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NCT01517373 Clinical Trial

Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate Safety And Efficacy Of PF-04937319 And Glimepiride In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01517373
Other study ID # B1621002
Secondary ID
Status Completed
Phase Phase 2
First received January 20, 2012
Last updated April 21, 2014
Start date February 2012
Est. completion date January 2013

Study information
Verified date April 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a study to understand efficacy and safety of investigational agent (PF-04937319) compared to approved agent (glimepiride) in patients with diabetes on metformin

Recruitment information / eligibility
Status Completed
Enrollment 305
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent

Exclusion Criteria:

- Subjects with recent cardiovascular events, those with evidence of diabetic complications

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Combination of tablets and capsules, a total of 3 pills/dose, administered once daily for 84-days
• PF-04937319 10 mg
Combination of tablets and capsules, dose of 10 mg, a total of 3 pills/dose, administered once daily for 84-days
• PF-04937319 50 mg
Combination of tablets and capsules, dose of 50 mg, a total of 3 pills/dose, administered once daily for 84-days
• PF-04937319 100 mg
Combination of tablets and capsules, dose of 100 mg, a total of 3 pills/dose, administered once daily for 84-days
• Glimepiride
Combination of tablets and capsules, dose of up to 6 mg, a total of 3 pills/dose, administered once daily for 84-days

Locations
Country Name City State
Bulgaria Pfizer Investigational Site Byala
Bulgaria Pfizer Investigational Site Ruse
Bulgaria Pfizer Investigational Site Sevlievo
Bulgaria Pfizer Investigational Site Sofia
Bulgaria Pfizer Investigational Site Sofia
Bulgaria Pfizer Investigational Site Stara Zagora
Canada Pfizer Investigational Site Brampton Ontario
Canada Pfizer Investigational Site Langley British Columbia
Canada Pfizer Investigational Site Quebec
Canada Pfizer Investigational Site St-Romuald Quebec
Canada Pfizer Investigational Site Strathroy Ontario
Canada Pfizer Investigational Site Surrey British Columbia
Canada Pfizer Investigational Site Terrebonne Quebec
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Winnipeg Manitoba
Hungary Pfizer Investigational Site Balassagyarmat
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Szekesfehervar
India Pfizer Investigational Site Bangalore Karnataka
India Pfizer Investigational Site Pune Maharashtra
India Pfizer Investigational Site Pune Maharashtra
Slovakia Pfizer Investigational Site Banska Bystrica
Slovakia Pfizer Investigational Site Moldava Nad Bodvou
Slovakia Pfizer Investigational Site Nove Zamky
Slovakia Pfizer Investigational Site Pezinok
Slovakia Pfizer Investigational Site Zilina
Taiwan Pfizer Investigational Site Taichung
Taiwan Pfizer Investigational Site Taipei
Taiwan Pfizer Investigational Site Taipei
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Bradenton Florida
United States Pfizer Investigational Site Bristol Tennessee
United States Pfizer Investigational Site Bryan Texas
United States Pfizer Investigational Site Chattanooga Tennessee
United States Pfizer Investigational Site Chattanooga Tennessee
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Honolulu Hawaii
United States Pfizer Investigational Site Hyannis Massachusetts
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site Morehead City North Carolina
United States Pfizer Investigational Site Mount Pleasant South Carolina
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site Norfolk Virginia
United States Pfizer Investigational Site Pembroke Pines Florida
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 San Diego California
United States Pfizer Investigational Site Walnut Creek California

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Hungary,  India,  Slovakia,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline over 12-weeks in glycosylated hemoglobin - HbA1C up to 12 weeks No
Secondary Change from Baseline over 12-weeks in fasting plasma glucose up to 12 weeks No
Secondary Proportion of Subjects achieving HbA1C <6.5% and <7% at Week 12 12 weeks No
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