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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: 150 mg PF-04991532; Drug: 450 mg PF-04991532; Drug: 750 mg PF-04991532; Drug: Sitagliptin 100 mg

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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
Placebo Comparator: Placebo; Matching placebo for PF-04991532 and Sitagliptin	Drug: Placebo; Tablets (n=6), 0 mg, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12	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.	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12		Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8	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.	Baseline, Week 1, 2, 4, 8
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12	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.	Baseline, Week 1, 2, 4, 8, 12
Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels	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.	Week 12
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline	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.	Week 12
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline	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.	Week 12

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: April 13, 2011
• First Submitted That Met QC Criteria: April 14, 2011
• First Posted (Estimate): April 18, 2011

Study Record Updates

• Last Update Posted (Estimate): August 6, 2013
• Last Update Submitted That Met QC Criteria: June 5, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Phase 2; safety and efficacy study with PF-04991532
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Micronutrients; Vitamins; Incretins; Vitamin B Complex; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate; Nicotinic Acids; 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid
• Other Study ID Numbers: B2611002