Study Of Safety And Efficacy Of PF-04971729 In Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01059825
First received: January 29, 2010
Last updated: November 12, 2012
Last verified: November 2012
  Purpose

B1521006 is designed to study how safe and how effective is an investigational drug (PF-04971729) in people with diabetes. Patients in the study will receive 1 of 6 treatments for 3-months including 1 treatment with an approved drug - sitagliptin.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: 1 mg PF-04971729
Drug: 5 mg PF-04971729
Drug: 10 mg PF-04971729
Drug: 25 mg PF-04971729
Drug: 100 mg sitagliptin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy Of Once Daily PF-04971729 And Sitagliptin On Glycemic Control And Body Weight 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:
  • Placebo-adjusted, change from baseline in HbA1C (%) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Placebo-adjusted, percent change from baseline in body weight [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  • Placebo-adjusted change from baseline in systolic and diastolic blood pressure over time [ Time Frame: Up to Day 84 ] [ Designated as safety issue: No ]
  • Placebo-adjusted change from baseline in fasting plasma glucose [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving HbA1C <7% as well as <6.5% [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  • Clinical laboratory tests, 12-lead ECG, vital signs, AEs including genital-urinary tract infections and hypoglycemic episodes [ Time Frame: Up to follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 328
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo for PF-04971729 and sitagliptin
Drug: Placebo
Tablets (n=4), 0mg, once daily x 84 days
Experimental: 1 mg PF-04971729 Drug: 1 mg PF-04971729
Tablets (n=1), 1 mg strength + tablets (n=3), 0 mg, all once daily x 84 days
Experimental: 5 mg PF-04971729 Drug: 5 mg PF-04971729
Tablet (n=1), 5mg strength + tablets (n=3), 0 mg, all once daily x 84 days
Experimental: 10 mg PF-04971729 Drug: 10 mg PF-04971729
Tablets (n=2), 5 mg strength + tablets (n=2), 0 mg, all once daily x 84 days
Experimental: 25 mg PF-04971729 Drug: 25 mg PF-04971729
Tablet (n=1), 25 mg strength + tablets (n=3), 0 mg, all once daily x 84 days
Active Comparator: 100 mg sitagliptin Drug: 100 mg sitagliptin
Tablet (n=1), 100mg strength + tablets (n=3), 0 mg, all once daily x 84 days

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes on stable doses of background medicines for management of the diabetes; aged 18-70 years; body mass index between 23-45 kg/m2

Exclusion Criteria:

  • Patients with type 1 diabetes, heart attack or stroke in last 6-months, uncontrolled blood pressure, significant kidney disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059825

  Show 46 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: NCT01059825     History of Changes
Other Study ID Numbers: B1521006
Study First Received: January 29, 2010
Last Updated: November 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 2
safety and efficacy study with PF-04971729
Type 2 diabetes

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 17, 2014