038/s41392-024-02098-3
  2. The Role of the α Cell in the Pathogenesis of Diabetes: A World beyond the Mirror.
    Martínez MS, Manzano A, Olivar LC, Nava M, et al · · 2021 · cited 18× · PMID 34502413 · DOI 10.3390/ijms22179504

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02211261.

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