Table 5.
Trials of dapagliflozin in patients with type 1 diabetes mellitus currently registered on ClinicalTrials.gov
| ClinicalTrials.gov identifier | Phase (status) | Study design | Dose | Main objectives |
|---|---|---|---|---|
| NCT02325206 | I (Recruiting) | Randomized, placebo controlled, crossover | 10 mg (single dose) | Safety and pharmacokinetics; degree of insulin dose reduction after 24-h |
| NCT01498185a | II (Completed) | Randomized, double-blind, placebo controlled | 1, 2.5, 5, 10 mg × 14 days | Safety, change from baseline mean plasma glucose, pharmacokinetics and pharmacodynamics |
| NCT02268214 | III (Recruiting) | Randomized, double blind, placebo controlled | 5 or 10 mg × 52 weeks | Efficacy (change in HbA1c at week 24; change from baseline insulin dose, metabolic parameters. |
| NCT02211742 | IV (Recruiting) | Randomized, double-blind, crossover | 10 mg × 3 days | Effect of dapagliflozin on fasting glucose homeostasis and postprandial glucose excursions in male patients |
aHenry et al. [81]