NCT01856595 is a Phase 1 clinical trial of PF-06291874 in Diabetes Mellitus, Type 2, sponsored by Pfizer.

Who is sponsoring NCT01856595?

NCT01856595 is sponsored by Pfizer.

What drugs are being tested in NCT01856595?

Interventions in NCT01856595: PF-06291874, Placebo.

What condition does NCT01856595 study?

NCT01856595 studies Diabetes Mellitus, Type 2.

Is NCT01856595 still recruiting?

NCT01856595 is currently completed. Last updated 1 November 2018.

Are results published for NCT01856595?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-11-01 · How we verify

NCT01856595

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PF-06291874 Multiple Ascending Dose Study In Type 2 Diabetes Mellitus Patients

Completed Phase 1 Results posted Last updated 1 November 2018

What this trial tests

Phase 1 trial testing PF-06291874 in Diabetes Mellitus, Type 2 in 117 participants. Completed in 1 March 2014.

Timeline

13 May 2013

Primary endpoint
10 January 2014

1 March 2014

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	117
Start date	13 May 2013
Primary completion	10 January 2014
Estimated completion	1 March 2014
Sites	3 locations across United States

Drugs / interventions tested

PF-06291874 — full drug profile →
Placebo

Conditions studied

Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 70, any sex, with Diabetes Mellitus, Type 2. 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 Had Protocol-Defined Total Hypoglycemic Adverse Event (HAE) - Part A Primary · Day 1 up to 7-11 days after last dose of study drug

A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Hypoglycaemia was assessed and reported in several categories: severe hypoglycaemia, documented symptomatic hypoglycaemia, asymptomatic hypoglycaemia, and probable hypoglycaemia.

Group	Value	95% CI
Placebo	2
PF-06291874 5 mg	2
PF-06291874 15 mg	1
PF-06291874 50 mg	1
PF-06291874 100 mg	1
PF-06291874 150 mg	2

Number of Participants Had Protocol-Defined Total Hypoglycemic Adverse Event (HAE) - Part B Primary · Day 1 up to 7-11 days after last dose of study drug

Group	Value	95% CI
Placebo	7
PF-06291874 15 mg	4
PF-06291874 30 mg	13

Number of Participants With Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern - Part A Primary · Predose (0),4,6,8,12,24 hours on Days 1 and 14; 8 hours post dose on Days 3,7,11 for all Cohorts ; predose on Day 17 for Cohorts 1- 4A and 1B; predose on Days 21 and 28 for Cohorts 5A and 2B.

ECG criteria of potential clinical concern were 1), PR interval: greater than or equal to (\>=)300 milliseconds (msec); \>=25 percent (%) increase when baselinegreater than (\>)200 msec; or increase \>=50% when baseline less than or equal to (\<=)200 msec; 2), QRS interval: \>=140 msec; \>=50% increase from baseline; 3), QT interval: \>=500 msec, QTc interval using cridericia's formula (QTcF interval): absolute value \>=450 - \<480 msec, \>=480-\<500 msec, \>500 msec; absolute change 30 - \<60, \>=60 msec.

PR interval >=300 msec

Group	Value	95% CI
Placebo	0
PF-06291874 5 mg	0
PF-06291874 15 mg	0
PF-06291874 50 mg	0
PF-06291874 100 mg	0
PF-06291874 150 mg	0

QRS interval >=140 msec

Group	Value	95% CI
Placebo	0
PF-06291874 5 mg	0
PF-06291874 15 mg	0
PF-06291874 50 mg	0
PF-06291874 100 mg	0
PF-06291874 150 mg	0

QT interval >=500 msec

Group	Value	95% CI
Placebo	0
PF-06291874 5 mg	0
PF-06291874 15 mg	0
PF-06291874 50 mg	0
PF-06291874 100 mg	0
PF-06291874 150 mg	0

QTcF interval 450-480 msec

Group	Value	95% CI
Placebo	1
PF-06291874 5 mg	0
PF-06291874 15 mg	1
PF-06291874 50 mg	0
PF-06291874 100 mg	0
PF-06291874 150 mg	1

QTcF interval 480-500 msec

Group	Value	95% CI
Placebo	0
PF-06291874 5 mg	0
PF-06291874 15 mg	0
PF-06291874 50 mg	0
PF-06291874 100 mg	0
PF-06291874 150 mg	0

QTcF interval >=500 msec

Group	Value	95% CI
Placebo	0
PF-06291874 5 mg	0
PF-06291874 15 mg	0
PF-06291874 50 mg	0
PF-06291874 100 mg	0
PF-06291874 150 mg	0

PR interval increase ≥25%/50%

Group	Value	95% CI
Placebo	0
PF-06291874 5 mg	0
PF-06291874 15 mg	0
PF-06291874 50 mg	1
PF-06291874 100 mg	0
PF-06291874 150 mg	0

QRS interval increase >=50%

Group	Value	95% CI
Placebo	0
PF-06291874 5 mg	0
PF-06291874 15 mg	0
PF-06291874 50 mg	0
PF-06291874 100 mg	0
PF-06291874 150 mg	0

Number of Participants With ECGs Data Met Criteria of Potential Clinical Concern - Part B Primary · Predose (0),4,6,8,12,24 hours on Days 1 and 14; 8 hours post dose on Days 3,7,11 for all Cohorts ; predose on Day 17 for Cohorts 1- 4A and 1B; predose on Days 21 and 28 for Cohorts 5A and 2B.

ECG criteria of potential clinical concern were 1), PR interval: \>=300 msec; \>=25% increase when baseline \>200 msec; or increase \>=50% when baseline \<=200 msec; 2), QRS interval: \>=140 msec; \>=50% increase from baseline; 3), QT interval: \>=500 msec, QTcF interval: absolute value \>=450 - \<480 msec, \>=480-\<500 msec, \>500 msec; absolute change 30 - \<60, \>=60 msec.

PR interval >=300 msec

Group	Value	95% CI
Placebo	0
PF-06291874 15 mg	0
PF-06291874 30 mg	0

QRS interval >=140 msec

Group	Value	95% CI
Placebo	0
PF-06291874 15 mg	0
PF-06291874 30 mg	0

QT interval >=500 msec

Group	Value	95% CI
Placebo	0
PF-06291874 15 mg	0
PF-06291874 30 mg	0

QTcF interval 450-480 msec

Group	Value	95% CI
Placebo	1
PF-06291874 15 mg	1
PF-06291874 30 mg	2

QTcF interval 480-500 msec

Group	Value	95% CI
Placebo	0
PF-06291874 15 mg	0
PF-06291874 30 mg	0

QTcF interval >=500 msec

Group	Value	95% CI
Placebo	0
PF-06291874 15 mg	0
PF-06291874 30 mg	0

PR interval increase ≥25%/50%

Group	Value	95% CI
Placebo	0
PF-06291874 15 mg	0
PF-06291874 30 mg	0

QRS interval increase >=50%

Group	Value	95% CI
Placebo	0
PF-06291874 15 mg	0
PF-06291874 30 mg	0

Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern - Part A Primary · Predose (0),4,6,8,12,24 hours on Days 1 and 14; 8 hours post dose on Days 3,7,11 for all Cohorts ; predose on Day 17 for Cohorts 1- 4A and 1B; predose on Days 21 and 28 for Cohorts 5A and 2B.

Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic BP (SBP) greater than or equal to (\>=) 30 millimeters of mercury (mm Hg) change from grand baseline in same posture, systolic less than (\<) 90 mm Hg; diastolic BP (DBP) \>=20 mm Hg change from grand baseline in same posture, diastolic \<50 mm Hg; 2), pulse rate (supine): \<40 or greater than (\>) 120 beats per minute (bpm).

Supine SBP <90 mm Hg

Group	Value	95% CI
Placebo	1
PF-06291874 5 mg	0
PF-06291874 15 mg	0
PF-06291874 50 mg	0
PF-06291874 100 mg	1
PF-06291874 150 mg	0

Supine DBP <50 mm Hg

Group	Value	95% CI
Placebo	0
PF-06291874 5 mg	0
PF-06291874 15 mg	0
PF-06291874 50 mg	0
PF-06291874 100 mg	0
PF-06291874 150 mg	0

Supine pulse rate <40 bpm

Group	Value	95% CI
Placebo	0
PF-06291874 5 mg	0
PF-06291874 15 mg	0
PF-06291874 50 mg	0
PF-06291874 100 mg	0
PF-06291874 150 mg	0

Increase:supine SBP≥30 mm Hg

Group	Value	95% CI
Placebo	0
PF-06291874 5 mg	0
PF-06291874 15 mg	1
PF-06291874 50 mg	0
PF-06291874 100 mg	0
PF-06291874 150 mg	0

Increase:supine DBP≥20 mm Hg

Group	Value	95% CI
Placebo	3
PF-06291874 5 mg	0
PF-06291874 15 mg	0
PF-06291874 50 mg	0
PF-06291874 100 mg	7
PF-06291874 150 mg	2

Decrease:supine SBP≥30 mm Hg

Group	Value	95% CI
Placebo	2
PF-06291874 5 mg	1
PF-06291874 15 mg	0
PF-06291874 50 mg	0
PF-06291874 100 mg	0
PF-06291874 150 mg	0

Decrease:supine DBP≥20 mm Hg

Group	Value	95% CI
Placebo	1
PF-06291874 5 mg	3
PF-06291874 15 mg	1
PF-06291874 50 mg	2
PF-06291874 100 mg	0
PF-06291874 150 mg	0

Supine pulse rate >120 bpm

Group	Value	95% CI
Placebo	3
PF-06291874 5 mg	2
PF-06291874 15 mg	1
PF-06291874 50 mg	3
PF-06291874 100 mg	1
PF-06291874 150 mg	0

Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern - Part B Primary · Predose (0),4,6,8,12,24 hours on Days 1 and 14; 8 hours post dose on Days 3,7,11 for all Cohorts ; predose on Day 17 for Cohorts 1- 4A and 1B; predose on Days 21 and 28 for Cohorts 5A and 2B.

Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: SBP \>= 30 mm Hg change from grand baseline in same posture, SBP \< 90 mm Hg; DBP \>=20 mm Hg change from grand baseline in same posture, DBP\<50 mm Hg; 2), pulse rate (supine): \<40 or \> 120 bpm.

Supine SBP <90 mm Hg

Group	Value	95% CI
Placebo	1
PF-06291874 15 mg	0
PF-06291874 30 mg	0

Supine DBP <50 mm Hg

Group	Value	95% CI
Placebo	0
PF-06291874 15 mg	0
PF-06291874 30 mg	1

Supine pulse rate <40 bpm

Group	Value	95% CI
Placebo	0
PF-06291874 15 mg	0
PF-06291874 30 mg	0

Increase:supine SBP≥30 mm Hg

Group	Value	95% CI
Placebo	0
PF-06291874 15 mg	0
PF-06291874 30 mg	0

Decrease:supine SBP≥30 mm Hg

Group	Value	95% CI
Placebo	3
PF-06291874 15 mg	0
PF-06291874 30 mg	2

Decrease:supine DBP≥20 mm Hg

Group	Value	95% CI
Placebo	0
PF-06291874 15 mg	1
PF-06291874 30 mg	0

Supine pulse rate >120 bpm

Group	Value	95% CI
Placebo	0
PF-06291874 15 mg	1
PF-06291874 30 mg	0

Increase:supine DBP≥20 mm Hg

Group	Value	95% CI
Placebo	2
PF-06291874 15 mg	0
PF-06291874 30 mg	3

Number of Participants With Any Abnormal Laboratory Test Results - Part A Primary · Predose on Days 0,3,7,11 for all cohorts and 14 and 17 for Cohorts 1- 4A and 1B, and pre-dose on Days 21 and 28 for Cohorts 5A and 2B.

The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, MCV, MCH, MCHC, platelets, white blood cell count, absolute lymphocytes, absolute total neutrophils, absolute basophils, absolute eosinophils and absolute monocytes), coagulation (PPT, prothrombin), liver function(total bilirubin, AST, ALT, alkaline phosphatase, total protein and albumin), renal function (blood urea nitrogen, creatinine, uric acid), Lipids (cholesterol, HDL cholesterol, LDL cholesterol, triglycerides), Electrolytes (sodium, potassium, chloride, calcium, venous bicarbonate), clinical chemist

Group	Value	95% CI
Placebo	17
PF-06291874 5 mg	10
PF-06291874 15 mg	11
PF-06291874 50 mg	12
PF-06291874 100 mg	13
PF-06291874 150 mg	8

Number of Participants With Any Abnormal Laboratory Test Results - Part B Primary · Predose on Days 0,3,7,11 for all cohorts and 14 and 17 for Cohorts 1- 4A and 1B, and pre-dose on Days 21 and 28 for Cohorts 5A and 2B.

Group	Value	95% CI
PF-06291874 5 mg	8
PF-06291874 30 mg	12
Placebo	11

Single Dose Maximum Plasma Concentration (Cmax) for PF-06291874 - Part A Primary · 0 hour (pre-dose), 2, 4, 6, 8, 12, 19, 24 hours post-dose on Day 1

Cmax was maximum plasma concentration. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for pharmacokinetic (PK) analysis were collected at 0, 2, 4, 6, 8, 12, 19 and 24 hours post dose.

Group	Value	95% CI
PF-06291874 5 mg	137.0	± 17
PF-06291874 15 mg	427.1	± 22
PF-06291874 50 mg	1308	± 26
PF-06291874 100 mg	2582	± 19
PF-06291874 150 mg	3288	± 32

Single Dose Normalized Cmax (Cmax[dn]) for PF-06291874 - Part A Primary · 0 hour (pre-dose), 2, 4, 6, 8, 12, 19, 24 hours post-dose on Day 1

Cmax (dn) was dose normalized maximum plasma concentration. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for pharmacokinetic (PK) analysis were collected at 0, 2, 4, 6, 8, 12, 19 and 24 hours post dose.

Group	Value	95% CI
PF-06291874 5 mg	27.40	± 17
PF-06291874 15 mg	28.46	± 22
PF-06291874 50 mg	26.15	± 26
PF-06291874 100 mg	25.82	± 19
PF-06291874 150 mg	21.90	± 32

Single Dose Cmax for PF-06291874 - Part B Primary · 0 hour (pre-dose), 2, 4, 6, 8, 12, 19, 24 hours post-dose on Day 1

Cmax was maximum plasma concentration. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19 and 24 hours post dose.

Group	Value	95% CI
PF-06291874 15 mg	373.6	± 16
PF-06291874 30 mg	687.6	± 34

Single Dose Normalized Cmax (Cmax[dn]) for PF-06291874 - Part B Primary · 0 hour (pre-dose), 2, 4, 6, 8, 12, 19, 24 hours post-dose on Day 1

Cmax (dn) was dose normalized maximum plasma concentration. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19 and 24 hours post dose

Group	Value	95% CI
PF-06291874 15 mg	24.90	± 16
PF-06291874 30 mg	22.92	± 34

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: Placebo

Serious: 0/18 (0%)

Deaths: —

Part A: PF-06291874 5 mg

Serious: 0/12 (0%)

Deaths: —

Part A: PF-06291874 15 mg

Serious: 0/12 (0%)

Deaths: —

Part A: PF-06291874 50 mg

Serious: 0/12 (0%)

Deaths: —

Part A: PF-06291874 100 mg

Serious: 0/14 (0%)

Deaths: —

Part A: PF-06291874 150 mg

Serious: 0/12 (0%)

Deaths: —

Part B: Placebo

Serious: 0/13 (0%)

Deaths: —

Part B: PF-06291874 15 mg

Serious: 0/10 (0%)

Deaths: —

Part B: PF-06291874 30 mg

Serious: 0/14 (0%)

Deaths: —

Total

Serious: 0/117 (0%)

Deaths: —

Other adverse events (49 terms — click to expand)

Reaction	System	Part A: Placebo	Part A: PF-06291874 5 mg	Part A: PF-06291874 15 mg	Part A: PF-06291874 50 mg	Part A: PF-06291874 100 mg	Part A: PF-06291874 150 mg	Part B: Placebo	Part B: PF-06291874 15 mg	Part B: PF-06291874 30 mg	Total
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Dermatitis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Normochromic normocytic anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Otitis externa	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Excoriation	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Urinary hesitation	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—
Ecchymosis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Supraventricular extrasystoles	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Chromatopsia	Eye disorders	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Application site bruise	General disorders	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—
Vessel puncture site pain	General disorders	—	—	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT01856595 adverse events section.

Sponsor's own description

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of PF-06291874 in Type 2 Diabetes patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01856595 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 1 November 2018

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/NCT01856595.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01856595

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Diabetes Mellitus, Type 2

Other Pfizer trials

Verify against primary sources