NCT03537131: DEPTH

Dapagliflozin During Exercise for the PrevenTion of Hypoglycaemia

Terminated Phase 2 Last updated 18 May 2022

What this trial tests

Phase 2 trial testing Dapagliflozin 10 MG Oral Tablet in Diabetes Mellitus, Type 1 in 9 participants. Terminated before completion.

Timeline

2 June 2018

Primary endpoint
14 July 2021

14 July 2021

Quick facts

Lead sponsor	University of Oxford
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	9
Start date	2 June 2018
Primary completion	14 July 2021
Estimated completion	14 July 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

• Dapagliflozin 10 MG Oral Tablet

Conditions studied

• Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

University of Oxford

Who can join

Adults 18 to 74, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There are approximately 400,000 people in the UK who are living with type 1 diabetes (T1DM), of whom 29,000 are children.

People with T1DM experience on average 2 episodes of symptomatic hypoglycaemia per week , and exercise (especially aerobic) increases this risk . Strategies to prevent hypoglycaemia during and after exercise include increasing glucose consumption and reducing insulin dose, however overcompensation may result in worsening of blood glucose control.

Dysregulated glucagon secretion, manifested as a reduced counter-regulatory response during hypoglycaemia, is a key feature in T1DM, occurring soon after diagnosis.

Anecdotal evidence suggests that SGLT-2 (sodium/glucose cotransporter-2) inhibitors (SGLT2i) such as dapagliflozin prevent exercise-induced hypoglycaemia in T1DM. SGLT2is promote glucose excretion without causing hypoglycaemia.Paradoxically, given their mode of action, they increase plasma glucose and stimulate glucagon secretion. Studies in diabetic rats indicate that the physiological counter-regulatory response is suppressed in insulin-treated diabetes, a defect that can be corrected by somatostatin antagonists.

The DEPTH trial will test the novel hypothesis that hypoglycaemia results from hypersecretion of somatostatin, and that this defect can be corrected by SGLT2i. As these medications are already in clinical use, our findings may be rapidly translated into practice. Understanding these key processes has the potential to generate novel therapeutic strategies to improve glycaemic control, thereby facilitating a more active lifestyle in people with T1DM.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Partial restoration of counterregulatory circulating glucagon by dapagliflozin and low-dose glibenclamide in men with type 1 diabetes: in vitro studies and randomised clinical crossover trial.
   Gao R, Spiliotis I, Dou H, Hill TG, et al · · 2026 · PMID 42155411 · DOI 10.1016/j.ebiom.2026.106298