A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus

NCT03985293

Last updated date
Study Location
Catalina Research Institute, LLC
Montclair, California, 91763, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with T2DM who are treated with metformin and/or diet and exercise

- HbA1c greater than or equal to 7% and less than or equal to 10.5%

- Total body weight >50 kg (110 lb) with BMI 24.5 to 45.4 kg/m^2

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Any condition possibly affecting drug absorption


- Diagnosis of Type 1 diabetes


- History of myocardial infarction, unstable angina, arterial revascularization, stroke,
heart failure, or transient ischemic attack within 6 months of screening


- Any malignancy not considered cured


- Personal or family history of MTC or MEN2, or participants with suspected MTC


- Acute pancreatitis or history of chronic pancreatitis


- Symptomatic gallbladder disease


- Known medical history of active proliferative retinopathy and/or macular edema


- Known medical history of active liver disease, including chronic active hepatitis B or
C, or primary biliary cirrhosis


- Known history of HIV


- Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or
equal to 100 mmHg (diastolic)


- Clinically relevant ECG abnormalities


- Positive urine drug test

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Advanced Information
Descriptive Information
Brief Title  ICMJE A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus
Official Title  ICMJE A 16-WEEK, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TWICE DAILY PF-06882961 ADMINISTRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED ON METFORMIN OR DIET AND EXERCISE
Brief Summary This multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise. In addition, the study is intended to enable selection of efficacious doses for future clinical development of PF-06882961.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Placebo
    4 matching placebo tablets taken twice a day (BID)
  • Drug: PF-06882961
    Participants will be randomized to one of 5 active doses (2.5, 10, 40, 80, or 120 mg), taking 4 tablets twice daily for 16 weeks.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06882961 2.5 milligrams (mg)
    Intervention: Drug: PF-06882961
  • Experimental: PF-06882961 10 mg
    Intervention: Drug: PF-06882961
  • Experimental: PF-06882961 40 mg
    Participants will be titrated up to 2 weeks to reach desired dose level
    Intervention: Drug: PF-06882961
  • Experimental: PF-06882961 80 mg
    Participants will be titrated up to 4 weeks to reach desired dose level
    Intervention: Drug: PF-06882961
  • Experimental: PF-06882961 120 mg
    Participants will be titrated up to 6 weeks to reach desired dose level
    Intervention: Drug: PF-06882961
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 22, 2021
Estimated Primary Completion Date July 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with T2DM who are treated with metformin and/or diet and exercise
  • HbA1c greater than or equal to 7% and less than or equal to 10.5%
  • Total body weight >50 kg (110 lb) with BMI 24.5 to 45.4 kg/m^2

Exclusion Criteria:

  • Any condition possibly affecting drug absorption
  • Diagnosis of Type 1 diabetes
  • History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening
  • Any malignancy not considered cured
  • Personal or family history of MTC or MEN2, or participants with suspected MTC
  • Acute pancreatitis or history of chronic pancreatitis
  • Symptomatic gallbladder disease
  • Known medical history of active proliferative retinopathy and/or macular edema
  • Known medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis
  • Known history of HIV
  • Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
  • Clinically relevant ECG abnormalities
  • Positive urine drug test
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Bulgaria,   Canada,   Hungary,   Korea, Republic of,   Poland,   Slovakia,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03985293
Other Study ID Numbers  ICMJE C3421005
2019-000218-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP