Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes

A 12-week, Phase 2, Randomized, Double-blind, Placebo Controlled, Dose-ranging, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Pf-04991532 and Once Daily Sitagliptin in Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

B2611003 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 6 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 Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: 25 mg PF-04991532; Drug: 75 mg PF-04991532; Drug: 150 mg PF-04991532; Drug: 300 mg PF-04991532; Drug: Sitagliptin 100 mg

• Study Type: Interventional
• Enrollment (Actual): 301
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G3K 2P8
    • Pfizer Investigational Site
  • British Columbia
    • Surrey, British Columbia, Canada, V4A 2H9
      • Pfizer Investigational Site
  • Newfoundland and Labrador
    • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
      • Pfizer Investigational Site
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Pfizer Investigational Site
    • Mississauga, Ontario, Canada, L4Y 2N8
      • Pfizer Investigational Site
  • Quebec
    • Mirabel, Quebec, Canada, J7J 2K8
      • Pfizer Investigational Site
• Hungary
  • Balatonfured, Hungary, 8230
    • Pfizer Investigational Site
  • Kistelek, Hungary, 6760
    • Pfizer Investigational Site
• Mexico
  • Aguascalientes, Mexico, 20234
    • Pfizer Investigational Site
  • DF
    • Mexico, DF, Mexico, 06700
      • Pfizer Investigational Site
  • Estado de Mexico
    • Tlalnepantla, Estado de Mexico, Mexico, 54055
      • Pfizer Investigational Site
• Slovakia
  • Bratislava, Slovakia, 851 01
    • Pfizer Investigational Site
  • Nove Mesto nad Vahom, Slovakia, 915 01
    • Pfizer Investigational Site
  • Pezinok, Slovakia, 902 01
    • Pfizer Investigational Site
  • Presov, Slovakia, 080 01
    • Pfizer Investigational Site
• Taiwan
  • Taichung, Taiwan, 40705
    • Pfizer Investigational Site
  • Taoyuan County, Taiwan, 333
    • Pfizer Investigational Site
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Pfizer Investigational Site
  • California
    • Roseville, California, United States, 95661
      • Pfizer Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80209
      • Pfizer Investigational Site
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Pfizer Investigational Site
    • Ocala, Florida, United States, 34471
      • Pfizer Investigational Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Pfizer Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Pfizer Investigational Site
  • Kansas
    • Augusta, Kansas, United States, 67010
      • Pfizer Investigational Site
    • Overland Park, Kansas, United States, 66215
      • Pfizer Investigational Site
    • Wichita, Kansas, United States, 67207
      • Pfizer Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Pfizer Investigational Site
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Pfizer Investigational Site
  • Maine
    • Auburn, Maine, United States, 04210
      • Pfizer Investigational Site
  • Minnesota
    • Brooklyn Center, Minnesota, United States, 55430
      • Pfizer Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89101
      • Pfizer Investigational Site
  • New Jersey
    • Trenton, New Jersey, United States, 08611
      • Pfizer Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Pfizer Investigational Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Pfizer Investigational Site
  • Pennsylvania
    • Lansdale, Pennsylvania, United States, 19446
      • Pfizer Investigational Site
  • Texas
    • Dallas, Texas, United States, 75246
      • Pfizer Investigational Site
    • Katy, Texas, United States, 77450
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78229
      • Pfizer Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Pfizer Investigational Site
    • Richmond, Virginia, United States, 23294
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 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

6

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=3) 0 mg once daily in the morning for 84 days; and tablets (n=4) 0 mg once daily in the evening for 84 days.
Placebo Comparator: Placebo; Placebo for PF-04991532 and sitagliptin	Drug: Placebo; Tablets (n=4), 0 mg twice daily for 84 days
Experimental: 25 mg PF-04991532	Drug: 25 mg PF-04991532; Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days
Experimental: 75 mg PF-04991532	Drug: 75 mg PF-04991532; Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days
Experimental: 150 mg PF-04991532	Drug: 150 mg PF-04991532; Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days
Experimental: 300 mg PF-04991532	Drug: 300 mg PF-04991532; Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice 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
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
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 With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline	Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% gain in body weight from baseline signifies a higher risk of diabetes.	Week 12
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight 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% loss in body weight 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 18, 2011
• First Posted (Estimate): April 20, 2011

Study Record Updates

• Last Update Posted (Estimate): April 23, 2013
• Last Update Submitted That Met QC Criteria: March 11, 2013
• Last Verified: March 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: B2611003