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: February 20, 2013
Last verified: February 2013
  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
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: February 20, 2013
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
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014