drugset / Trial / NCT02429258

Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin

NCT02429258 ↗

Phase 4 Completed 226 enrolled AstraZeneca
RandomizedParallel-groupTriple-blindTreatment

Summary

Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

Timeline

Start
2015-05
Primary completion
2015-10
Completion
2015-10

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Dapagliflozin: -18.2 (Standard Error 4.33) mg/dL LEAST_SQUARES_MEAN Placebo: 5.8 (Standard Error 4.25) mg/dL NCT02429258 ↗

registry Dapagliflozin vs Placebo; p <0.001; Mean Difference (Final Values) -24.0 (95% CI -36.1 to -12.0) NCT02429258 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Forxiga Unknown 10 mg —
Background Insulin Protein / enzyme biologic 30 iu —
Background Metformin Small molecule 1500 mg —