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

Diabetes Mellitus, 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 Twice Daily Pf-04991532 and Once Daily Sitagliptin in Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338870
• Other study ID #: B2611003
• Status: Completed
• Phase: Phase 2
• First received: April 13, 2011
• Last updated: March 11, 2013
• Start date: June 2011
• Est. completion date: March 2012

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• 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

Intervention

Drug:
• Placebo
Tablets (n=4), 0 mg twice daily for 84 days
• 25 mg PF-04991532
Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days
• 75 mg PF-04991532
Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days
• 150 mg PF-04991532
Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days
• 300 mg PF-04991532
Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days
• 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.

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Bay Roberts	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Brampton	Ontario
Canada	Pfizer Investigational Site	Mirabel	Quebec
Canada	Pfizer Investigational Site	Mississauga	Ontario
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Surrey	British Columbia
Hungary	Pfizer Investigational Site	Balatonfured
Hungary	Pfizer Investigational Site	Kistelek
Mexico	Pfizer Investigational Site	Aguascalientes
Mexico	Pfizer Investigational Site	Mexico	DF
Mexico	Pfizer Investigational Site	Tlalnepantla	Estado de Mexico
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Nove Mesto nad Vahom
Slovakia	Pfizer Investigational Site	Pezinok
Slovakia	Pfizer Investigational Site	Presov
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Taoyuan County
United States	Pfizer Investigational Site	Auburn	Maine
United States	Pfizer Investigational Site	Augusta	Kansas
United States	Pfizer Investigational Site	Brooklyn Center	Minnesota
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Coral Gables	Florida
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Fargo	North Dakota
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Katy	Texas
United States	Pfizer Investigational Site	Lake Charles	Louisiana
United States	Pfizer Investigational Site	Lansdale	Pennsylvania
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Norfolk	Virginia
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Roseville	California
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Trenton	New Jersey
United States	Pfizer Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Hungary,  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% 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	No
Secondary	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	No

External Links

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