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Do SGLT2 inhibitors cause more adverse events & safety than other treatments?
Also asked versus placebo.
Not modeled yetTrial evidence exists, but no mechanistic model yetWithout a model there is no decisive experiment to propose. Help build it. →
Where the evidence stands
Unlikely. So far, the results disagree.
NoUnsureYes
- Belief
- 0.20 (range 0.00–0.55)
- Trials for
- 2
- Trials against
- 8
- Inconclusive
- 3
Already under way
No registered trial that could settle this is recruiting or active.
The evidence so far
- Registered trials
- 375
- With posted results
- 95
- Published papers
- 29
Of 166 decided analyses: 48 favor sglt2 inhibitors, 99 find no difference, 19 favor the comparator.
Papers
- The sodium-glucose cotransporter-2 inhibitor canagliflozin does not increase risk of non-genital skin and soft tissue infections in people with type 2 diabetes mellitus: A pooled post hoc analysis from the CANVAS Program and CREDENCE randomized double-blind trials.Trial report · 2023
- Reasons for hospitalizations in patients with type 2 diabetes in the CANVAS programme: A secondary analysis.Trial report · 2021
- Bexagliflozin as an adjunct to metformin for the treatment of type 2 diabetes in adults: A 24-week, randomized, double-blind, placebo-controlled trial.Trial report · 2023
- Efficacy and safety of ipragliflozin as an add-on therapy to sitagliptin and metformin in Korean patients with inadequately controlled type 2 diabetes mellitus: A randomized controlled trial.Trial report · 2018
- Effects of canagliflozin on serum potassium in people with diabetes and chronic kidney disease: the CREDENCE trial.Trial report · 2021
- Adverse drug events observed in patients with type 2 diabetes mellitus treated with 100 mg versus 300 mg canagliflozin: a systematic review and meta-analysis of published randomized controlled trials.Meta-analysis / systematic review · 2017
Trials
- A Meta-Analysis of Amputation Risk in Empagliflozin Studies (1245.25, 1245.110, 1245.121)NCT04937816 · 35 posted results
- A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-3)NCT02580591 · 12 posted results
- A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of Empagliflozin as Adjunctive to inSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)NCT02414958 · 8 posted results
- Cardiovascular Outcomes, and Mortality in Danish Patients With Type 2 Diabetes Who Initiate Empagliflozin Versus Glucagon-Like Peptide-1 Receptor Agonists (GLP1-RA): A Danish Nationwide Comparative Effectiveness Study [EMPLACEtm]NCT03993132 · 8 posted results
- A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes MellitusNCT01719003 · 10 posted results
- 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 ExerciseNCT01809327 · 9 posted results
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 18-Week Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a SulphonylureaNCT01381900 · 6 posted results
- A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ-28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes MellitusNCT01032629 · 8 posted results