Pilot Study to Explore the Efficacy of DAPAglifozin as add-on to Closed-loop Control in Patients With Type 1 Diabetes
Status:
Completed
Trial end date:
2017-12-19
Target enrollment:
Participant gender:
Summary
Dapagliflozin has a unique mechanism of action that does not directly affect either insulin
resistance or insulin secretion, but rather improves glycemia by reduction of glucose
re-absorption from proximal renal tubules. Dapagliflozin is expected to reduce mean daily
glucose, improve glycemic control and reduce overall insulin requirements. Improved glycemic
control with reduced variability may also lead to reduced frequency of hypoglycemia.
In youth with T1D, Dapagliflozin led to a significant reduction of insulin needed to achieve
target glucose irrespective of preexisting HbA1c levels.
In this pilot study data will be collected to investigate the effect on glucose of two doses
of 10mg (each) dapagliflozin within range for the ensuing 24 hours during the DreaMed
automated insulin delivery in patients with type 1 diabetes dosing with dapagliflozin in an
in-patient setting combined with an automated sensor based CE marked insulin delivery system
to data if dapagliflozin is a suitable add-on therapy. This will provide optimal monitoring
of subject safety and assessment of the effects of dapagliflozin in a structured setting.
If this inpatient study shows evidence that Dapagliflozin is a suitable add on therapy and
leads to an increase of time within the target glucose range when using a sensor based
insulin pump therapy (closed-loop) further outpatient studies are planned to be conducted.