Dapagliflozin During Exercise for the PrevenTion of Hypoglycaemia

Sponsor
University of Oxford
Study ID
NCT03537131
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 2, 2018
Status verified
Nov 2020
Primary completion
Jul 14, 2021
Completion
Jul 14, 2021

Study Design

Enrollment
9 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: arm B1- Dapagliflozin once only dose
    Participants who will take one tablet of Dapagliflozin 10 mg on the day of the exercise challenge.
  • Active Comparator: arm B2- Dapagliflozin daily administration
    Participants who will take a daily dose of Dapagliflozin 10 mg before and after the exercise challenge.

Primary Outcome Measure

Time to hypoglycaemia during the exercise challenge, before and after dapagliflozin treatment. [ Time Frame: 90min exercise challenge during Part A and Part B ]

Related Studies