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

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ClinicalTrials.gov Identifier: NCT03985293
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

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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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 6, 2020
Estimated Study Completion Date : November 3, 2020

Resource links provided by the National Library of Medicine


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.




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 ]


Information from the National Library of Medicine

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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 180 mmHg (systolic) or greater than or equal to 105 mmHg (diastolic)
  • Clinically relevant ECG abnormalities
  • Positive urine drug test

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
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, California
Diablo Clinical Research Incorporated Not yet recruiting
Walnut Creek, California, United States, 94598
United States, Florida
NewPhase Clinical Trials, Corp. Not yet recruiting
Miami Beach, Florida, United States, 33140
Sunshine Research Center, Inc Not yet recruiting
Opa-locka, Florida, United States, 33054
Andres Patron D.O. P.A. Not yet recruiting
Pembroke Pines, Florida, United States, 33026
United States, Georgia
Ellipsis Group Not yet recruiting
Atlanta, Georgia, United States, 30342
United States, New Jersey
Premier Research Not yet recruiting
Trenton, New Jersey, United States, 08611
United States, North Carolina
PharmQuest Not yet recruiting
Greensboro, North Carolina, United States, 27408
United States, Texas
Dallas Diabetes Research Center Not yet recruiting
Dallas, Texas, United States, 75230
Canada, Ontario
Aggarwal and Associates Limited Not yet recruiting
Brampton, Ontario, Canada, L6T 0G1
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03985293     History of Changes
Other Study ID Numbers: C3421005
2019-000218-12 ( EudraCT Number )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases