Trial Information
Generic NameCanagliflozinProduct NameINVOKANA®Therapeutic AreaNutritional and Metabolic DiseasesEnrollment1284% Female52.9%% White70.2%
Product ClassDiabetes Related- OtherSponsor Protocol Number28431754DIA3006Data PartnerJohnson & JohnsonCondition StudiedDiabetes Mellitus, Type 2Mean/Median Age (Years)56
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2024-0916 : Synthetic control arm studies for causal inference evaluation
- 2024-0600 : Bayesian machine learning for the identification of benefiting subgroups and treatment effect heterogeneity for canagliflozin in T2DM patients
- 2024-0580 : Developing approaches to accelerate clinical trials using real world data (RWD) from electronic health records (EHR)
- 2024-0060 : Using Synthetic Controls to Improve Randomised Controlled Trials for Rare Diseases
- 2023-5195 : Predictive modeling of adverse events and symptoms patterns in large scale clinical trials
- 2022-5124 : Understanding frailty, multimorbidity and renal failure in clinical trials: Attrition, retention and heterogeneity of treatment effects in trials
- 2022-5045 : Network MA of RCTs to compare the effects of metabolic surgery vs. modern drug treatment on cardiovascular outcomes + mortality in patients with DMT2
- 2021-4814 : A systematic review and network meta-analysis (NMA) to determine the best second-line therapy for type 2 diabetes mellitus in people aged 65 and over
- 2021-4764 : Reporting of harms in SGLT2 clinical study reports compared to trial registries and publications: a methodological review
- 2020-4465 : Examination of implications of acute declines in kidney function with SGLTII inhibitors
- 2020-4417 : Vibration of effects in pooled analyses of Canagliflozin vs placebo, randomized, double blind trials
- 2020-4211 : The effect of SGLT2 inhibitors in diabetes subgroups identified by data-driven clustering
- 2019-4077 : Evaluation of debiased machine learning methods to estimate the average treatment effect in observational studies.
- 2019-4071 : Efficacy and safety of SGLT2 inhibitors in the treatment of type 2 diabetes: systematic review incorporating unpublished clinical study reports
- 2019-3995 : Cardiovascular safety associated with SGLT-2 inhibitors across racial groups in patients with T2DM: a meta analysis and systematic review.
- 2017-1816 : MASTERMIND: Stratification of response to SGLT2 inhibitor glucose lowering therapy
- 2017-1746 : Heterogeneity in relative treatment efficacy by age, sex, socioeconomic status and comorbidity
- 2017-1466 : The use of clinical experimental data to build personalized medicine models and the evaluation of their effectiveness and statistical significance.
- 2016-1026 : Making Better Use of Randomized Trials: Assessing Applicability and Transporting Causal Effects
- 2015-0416 : Bone safety of canagliflozin, aSGLT2 inhibitor, in type 2 diabetes: A retrospective analysis to evaluate fracture risk
- 2014-0340 : The effects of SGLT-2 inhibitors in patients with type 2 diabetes: a systematic review with meta-analysis of randomised trials