A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug Given With Canagliflozin In Adults With Type 2 Diabetes Mellitus Taking Metformin

Back to Search
Print
Bookmark Trial

NCT02053116

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
DeLand, Florida, 32720, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

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
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with Type 2 Diabetes Mellitus and treated with metformin at a dose greater than or equal to 1000 mg for at least 3 months and are willing to switch to canagliflozin from metformin for the duration of the study

- Hemoglobin A1c of 7-10% at screening.

- Body Mass Index of at least 25 kg/m2.

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


- Compliant with study drug administration during the run-in period and throughout the
trial.


- Patients with fasting triglycerides greater than 500 mg/dL at screening.


- History of certain diabetic complications or cardiac problems.

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]

Call Now

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.

Advanced Search

Based on your search, you may also be interested in

Type 2 Diabetes MellitusErtugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
NCT04029480
  1. Napoli,
  2. Monterrey, Nuevo Leon
  3. Birmingham, Alabama
  4. Los Angeles, California
  5. Sacramento, California
  6. Hollywood, Florida
  7. Chicago, Illinois
  8. Baltimore, Maryland
  9. Royal Oak, Michigan
  10. Bronx, New York
  11. Philadelphia, Pennsylvania
  12. Mesquite, Texas
  13. Brussels, Bruxelles-Capitale, Region De
  14. London, Ontario
  15. Montreal, Quebec
  16. Barranquilla, Atlantico
  17. Bogota, Distrito Capital De Bogota
  18. San Jose,
  19. Santo Domingo, Distrito Nacional (Santo Domingo)
  20. Dijon, Cote-d'Or
  21. Chiquimula,
  22. Guatemala,
  23. Guatemala,
  24. Pecs, Baranya
  25. Gyula, Bekes
  26. Miskolc, Borsod-Abauj-Zemplen
  27. Nyiregyhaza, Szabolcs-Szatmar-Bereg
  28. Budapest,
  29. Budapest,
  30. Beer Sheva, HaDarom
  31. Haifa, Heifa
  32. Haifa, Heifa
  33. Ramat Gan, Tell Abib
  34. Jerusalem, Yerushalayim
  35. Firenze,
  36. Genova,
  37. Roma,
  38. Kubang Kerian, Kelantan
  39. Taiping, Perak
  40. Georgetown, Pulau Pinang
  41. Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
  42. Putrajaya, Wilayah Persekutuan Putrajaya
  43. Guadalajara, Jalisco
  44. Zapopan, Jalisco
  45. Madero, Tamaulipas
  46. Aguascalientes,
  47. Mexico City,
  48. Mexico,
  49. Queretaro,
  50. Davao, Davao Del Sur
  51. Marikina, Rizal
  52. Iloilo,
  53. Wierzchoslawice, Malopolskie
  54. Katowice, Slaskie
  55. Ufa, Baskortostan, Respublika
  56. Moscow, Moskva
  57. Novosibirsk, Novosibirskaya Oblast'
  58. Rostov-on-Don, Rostovskaya Oblast'
  59. Samara, Samarskaya Oblast'
  60. Saint Petersburg, Sankt-Peterburg
  61. Kazan, Tatarstan, Respublika
  62. Tomsk, Tomskaya Oblast'
  63. Voronezh, Voronezskaja Oblast'
  64. Al Ahsa, Ar Riyad
  65. Riyadh, Ar Riyad
  66. Riyadh, Ar Riyad
  67. Riyadh, Ar Riyad
  68. Riyadh, Ar Riyad
  69. Jeddah, Makkah Al Mukarramah
  70. Mecca, Makkah Al Mukarramah
  71. Adana,
  72. Istanbul,
  73. Chernivtsi, Chernivetska Oblast
  74. Dnipro, Dnipropetrovska Oblast
  75. Kharkiv, Kharkivska Oblast
  76. Kyiv, Kyivska Oblast
  77. Kyiv, Kyivska Oblast
  78. Odesa, Odeska Oblast
  79. Vinnytsia, Vinnytska Oblast
  80. Dubai, Dubayy
  81. Dubai, Dubayy
  82. Dubai, Dubayy
  83. Ajman,
  84. Ajman,
  85. London, London, City Of
  86. London, London, City Of
ALL GENDERS
10 Years+
years
MULTIPLE SITES
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
Advanced Information
Descriptive Information
Brief Title  ICMJE A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug Given With Canagliflozin In Adults With Type 2 Diabetes Mellitus Taking Metformin
Official Title  ICMJE A 6-week Phase 2a Randomized, Double-Blind, Placebo-Controlled Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral PF-05175157 Administered With Canagliflozin In Adult Subjects With Type 2 Diabetes Mellitus
Brief Summary A Phase 2a study to evaluate the effects of an investigational compound administered at 200 mg, twice daily (BID), for 6 weeks, with canagliflozin, in adult subjects with Type 2 Diabetes Mellitus (T2DM).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: PF-05175157
    Tablet, 200 mg, twice daily, 6 weeks
  • Drug: Placebo
    Tablet, 0 mg, twice daily, 2 weeks
Study Arms  ICMJE
  • Experimental: PF-05175157
    Intervention: Drug: PF-05175157
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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 Terminated
Actual Enrollment  ICMJE
 (submitted: May 16, 2014)		8
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2014)		60
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with Type 2 Diabetes Mellitus and treated with metformin at a dose greater than or equal to 1000 mg for at least 3 months and are willing to switch to canagliflozin from metformin for the duration of the study
  • Hemoglobin A1c of 7-10% at screening.
  • Body Mass Index of at least 25 kg/m2.

Exclusion Criteria:

  • Compliant with study drug administration during the run-in period and throughout the trial.
  • Patients with fasting triglycerides greater than 500 mg/dL at screening.
  • History of certain diabetic complications or cardiac problems.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02053116
Other Study ID Numbers  ICMJE B1731006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 May 2014

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