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
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: 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, Type 2
Diabetes Mellitus
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 16, 2014