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

Diabetes, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336738
• Other study ID #: B2611002
• Status: Completed
• Phase: Phase 2
• First received: April 13, 2011
• Last updated: June 5, 2013
• Start date: June 2011
• Est. completion date: March 2012

Study information

• Verified date: June 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Type 2

Intervention

Drug:
• Placebo
Tablets (n=6), 0 mg, once daily for 84 days
• 150 mg PF-04991532
Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days
• 450 mg PF-04991532
Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days
• 750 mg PF-04991532
Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days
• Sitagliptin 100 mg
Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Laval	Quebec
Canada	Pfizer Investigational Site	St-Romuald	Quebec
Canada	Pfizer Investigational Site	Strathroy	Ontario
Canada	Pfizer Investigational Site	Thornhill	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Hungary	Pfizer Investigational Site	Budapest
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Monterrey	Nuevo Leon
Slovakia	Pfizer Investigational Site	Bratislava
Taiwan	Pfizer Investigational Site	Tainan
Taiwan	Pfizer Investigational Site	Taipei
United States	Pfizer Investigational Site	Bristol	Tennessee
United States	Pfizer Investigational Site	Brooklyn	New York
United States	Pfizer Investigational Site	Cary	North Carolina
United States	Pfizer Investigational Site	Charlottesville	Virginia
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Conyers	Georgia
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	East Providence	Rhode Island
United States	Pfizer Investigational Site	East Providence	Rhode Island
United States	Pfizer Investigational Site	Fall River	Massachusetts
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Jonesboro	Arkansas
United States	Pfizer Investigational Site	Jonesboro	Arkansas
United States	Pfizer Investigational Site	Kenosha	Wisconsin
United States	Pfizer Investigational Site	Kingsport	Tennessee
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Melbourne	Florida
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	Mount Pleasant	South Carolina
United States	Pfizer Investigational Site	Palm Springs	California
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Hungary,  Korea, Republic of,  Mexico,  Slovakia,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12		Baseline, Week 1, 2, 4, 8, 12	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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