MedDataX Logo

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

NCT ID: NCT01338870

Last Updated: 2013-04-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01336738

Diabetes, Type 2
COMPLETED PHASE2

Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes

NCT01475461

Type 2 Diabetes Mellitus
COMPLETED PHASE2

Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes

NCT01933672

Type 2 Diabetes Mellitus
COMPLETED PHASE1

A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)

NCT01076075

Type 2 Diabetes Mellitus
COMPLETED PHASE3

Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus

NCT00337610

Type 2 Diabetes Mellitus (T2DM)
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Placebo for PF-04991532 and sitagliptin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets (n=4), 0 mg twice daily for 84 days

25 mg PF-04991532

Group Type EXPERIMENTAL

25 mg PF-04991532

Intervention Type DRUG

Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days

75 mg PF-04991532

Group Type EXPERIMENTAL

75 mg PF-04991532

Intervention Type DRUG

Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days

150 mg PF-04991532

Group Type EXPERIMENTAL

150 mg PF-04991532

Intervention Type DRUG

Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days

300 mg PF-04991532

Group Type EXPERIMENTAL

300 mg PF-04991532

Intervention Type DRUG

Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days

Sitagliptin 100 mg

Group Type ACTIVE_COMPARATOR

Sitagliptin 100 mg

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Tablets (n=4), 0 mg twice daily for 84 days

Intervention Type DRUG

25 mg PF-04991532

Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days

Intervention Type DRUG

75 mg PF-04991532

Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days

Intervention Type DRUG

150 mg PF-04991532

Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days

Intervention Type DRUG

300 mg PF-04991532

Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Little Rock, Arkansas, United States

Site Status

Pfizer Investigational Site

Roseville, California, United States

Site Status

Pfizer Investigational Site

Denver, Colorado, United States

Site Status

Pfizer Investigational Site

Coral Gables, Florida, United States

Site Status

Pfizer Investigational Site

Ocala, Florida, United States

Site Status

Pfizer Investigational Site

Honolulu, Hawaii, United States

Site Status

Pfizer Investigational Site

Indianapolis, Indiana, United States

Site Status

Pfizer Investigational Site

Augusta, Kansas, United States

Site Status

Pfizer Investigational Site

Overland Park, Kansas, United States

Site Status

Pfizer Investigational Site

Wichita, Kansas, United States

Site Status

Pfizer Investigational Site

Lexington, Kentucky, United States

Site Status

Pfizer Investigational Site

Lake Charles, Louisiana, United States

Site Status

Pfizer Investigational Site

Auburn, Maine, United States

Site Status

Pfizer Investigational Site

Brooklyn Center, Minnesota, United States

Site Status

Pfizer Investigational Site

Las Vegas, Nevada, United States

Site Status

Pfizer Investigational Site

Trenton, New Jersey, United States

Site Status

Pfizer Investigational Site

Charlotte, North Carolina, United States

Site Status

Pfizer Investigational Site

Fargo, North Dakota, United States

Site Status

Pfizer Investigational Site

Cincinnati, Ohio, United States

Site Status

Pfizer Investigational Site

Lansdale, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Dallas, Texas, United States

Site Status

Pfizer Investigational Site

Katy, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

Norfolk, Virginia, United States

Site Status

Pfizer Investigational Site

Richmond, Virginia, United States

Site Status

Pfizer Investigational Site

Surrey, British Columbia, Canada

Site Status

Pfizer Investigational Site

Bay Roberts, Newfoundland and Labrador, Canada

Site Status

Pfizer Investigational Site

Brampton, Ontario, Canada

Site Status

Pfizer Investigational Site

Mississauga, Ontario, Canada

Site Status

Pfizer Investigational Site

Mirabel, Quebec, Canada

Site Status

Pfizer Investigational Site

Québec, Quebec, Canada

Site Status

Pfizer Investigational Site

Balatonfüred, , Hungary

Site Status

Pfizer Investigational Site

Kistelek, , Hungary

Site Status

Pfizer Investigational Site

Aguascalientes, Aguascalientes, Mexico

Site Status

Pfizer Investigational Site

Mexico City, Mexico City, Mexico

Site Status

Pfizer Investigational Site

Tlalnepantla, State of Mexico, Mexico

Site Status

Pfizer Investigational Site

Bratislava, , Slovakia

Site Status

Pfizer Investigational Site

Nové Mesto nad Váhom, , Slovakia

Site Status

Pfizer Investigational Site

Pezinok, , Slovakia

Site Status

Pfizer Investigational Site

Prešov, , Slovakia

Site Status

Pfizer Investigational Site

Taichung, , Taiwan

Site Status

Pfizer Investigational Site

Taoyuan, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Hungary Mexico Slovakia Taiwan

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2611003&StudyName=Study%20of%20Safety%20and%20Efficacy%20of%20PF-04991532%20in%20Subjects%20with%20Type%202%20Diabetes

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B2611003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)
NCT00541775 COMPLETED PHASE3
Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)
NCT01059825 COMPLETED PHASE2
A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)
NCT00813995 COMPLETED PHASE3
Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise (0431-158)
NCT00832390 COMPLETED PHASE4
A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin
NCT02551874 COMPLETED PHASE3
A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)
NCT00541450 COMPLETED PHASE3
Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)
NCT00875394 COMPLETED PHASE3
Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)
NCT00511108 COMPLETED PHASE1
Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)
NCT00541229 COMPLETED PHASE1
A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)
NCT00127192 COMPLETED PHASE2
Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)
NCT00704132 COMPLETED PHASE1
A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)
NCT00411554 COMPLETED PHASE3
Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251)
NCT01189890 COMPLETED PHASE3
Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130)
NCT01177384 COMPLETED PHASE3
30-Week Extension to an Initial Combination Study (24 Weeks in Duration) of Sitagliptin With Pioglitazone (0431-064)
NCT01028391 COMPLETED PHASE3
Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)
NCT00350779 COMPLETED PHASE3
Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)
NCT00449930 COMPLETED PHASE3
A Study to Assess the Addition of Sitagliptin to Metformin Compared With the Addition of Dapagliflozin to Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) and Mild Renal Impairment Who Have Inadequate Glycemic Control on Metformin With or Without a Sulfonylurea (MK-0431-838)
NCT02532855 COMPLETED PHASE3
A Study of the Safety and Efficacy of Sitagliptin Addition During Metformin Up-titration (MK-0431-848)
NCT02791490 COMPLETED PHASE3
The Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118)
NCT00832624 TERMINATED PHASE4
Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)
NCT00885352 COMPLETED PHASE3
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)
NCT00094757 COMPLETED PHASE3
MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)
NCT00103857 COMPLETED PHASE3
Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes
NCT01289990 COMPLETED PHASE3
Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes
NCT00838903 COMPLETED PHASE3