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

March 11, 2013 updated by: Pfizer

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
301

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Time Frame: Baseline, 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Time Frame: Baseline, Week 1, 2, 4, 8, 12
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
Time Frame: Baseline, Week 1, 2, 4, 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
Time Frame: 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% 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
Time Frame: Baseline, Week 1, 2, 4, 8, 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
Time Frame: Week 12
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
Time Frame: Week 12
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2611003

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