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NCT01809327 - A Randomized, Double-Blind, 5-Arm, Parallel-Group, 26-Week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in Combination With Metformin as Initial Combination Therapy in the Treatment of Subjects Wit

A Randomized, Double-Blind, 5-Arm, Parallel-Group, 26-Week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in Combination With Metformin as Initial Combination Therapy in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise


CSR Summary

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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
1,186
Product Class
Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitor
Sponsor Protocol Number
28431754DIA3011
Data Holder
Johnson & Johnson
Condition Studied
Diabetes Mellitus, Type 2

Supporting Documentation

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

Disclaimer

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