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: June 5, 2013
Last verified: June 2013
  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:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 [ Time Frame: Baseline, Week 1, 2, 4, 8 ] [ Designated as safety issue: No ]
    HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.

  • Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.

  • Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
    Overweight or obesity increases the risk for developing diabetes. The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c.

  • Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% body weight gain from baseline signifies a higher risk of diabetes.

  • Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c. Participants with >= 1% or >= 2% body weight loss from baseline signifies an improvement of glycemia.


Enrollment: 266
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
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: NCT01336738

  Hide Study Locations
Locations
United States, Arkansas
Pfizer Investigational Site
Jonesboro, Arkansas, United States, 72404
Pfizer Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90057
Pfizer Investigational Site
Palm Springs, California, United States, 92262
United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
Melbourne, Florida, United States, 32901
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
Pfizer Investigational Site
Conyers, Georgia, United States, 30094
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60607
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40213
United States, Massachusetts
Pfizer Investigational Site
Fall River, Massachusetts, United States, 02720
United States, New York
Pfizer Investigational Site
Brooklyn, New York, United States, 11230
United States, North Carolina
Pfizer Investigational Site
Cary, North Carolina, United States, 27518
Pfizer Investigational Site
Wilmington, North Carolina, United States, 28401
United States, Ohio
Pfizer Investigational Site
Columbus, Ohio, United States, 43213
United States, Rhode Island
Pfizer Investigational Site
East Providence, Rhode Island, United States, 02915
Pfizer Investigational Site
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Pfizer Investigational Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Pfizer Investigational Site
Bristol, Tennessee, United States, 37620
Pfizer Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
Houston, Texas, United States, 77081
Pfizer Investigational Site
Houston, Texas, United States, 77036
Pfizer Investigational Site
Houston, Texas, United States, 77074
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22911
United States, Wisconsin
Pfizer Investigational Site
Kenosha, Wisconsin, United States, 53142
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53209
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Pfizer Investigational Site
Strathroy, Ontario, Canada, N7G 1Y7
Pfizer Investigational Site
Thornhill, Ontario, Canada, L4J 8L7
Pfizer Investigational Site
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
Pfizer Investigational Site
Laval, Quebec, Canada, H7T 2P5
Pfizer Investigational Site
St-Romuald, Quebec, Canada, G6W 5M6
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1036
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Mexico
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44130
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44650
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64460
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia, 831 01
Taiwan
Pfizer Investigational Site
Tainan, Taiwan, 710
Pfizer Investigational Site
Taipei, Taiwan, 100
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: NCT01336738     History of Changes
Other Study ID Numbers: B2611002
Study First Received: April 13, 2011
Results First Received: June 5, 2013
Last Updated: June 5, 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 July 20, 2014