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
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, 91730, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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 180 mmHg (systolic) or greater than or
equal to 105 mmHg (diastolic)


- Clinically relevant ECG abnormalities


- Positive urine drug test

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Type 2 Diabetes MellitusA Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus
NCT02211261
  1. Chula Vista, California
  2. Chula Vista, California
  3. DeLand, Florida
  4. Orlando, Florida
  5. South Miami, Florida
  6. South Miami, Florida
  7. High Point, North Carolina
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Type 2 Diabetes MellitusEffect of PF-00734200 in Subjects With Type 2 Diabetes
NCT00618007
  1. Birmingham, Alabama
  2. Chandler, Arizona
  3. Litchfield Park, Arizona
  4. Phoenix, Arizona
  5. Artesia, California
  6. Cerritos, California
  7. Fresno, California
  8. Greenbrea, California
  9. Huntington Beach, California
  10. Los Angeles, California
  11. National City, California
  12. Roseville, California
  13. Valley Village, California
  14. West Covina, California
  15. DeFuniak Springs, Florida
  16. Jacksonville, Florida
  17. Miami, Florida
  18. Miami, Florida
  19. New Port Richey, Florida
  20. Ocala, Florida
  21. Pinecrest, Florida
  22. St. Petersburg, Florida
  23. Conyers, Georgia
  24. Idaho Falls, Idaho
  25. Indianapolis, Indiana
  26. Wichita, Kansas
  27. Lexington, Kentucky
  28. Madisonville, Kentucky
  29. Scarborough, Maine
  30. Baltimore, Maryland
  31. Oxon Hill, Maryland
  32. Ann Arbor, Michigan
  33. Bay City, Michigan
  34. Canton, Michigan
  35. Troy, Michigan
  36. Jackson, Mississippi
  37. Picayune, Mississippi
  38. St. Louis, Missouri
  39. St. Louis, Missouri
  40. St. Peters, Missouri
  41. Las Vegas, Nevada
  42. Elizabeth, New Jersey
  43. Trenton, New Jersey
  44. Albuquerque, New Mexico
  45. Syracuse, New York
  46. Winston-Salem, North Carolina
  47. Marion, Ohio
  48. Eugene, Oregon
  49. Cumberland, Rhode Island
  50. Aiken, South Carolina
  51. Florence, South Carolina
  52. Kingsport, Tennessee
  53. Dallas, Texas
  54. Dallas, Texas
  55. El Paso, Texas
  56. Houston, Texas
  57. Houston, Texas
  58. Hurst, Texas
  59. Odessa, Texas
  60. Pearland, Texas
  61. San Antonio, Texas
  62. Salt Lake City, Utah
  63. Bennington, Vermont
  64. Ettrick, Virginia
  65. Richmond, Virginia
  66. Virginia Beach, Virginia
  67. Virginia Beach, Virginia
  68. Spokane, Washington
  69. Kenosha, Wisconsin
  70. Coquitlam, British Columbia
  71. Toronto, Ontario
  72. Laval, Quebec
  73. Pointe-Claire, Quebec
  74. Quebec,
  75. Seoul,
  76. Seoul,
  77. Seoul,
  78. Seoul,
  79. San Juan,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Type 2 Diabetes MellitusThis Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus
NCT00418522
  1. Phoenix, Arizona
  2. Tucson, Arizona
  3. Concord, California
  4. Encino, California
  5. Fresno, California
  6. Fullerton, California
  7. Long Beach, California
  8. Mission Viejo, California
  9. Pasadena, California
  10. San Diego, California
  11. San Diego, California
  12. San Luis Obispo, California
  13. Spring Valley, California
  14. Stockton, California
  15. Walnut Creek, California
  16. West Hills, California
  17. Golden, Colorado
  18. Waterbury, Connecticut
  19. Newark, Delaware
  20. Chiefland, Florida
  21. Clearwater, Florida
  22. Hollywood, Florida
  23. Kissimmee, Florida
  24. Miami, Florida
  25. Ocala, Florida
  26. Saint Cloud, Florida
  27. Winter Park, Florida
  28. Atlanta, Georgia
  29. Lawrenceville, Georgia
  30. Lawrenceville, Georgia
  31. Woodstock, Georgia
  32. Boise, Idaho
  33. Hayden Lake, Idaho
  34. Indianapolis, Indiana
  35. Overland Park, Kansas
  36. Topeka, Kansas
  37. Lexington, Kentucky
  38. Louisville, Kentucky
  39. Baton Rouge, Louisiana
  40. New Orleans, Louisiana
  41. Haverhill, Massachusetts
  42. Springfield, Missouri
  43. Omaha, Nebraska
  44. Las Vegas, Nevada
  45. Staten Island, New York
  46. Charlotte, North Carolina
  47. Statesville, North Carolina
  48. Winston-Salem, North Carolina
  49. Kettering, Ohio
  50. Maumee, Ohio
  51. Toledo, Ohio
  52. Oklahoma City, Oklahoma
  53. Medford, Oregon
  54. Melrose Park, Pennsylvania
  55. Greenville, South Carolina
  56. Greer, South Carolina
  57. Spartanburg, South Carolina
  58. Milan, Tennessee
  59. Arlington, Texas
  60. Beaumont, Texas
  61. Dallas, Texas
  62. Dallas, Texas
  63. Dallas, Texas
  64. El Paso, Texas
  65. Houston, Texas
  66. Houston, Texas
  67. San Antonio, Texas
  68. San Antonio, Texas
  69. Bennington, Vermont
  70. Richmond, Virginia
  71. Federal Way, Washington
  72. Menomonee Falls, Wisconsin
  73. Carolina,
ALL GENDERS
30 Years+
years
MULTIPLE SITES
Type 2 Diabetes MellitusSix Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes
NCT00424411
  1. Burlingame, California
  2. Irvine, California
  3. Los Angeles, California
  4. Newport Beach, California
  5. Orange, California
  6. San Diego, California
  7. San Francisco, California
  8. Tustin, California
  9. New Haven, Connecticut
  10. Washington, District of Columbia
  11. Clearwater, Florida
  12. Miami, Florida
  13. Tampa, Florida
  14. Chicago, Illinois
  15. Louisville, Kentucky
  16. New Orleans, Louisiana
  17. Columbia, Missouri
  18. St Louis, Missouri
  19. St. Louis, Missouri
  20. Omaha, Nebraska
  21. New Hyde Park, New York
  22. New York, New York
  23. Rochester, New York
  24. Durham, North Carolina
  25. Greenville, North Carolina
  26. Winston-salem, North Carolina
  27. Cleveland, Ohio
  28. Portland, Oregon
  29. Austin, Texas
  30. Dallas, Texas
  31. Irving, Texas
  32. San Antonio, Texas
  33. Burlington, Vermont
  34. Charlottesville, Virginia
  35. Renton, Washington
  36. Calgary, Alberta
  37. Edmonton, Alberta
  38. Red Deer, Alberta
  39. Winnipeg, Manitoba
  40. St John's, Newfoundland and Labrador
  41. Halifax, Nova Scotia
  42. Mississauga, Ontario
  43. Ottawa, Ontario
  44. Toronto, Ontario
  45. Chomedy, Quebec
  46. Montreal, Quebec
ALL GENDERS
35 Years+
years
MULTIPLE SITES
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 9, 2021
Estimated Primary Completion Date July 6, 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 180 mmHg (systolic) or greater than or equal to 105 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 Canada,   Hungary,   Korea, Republic of,   Poland,   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 June 2020

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