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NCT00968812 - A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus

A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy

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Data Specification

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Annotated CRF

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Product Info

Generic Name
Canagliflozin
Product Name
INVOKANA®
Therapeutic Area
Nutritional and Metabolic Diseases
Enrollment
1,452
% Female
48.0%
% White
67.0%
Product Class
Diabetes Related- Other
Sponsor Protocol Number
28431754DIA3009
Data Holder
Johnson & Johnson
Condition Studied
Diabetes Mellitus, Type 2
Mean/Median Age (Years)
57.0

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Data Definition Specification
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

Disclaimer

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