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

  Show 60 Study Locations
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014