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Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01475461
First received: September 15, 2011
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Placebo
Drug: PF-04937319 - 3mg
Drug: PF-04937319 - 20mg
Drug: PF-04937319 - 50mg
Drug: PF-04937319 - 100mg
Drug: Sitagliptin - 100mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate Safety And Efficacy Of PF-04937319 And Sitagliptin On Glycemic Control In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • HbA1C - change from baseline [ Time Frame: 84-days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma glucose - change from baseline [ Time Frame: 84-days ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
  • Vitals - systolic blood pressure (SBP), diastolic blood pressue (DBP), heart rate [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
  • 12-lead electrocardiograms (ECGs) [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
  • Body weight [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
  • Clinical laboratory tests - hematology, chemistry, lipid profile, urinalysis [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]

Enrollment: 345
Study Start Date: November 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
double-dummy placebo tablets administered once-daily for 84-days
Experimental: PF-04937319 - Dose 1 Drug: PF-04937319 - 3mg
PF-04937319 3mg administered as tablets once-daily for 84-days
Experimental: PF-04937319 - Dose 2 Drug: PF-04937319 - 20mg
PF-04937319 20mg administered as tablets once-daily for 84-days
Experimental: PF-04937319 - Dose 3 Drug: PF-04937319 - 50mg
PF-04937319 50mg administered as tablets once-daily for 84-days
Experimental: PF-04937319 - Dose 4 Drug: PF-04937319 - 100mg
PF-04937319 100mg administered as tablets once-daily for 84-days
Active Comparator: Sitagliptin Drug: Sitagliptin - 100mg
Sitagliptin 100mg administered as tablets once-daily for 84-days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female

Exclusion Criteria:

  • patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory test results at screening
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475461

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
Pfizer Investigational Site
Los Angeles, California, United States, 90057
Pfizer Investigational Site
Spring Valley, California, United States, 91978
United States, Florida
Pfizer Investigational Site
Belleview, Florida, United States, 34420
Pfizer Investigational Site
Miami, Florida, United States, 33135
Pfizer Investigational Site
Ocala, Florida, United States, 34471
United States, Georgia
Pfizer Investigational Site
Conyers, Georgia, United States, 30094
United States, Idaho
Pfizer Investigational Site
Meridian, Idaho, United States, 83646
United States, Kentucky
Pfizer Investigational Site
Mount Sterling, Kentucky, United States, 40353
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89144
United States, New Jersey
Pfizer Investigational Site
Paramus, New Jersey, United States, 07652
United States, New York
Pfizer Investigational Site
Rochester, New York, United States, 14609
United States, North Dakota
Pfizer Investigational Site
Fargo, North Dakota, United States, 58103
United States, Ohio
Pfizer Investigational Site
Kettering, Ohio, United States, 45429
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29407
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78756
Pfizer Investigational Site
Houston, Texas, United States, 77081
Pfizer Investigational Site
Plano, Texas, United States, 75024
Pfizer Investigational Site
Sugar Land, Texas, United States, 77479
Pfizer Investigational Site
Tomball, Texas, United States, 77375
Hungary
Pfizer Investigational Site
Balatonfured, Hungary, 8230
Pfizer Investigational Site
Bekescsaba, Hungary, 5600
Pfizer Investigational Site
Budapest, Hungary, 1036
Pfizer Investigational Site
Debrecen, Hungary, 4043
Pfizer Investigational Site
Debrecen, Hungary, 4032
Pfizer Investigational Site
Gyor, Hungary, 9023
Pfizer Investigational Site
Polgar, Hungary, 4090
Pfizer Investigational Site
Szeged, Hungary, 6720
Pfizer Investigational Site
Zalaegerszeg, Hungary, 8900
India
Pfizer Investigational Site
Mumbai, Maharashtra, India, 400 012
Pfizer Investigational Site
Mumbai, Maharashtra, India, 400 007
Pfizer Investigational Site
Pune, Maharashtra, India, 411001
Pfizer Investigational Site
Jaipur, Rajasthan, India, 302001
Philippines
Pfizer Investigational Site
Cebu City, Philippines, 6000
Pfizer Investigational Site
Marikina City, Philippines, 1810
Pfizer Investigational Site
Pasig City, Philippines, 1605
Romania
Pfizer Investigational Site
Cluj-Napoca, Jud. Cluj, Romania, 400006
Pfizer Investigational Site
Bucuresti, Romania, 011234
Pfizer Investigational Site
Bucuresti, Romania, 020475
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia, 831 01
Pfizer Investigational Site
Bratislava, Slovakia, 851 01
Pfizer Investigational Site
Lucenec, Slovakia, 984 01
Pfizer Investigational Site
Nitra, Slovakia, 949 01
Pfizer Investigational Site
Nove Mesto nad Vahom, Slovakia, 915 01
Pfizer Investigational Site
Presov, Slovakia, 080 01
Pfizer Investigational Site
Trebisov, Slovakia, 075 01
Pfizer Investigational Site
Trencin, Slovakia, 911 01
South Africa
Pfizer Investigational Site
Bloemfontein, Free State, South Africa, 9301
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa, 1829
Pfizer Investigational Site
Midrand, Gauteng, South Africa, 1685
Pfizer Investigational Site
Pretoria, Gauteng, South Africa, 0083
Pfizer Investigational Site
Waverley, Gauteng, South Africa, 2090
Pfizer Investigational Site
Kimberley, Northern Cape, South Africa, 8301
Pfizer Investigational Site
Durban, South Africa, 4091
Pfizer Investigational Site
Moloto, South Africa, 1022
Taiwan
Pfizer Investigational Site
Changhua City, Taiwan, 500
Pfizer Investigational Site
New Taipei City, Taiwan, 220
Pfizer Investigational Site
Taichung, Taiwan, 40705
Pfizer Investigational Site
Tainan, Taiwan, 710
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01475461     History of Changes
Other Study ID Numbers: B1621007
Study First Received: September 15, 2011
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 2
type 2 diabetes mellitus
PF-04937319

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014