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

NCT01336738 | Completed Phase 2 Results DMC

• 1 other identifier: B2611002
• Study Type: interventional
• Target: 266
• Locations: 7 countries
• Sites: 44

Brief Summary

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.

Conditions

Diabetes, Type 2

Keywords

Phase 2; safety and efficacy study with PF-04991532; Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  Baseline, Week 1, 2, 4, 8

• Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels

  Week 12

• Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12

  Baseline, Week 1, 2, 4, 8, 12

• Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline

  Week 12

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Matching placebo for PF-04991532 and Sitagliptin

Drug: Placebo

150 mg PF-04991532

EXPERIMENTAL

Drug: 150 mg PF-04991532

450 mg PF-04991532

EXPERIMENTAL

Drug: 450 mg PF-04991532

750 mg PF-04991532

EXPERIMENTAL

Drug: 750 mg PF-04991532

Sitagliptin 100 mg

ACTIVE COMPARATOR

Drug: Sitagliptin 100 mg

Interventions

Placebo DRUG

Tablets (n=6), 0 mg, once daily for 84 days

Placebo

150 mg PF-04991532 DRUG

Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days

150 mg PF-04991532

450 mg PF-04991532 DRUG

Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days

450 mg PF-04991532

750 mg PF-04991532 DRUG

Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days

750 mg PF-04991532

Sitagliptin 100 mg DRUG

Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days

Sitagliptin 100 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (44)

Pfizer Investigational Site

Jonesboro, Arkansas, 72401, United States

Location

Pfizer Investigational Site

Jonesboro, Arkansas, 72404, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90057, United States

Location

Pfizer Investigational Site

Palm Springs, California, 92262, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32216, United States

Location

Pfizer Investigational Site

Melbourne, Florida, 32901, United States

Location

Pfizer Investigational Site

West Palm Beach, Florida, 33401, United States

Location

Pfizer Investigational Site

Conyers, Georgia, 30094, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60607, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40213, United States

Location

Pfizer Investigational Site

Fall River, Massachusetts, 02720, United States

Location

Pfizer Investigational Site

Brooklyn, New York, 11230, United States

Location

Pfizer Investigational Site

Cary, North Carolina, 27518, United States

Location

Pfizer Investigational Site

Wilmington, North Carolina, 28401, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43213, United States

Location

Pfizer Investigational Site

East Providence, Rhode Island, 02914, United States

Location

Pfizer Investigational Site

East Providence, Rhode Island, 02915, United States

Location

Pfizer Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

Pfizer Investigational Site

Bristol, Tennessee, 37620, United States

Location

Pfizer Investigational Site

Kingsport, Tennessee, 37660, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75230, United States

Location

Pfizer Investigational Site

Houston, Texas, 77036, United States

Location

Pfizer Investigational Site

Houston, Texas, 77074, United States

Location

Pfizer Investigational Site

Houston, Texas, 77081, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Charlottesville, Virginia, 22911, United States

Location

Pfizer Investigational Site

Kenosha, Wisconsin, 53142, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53209, United States

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Pfizer Investigational Site

Strathroy, Ontario, N7G 1Y7, Canada

Location

Pfizer Investigational Site

Thornhill, Ontario, L4J 8L7, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M9W 4L6, Canada

Location

Pfizer Investigational Site

Laval, Quebec, H7T 2P5, Canada

Location

Pfizer Investigational Site

Saint Romuald, Quebec, G6W 5M6, Canada

Location

Pfizer Investigational Site

Budapest, 1036, Hungary

Location

Pfizer Investigational Site

Guadalajara, Jalisco, 44130, Mexico

Location

Pfizer Investigational Site

Guadalajara, Jalisco, 44650, Mexico

Location

Pfizer Investigational Site

Monterrey, Nuevo León, 64460, Mexico

Location

Pfizer Investigational Site

Bratislava, 831 01, Slovakia

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 120-752, South Korea

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

Location

Pfizer Investigational Site

Tainan, 710, Taiwan

Location

Pfizer Investigational Site

Taipei, 100, Taiwan

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 18, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 6, 2013
• Results First Posted: August 6, 2013

Record last verified: 2013-06

Locations

TW (2); KR (3); HU (1); ME (3); CA (6); US (28); SL (1)