Study Phase
3
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
Data Specification
Not Available
Annotated CRF
Not Available
Trial Information
Generic Name
Canagliflozin
Product Name
INVOKANA®
Therapeutic Area
Nutritional and Metabolic Diseases
Enrollment
1,186
% Female
52.0%
% White
81.6%
Product Class
Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitor
Sponsor Protocol Number
28431754DIA3011
Data Partner
Johnson & Johnson
Condition Studied
Diabetes Mellitus, Type 2
Mean/Median Age (Years)
54.9
Supporting Documentation
Clinical Study Report
Collected Datasets
Data Definition Specification
Annotated Case Report Form
Protocol with Amendments
Statistical Analysis Plan
APPROVED DATA REQUESTS ASSOCIATED WITH THIS TRIAL
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