| Trial ID: | L2071 |
| Source ID: | NCT03537131
|
| Associated Drug: |
Dapagliflozin 10 Mg Oral Tablet
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| Title: |
Dapagliflozin During Exercise for the PrevenTion of Hypoglycaemia
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| Acronym: |
DEPTH
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| Status: |
TERMINATED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
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| Interventions: |
DRUG: Dapagliflozin 10 MG Oral Tablet
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| Outcome Measures: |
Primary: Time to hypoglycaemia during the exercise challenge, before and after dapagliflozin treatment., To determine whether dapagliflozin (either regular or as a single dose) can delay/prevent the onset of hypoglycaemia during moderate intensity exercise. Following blood glucose stabilisation at 5mmol/L (90mg/dL) during the euglycaemic clamp, participants will begin exercising at moderate intensity (50-60% VO2 max) for up to 90min. Time to hypoglycaemia (defined as blood glucose \<3.3mmol/L, 60mg/dL) will be determined before (Part A) and after (Part B) dapagliflozin treatment., 90min exercise challenge during Part A and Part B | Secondary: Duration of time in hypoglycaemia following the exercise challenge, before and after dapagliflozin treatment., To determine whether dapagliflozin can prevent late-onset exercise-induced hypoglycaemia (categorised as \<4mmol/L or \<3mmol/L from continuous glucose monitoring recordings) overnight or the following day, before and after dapagliflozin treatment and between treatment groups (B1: single dose; B2: regular dose)., 24-hour period after each exercise challenge|Concentration of plasma glucose, glucagon and somatostatin-14 at each 10min interval during the exercise challenge., To characterise the secretion of glucagon and somatostatin during and after exercise, on and off dapagliflozin. The concentration of plasma glucose, glucagon and somatostatin-14 (pancreatic- specific) at each 10min interval during the exercise challenge will be measured before (Part A) and after (Part B) dapagliflozin treatment., Every 10min during the 90min exercise challenge during Part A and Part B|Concentration of plasma potassium, sodium, calcium and pH at each 10min interval during exercise challenge, To determine the plasma electrolyte changes during exercise. The concentration of plasma potassium, sodium, calcium and pH at each 10min interval during exercise challenge will be measured before (Part A) and after (Part B) dapagliflozin treatment., Every 10min during the 90min exercise challenge during Part A and Part B
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| Sponsor/Collaborators: |
Sponsor: University of Oxford | Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust|Oxford Brookes University
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
9
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
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| Start Date: |
2018-06-02
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| Completion Date: |
2021-07-14
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| Results First Posted: |
|
| Last Update Posted: |
2022-05-18
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| Locations: |
Clinical Research Unit, OCDEM, Churchill Hospital, Oxford, Oxfordshire, OX3 7LE, United Kingdom
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| URL: |
https://clinicaltrials.gov/show/NCT03537131
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