Pilot Study to Explore the Efficacy of DAPAglifozin as add-on to Closed-loop Control in Patients With Type 1 Diabetes

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.

Timeline

Start

2017-02-09

Primary completion

2017-12-19

Completion

2017-12-19

Drugs

Indications