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Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01336738
First received: April 13, 2011
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

B2611002 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 5 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.


Condition Intervention Phase
Diabetes, Type 2
 Drug: Placebo
Drug: 150 mg PF-04991532
Drug: 450 mg PF-04991532
Drug: 750 mg PF-04991532
Drug: Sitagliptin 100 mg
 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: A 12-Week, Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging, Parallel Group Study To Evaluate The Efficacy And Safety Of Once Daily Pf-04991532 And Sitagliptin In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

Resource links provided by NLM:

U.S. FDA Resources

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:
  • Change from baseline in fasting plasma glucose (mg/dL) [ Time Frame: Up to Day 84 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving HbA1c <7%, as well as the proportion achieving <6.5% [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: Up to Day 84 ] [ Designated as safety issue: No ]
  • Clinical laboratory tests, 12 lead ECGs, vital signs, adverse events (AEs), as well as serious AEs (SAEs) and including episodes of hypoglycemic adverse events (HAEs) [ Time Frame: Up to Follow Up ] [ Designated as safety issue: Yes ]
  • Change from baseline in HbA1c [ Time Frame: Up to Day 84 ] [ Designated as safety issue: No ]
  • Proportion of subjects at Week 12 with body weight gain from baseline ≥1% [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  • Proportion of subjects at Week 12 with body weight loss from baseline ≥1% [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  • Proportion of subjects at Week 12 with body weight gain from baseline ≥2% [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  • Proportion of subjects at Week 12 with body weight loss from baseline ≥2%. [ Time Frame: Day 84 ] [ Designated as safety issue: No ]

Enrollment: 267
Study Start Date: June 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo for PF-04991532 and Sitagliptin
 Drug: Placebo
Tablets (n=6), 0 mg, once daily for 84 days
Experimental: 150 mg PF-04991532 Drug: 150 mg PF-04991532
Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days
Experimental: 450 mg PF-04991532 Drug: 450 mg PF-04991532
Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days
Experimental: 750 mg PF-04991532 Drug: 750 mg PF-04991532
Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days
Active Comparator: Sitagliptin 100 mg Drug: Sitagliptin 100 mg
Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days

  Eligibility

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

Inclusion Criteria:

Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2

Exclusion Criteria:

Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336738

  Show 44 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01336738     History of Changes
Other Study ID Numbers: B2611002
Study First Received: April 13, 2011
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 2
safety and efficacy study with PF-04991532
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 May 21, 2013