A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics

Back to Search
Print
Bookmark Trial

NCT00886821

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Cetero Research
Miami Gardens, Florida, 33169, 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
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and/or female patients (females will be women of non-childbearing potential) with an historical diagnosis of type 2 diabetes mellitus, who are currently being treated with metformin at a dose at or near maximum.

- Hb A1c between 7-10%.

- Fasting C-peptide >0.4 nmol/L.

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


- History of clinically significant chronic conditions other than T2DM not well
controlled by either diet or medications.


- Patients with pancreatitis or considered a high risk for pancreatitis.


- History of contraindications to metformin therapy.


- Previous treatment with an approved or investigational GLP 1 mimetic.

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. Wierzchoslawice, Malopolskie
  2. Katowice, Slaskie
  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. Ufa, Baskortostan, Respublika
  54. Moscow, Moskva
  55. Novosibirsk, Novosibirskaya Oblast'
  56. Rostov-on-Don, Rostovskaya Oblast'
  57. Samara, Samarskaya Oblast'
  58. Saint Petersburg, Sankt-Peterburg
  59. Kazan, Tatarstan, Respublika
  60. Tomsk, Tomskaya Oblast'
  61. Voronezh, Voronezskaja Oblast'
  62. Al Ahsa, Ar Riyad
  63. Riyadh, Ar Riyad
  64. Riyadh, Ar Riyad
  65. Riyadh, Ar Riyad
  66. Riyadh, Ar Riyad
  67. Jeddah, Makkah Al Mukarramah
  68. Mecca, Makkah Al Mukarramah
  69. Adana,
  70. Istanbul,
  71. Chernivtsi, Chernivetska Oblast
  72. Kharkiv, Kharkivska Oblast
  73. Kyiv, Kyivska Oblast
  74. Kyiv, Kyivska Oblast
  75. Odesa, Odeska Oblast
  76. Vinnytsia, Vinnytska Oblast
  77. Dubai, Dubayy
  78. Dubai, Dubayy
  79. Dubai, Dubayy
  80. Ajman,
  81. Ajman,
  82. London, London, City Of
  83. 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 Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics
Official Title  ICMJE A Phase 1, Placebo-controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Escalating Subcutaneous Doses Of Cvx-096 In Type 2 Diabetic Adult Subjects
Brief Summary The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE Biological: CVX-096
Subcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg
Study Arms  ICMJE Experimental: 1
Intervention: Biological: CVX-096
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2010)		114
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2009)		48
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and/or female patients (females will be women of non-childbearing potential) with an historical diagnosis of type 2 diabetes mellitus, who are currently being treated with metformin at a dose at or near maximum.
  • Hb A1c between 7-10%.
  • Fasting C-peptide >0.4 nmol/L.

Exclusion Criteria:

  • History of clinically significant chronic conditions other than T2DM not well controlled by either diet or medications.
  • Patients with pancreatitis or considered a high risk for pancreatitis.
  • History of contraindications to metformin therapy.
  • Previous treatment with an approved or investigational GLP 1 mimetic.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 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 NCT00886821
Other Study ID Numbers  ICMJE B1111001
CVX-096-101 ( Other Identifier: Alias Study Number )
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 March 2017

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