Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03985293
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : September 18, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
4 matching placebo tablets taken twice a day (BID)
Experimental: PF-06882961 2.5 milligrams (mg) 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.
Experimental: PF-06882961 10 mg 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.
Experimental: PF-06882961 40 mg
Participants will be titrated up to 2 weeks to reach desired dose level
 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.
Experimental: PF-06882961 80 mg
Participants will be titrated up to 4 weeks to reach desired dose level
 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.
Experimental: PF-06882961 120 mg
Participants will be titrated up to 6 weeks to reach desired dose level
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16 [ Time Frame: Baseline, Week 16 ]

Secondary Outcome Measures :
  1. Percentage of Participants Achieving Less Than (<) 7% Glycosylated Hemoglobin (HbA1c) Levels [ Time Frame: Baseline, Week 16 ]
  2. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 2 [ Time Frame: Baseline, Week 2 ]
  3. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 4 [ Time Frame: Baseline, Week 4 ]
  4. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 6 [ Time Frame: Baseline, Week 6 ]
  5. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 8 [ Time Frame: Baseline, Week 8 ]
  6. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 [ Time Frame: Baseline, Week 12 ]
  7. Change from baseline in fasting plasma glucose at week 2 [ Time Frame: Baseline, week 2 ]
  8. Change from baseline in fasting plasma glucose at week 4 [ Time Frame: Baseline, week 4 ]
  9. Change from baseline in fasting plasma glucose at week 6 [ Time Frame: Baseline, week 6 ]
  10. Change from baseline in fasting plasma glucose at week 8 [ Time Frame: Baseline, week 8 ]
  11. Change from baseline in fasting plasma glucose at week 12 [ Time Frame: Baseline, week 12 ]
  12. Change from baseline in fasting plasma glucose at week 16 [ Time Frame: Baseline, week 16 ]
  13. Change from baseline in body weight at week 2 [ Time Frame: Baseline, week 2 ]
  14. Change from baseline in body weight at week 4 [ Time Frame: Baseline, week 4 ]
  15. Change from baseline in body weight at week 6 [ Time Frame: Baseline, week 6 ]
  16. Change from baseline in body weight at week 8 [ Time Frame: Baseline, week 8 ]
  17. Change from baseline in body weight at week 12 [ Time Frame: Baseline, week 12 ]
  18. Change from baseline in body weight at week 16 [ Time Frame: Baseline, week 16 ]
  19. Incidence of treatment emergent adverse events (AEs and SAEs) [ Time Frame: Baseline up to week 21 ]
  20. Incidence of treatment emergent clinical laboratory abnormalities [ Time Frame: Baseline through week 21 ]
  21. Incidence of treatment emergent vital signs abnormalities [ Time Frame: Baseline through week 21 ]
  22. Incidence of treatment emergent ECG abnormalities [ Time Frame: Baseline through week 21 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03985293


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 103 study locations
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03985293    
Other Study ID Numbers: C3421005
2019-000218-12 ( EudraCT Number )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases