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4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03538743
Recruitment Status : Completed
First Posted : May 29, 2018
Results First Posted : July 1, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants will receive an investigational product or placebo for 28 days.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Placebo Drug: PF-06882961 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ESCALATING ORAL DOSES OF PF-06882961 IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS
Actual Study Start Date : June 25, 2018
Actual Primary Completion Date : May 23, 2019
Actual Study Completion Date : June 10, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Tablet, 0 mg, twice daily, 28 days
Experimental: PF-06882961 30 mg Drug: PF-06882961
Tablet, 15 mg twice daily, 28 days
Experimental: PF-06882961 100 mg Drug: PF-06882961
Tablet, 50 mg twice daily, 28 days
Experimental: PF-06882961 300 mg Drug: PF-06882961
Tablet, 150 mg twice daily, 28 days
Experimental: PF-06882961 600 mg Drug: PF-06882961
Tablet, 300 mg twice daily, 28 days
Experimental: PF-06882961 dose TBD Cohort 5 Drug: PF-06882961
Tablet, dose TBD, twice daily, Cohort 5, 28 days
Experimental: PF-06882961 dose TBD Cohort 6 Drug: PF-06882961
Tablet, dose TBD, twice daily, Cohort 6, 28 days
Experimental: PF-06882961 dose TBD Cohort 7 Drug: PF-06882961
Tablet, dose TBD, twice daily, Cohort 7, 28 days
Experimental: PF-06882961 dose TBD Cohort 8 Drug: PF-06882961
Tablet, dose TBD, twice daily, Cohort 8, 28 days


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From baseline to up to 35 days after last dose for a total of approximately 63 days ]
    Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.

  2. Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality [ Time Frame: From baseline to up to 14 days after last dose for a total of approximately 42 days ]
    Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin).

  3. Number of Participants With Abnormal Vital Signs [ Time Frame: From baseline to up to 14 days after last dose for a total of approximately 42 days ]
    Vital signs categorical summarization criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP >= 20 mmHg.

  4. Number of Participants With Abnormal Electrocardiogram (ECG) Interval [ Time Frame: From baseline to up to 14 days after last dose for a total of approximately 42 days ]

    ECG categorical summarization criteria: 1. PR interval (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): a) greater than or equal to (>=) 300 millisecond (msec), b) >=25% increase when baseline is > 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec.

    2. QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) >=140 msec, b) >=50% increase from baseline.

    3. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and <=480 msec, b) >480 msec and <=500 msec, c) >500 msec, d) >30 msec and <=60 msec increase from baseline, e) >60 msec increase from baseline



Secondary Outcome Measures :
  1. AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 [ Time Frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28 ]
    Area under the concentration-time profile from time zero to time 24 hours (AUC24) was calculated as AUCtau1 +AUCtau2, where AUCtau was area under the plasma concentration-time profile from time zero to time tau (tau1 = 0 to 10 hours and tau2=10 to 24 hours). AUCtau was determined using linear/log trapezoidal method.

  2. Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 [ Time Frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 28 ]

    For BID dosing, parameters were calculated for both dosing intervals (0-10 hr = interval 1 and 10-24 hr = interval 2) and were displayed as Cmax1, Cmax2.

    Cmax1: maximum plasma concentration during the dosing interval τ1 =0 to 10 hours.

    Cmax2: maximum plasma concentration during the dosing interval τ2=10 to 24 hours.


  3. Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 [ Time Frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28 ]
    Time for Cmax, Cmax1 and Cmax2 (Tmax, Tmax1 and Tmax2) of PF-06293620 was observed directly from data as time of first occurrence.

  4. Terminal Half-life (t½) of PF-06882961 on Day 28 [ Time Frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  5. Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28 [ Time Frame: 0 to 24 hours post-dose on Day 28 ]
    Ae was the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval was 24 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL was the approximate specific gravity of urine.

  6. Ae24 (%) of PF-06882961 on Day 28 [ Time Frame: 0 to 24 hours post-dose on Day 28 ]
    Percent of dose recovered in urine as unchanged drug. Ae24% = 100* Ae24/Dose

  7. Renal Clearance (CLr) of PF-06882961 on Day 28 [ Time Frame: 0 to 24 hours post-dose on Day 28 ]
    CLr was calculated as Ae divided by AUCtau, where dosing interval is 24 hours.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes treated with a stable dose of metformin at least 500 mg
  • HbA1c value between 7.0 and 10.5%

Exclusion Criteria:

- Type 1 diabetes or secondary forms of diabetes

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538743


Locations
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United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
United States, Florida
Qps-Mra, Llc
South Miami, Florida, United States, 33143
Qps-Mra,Llc
South Miami, Florida, United States, 33143
United States, Kansas
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] March 22, 2018
Statistical Analysis Plan  [PDF] June 19, 2019

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03538743    
Other Study ID Numbers: C3421002
First Posted: May 29, 2018    Key Record Dates
Results First Posted: July 1, 2020
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Type 2 diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases