Diabetes Mellitus, Type 1Phase 2DEPTHNCT03537131
Dapagliflozin During Exercise for the PrevenTion of Hypoglycaemia
A Phase 2 study testing Dapagliflozin 10 MG Oral Tablet in people with Diabetes Mellitus, Type 1, run by University of Oxford at 1 site in United Kingdom.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Dapagliflozin 10 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jun 2018to 14 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-74
- T1DM diagnosed at least 12 months prior to screening test
- On insulin pump or multiple daily injections
- HbA1c <10% (86 mmol/L)
- Engage in some form of regular exercise
- Have experienced at least one episode of exercise-induced hypoglycaemia
Show all 10Show fewer
- Adequate treatment of celiac disease if it exists.
- Willing and able to give informed consent for participation in the trial
- In the Investigator's opinion is able and willing to comply with all trial requirements
- Will allow their General Practitioner to be notified of participation in the trial.
Who cannot join
- History of seizures or coma associated with hypoglycaemia in the past 2 years.
- Active diabetic retinopathy ( including proliferative diabetic retinopathy or vitreous haemorrhage in the past 6 months).
- Pregnant, breastfeeding, planning to become pregnant or not using adequate contraception methods (females only) during the course of the study
- History of ischemic heart disease ( unless has had successful reperfusion), stroke/TIA, ventricular rhythm disturbances or thromboembolic disease.
- A history of hypotension if currently on antihypertensive therapy
- An episode of diabetic ketoacidosis in the previous 1 month
Show all 18Show fewer
- Currently on loop diuretics
- On beta-blocker medication
- A history of heart failure (NYHA Class 3 or 4)
- A history of rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
- Renal impairment ( eGFR<60 ml/min/1.73m2)
- Untreated Graves disease
- ECG or stress test findings indicating active ischemia or a condition that would compromise the participant's safety
- Major psychiatric disease including diagnosed eating disorders, history of drug or alcohol abuse.
- Known or suspected allergy to trial medication
- Oral or injectable steroid treatment 30 days prior to the start or at any time during the trial period
- Known malignancy or any other condition or circumstances which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol.
- Receipt of any investigational trial drug within 3 months prior to participation in the current trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Unit, OCDEM, Churchill Hospital
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: Dapagliflozin During Exercise for the Prevention of Hypoglycaemia in Type 1 Diabetes
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.
Read more
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.
Read the detailed description
PART A Study visit 1 (30min, day 1): 1. Observations documented in CRF: resting heart rate and blood pressure 2. CGM sensor inserted. 3. Insulin dose reduced by approximately 15%. 4. Participants instructed to return on day 3 (study visit 2) fasted (no breakfast), and to refrain from exercising until then. 5. If they experience a hypoglycaemic episode within 24h of visit 2 then it will be postponed by 2 days. The medical research team will review the participant's insulin dose and make any required changes. If following this a second hypoglycaemia event occurs, then the participant will be withdrawn from the trial.
Study visit 2 (5 hours, day 3): 1. Observations documented in CRF: resting heart rate and blood pressure 2. Euglycaemic clamp for up to 1.5h to maintain blood glucose at 5mmol/L (90mg/dL) 3. Exercise challenge 4. If a participant fails to reach hypoglycaemia (defined as <3.3mmol/L, 60mg/dL) during the exercise challenge, then the study visit will be repeated after at least 2 days of washout/rest. If they again fail to reach hypoglycaemia then they will be withdrawn from the trial. 5. If the exercise challenge is completed with a hypoglycaemia episode, then the participant will proceed to Part B.
Following visit 2, participants will be allocated to a treatment group using an adaptive randomisation scheme. This will be used to balance the groups' baseline characteristics (age, sex \& fitness level) in this relatively small pilot trial.
PART B Study visit 3 (30 minutes, day 8): 1. Observations documented in CRF: resting heart rate and blood pressure 2. CGM sensor inserted (if required). 3. Participants informed which arm of the study they have been randomised to, and supplied with their prescription of dapagliflozin. Participants in arm B1 will take the single dose when they attend study visit 4. Participants in arm B2 will begin taking their regular dose of dapagliflozin immediately. 4. Participants instructed to return on day 10 (study visit 4) fasted (no breakfast), and to refrain from exercising until then. 5. If they experience a hypoglycaemic episode within 24h of visit 4 then the exercise challenge will be postponed by 2 days. The medical research team will review the participant's insulin dose and make any required changes. If following this a second hypoglycaemia event occurs, then the participant will be withdrawn from the trial.
Study visit 4 (5 hours; day 10): 1. Observations documented in CRF: resting heart rate and blood pressure 2. (Arm B1): single dose of dapagliflozin taken when they arrive at the department unless they have experienced a hypoglycaemia event earlier in the morning. (Arm B2): compliance with dapagliflozin regimen and adverse events recorded in the CRF by the medical research team. 3. Euglycaemic clamp for up to 1.5h to maintain blood glucose at 5mmol/L (90mg/dL) 4. Exercise challenge 5. Participants in Arm B2 will be instructed to take one final dose of dapagliflozin the following day. All participants will be instructed to return to their pre-trial insulin dose after 48h 6. Arrangements made for end of study visit (either at CRU or home-visit).
Study visit 5 (30min; day 12-20): 1. End of study visit (either at CRU or home-visit) 2. CGM sensor removed and data downloaded. CGM system returned to CRU. 3. (Arm B1): adverse events recorded. (Arm B2): compliance with dapagliflozin regimen, adverse events recorded and any unused dapagliflozin returned (document drug accountability).
Telephone follow-up (15min; 19-27 days after study visit 5): 1. Documentation of any adverse events occurred following the discontinuation of dapagliflozin. 2. Participant informed about end of study
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Dapagliflozin 10 MG Oral Tablet
- Keywords
- diabetes, dapagliflozin, exercise, hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Motor Activity, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 MG Oral TabletDrug
Also called forxiga
taken once a day
| Study group | Role | What they receive |
|---|---|---|
| arm B1- Dapagliflozin once only dose | Active comparator | Participants who will take one tablet of Dapagliflozin 10 mg on the day of the exercise challenge. Receives: Drug: Dapagliflozin 10 MG Oral Tablet |
| arm B2- Dapagliflozin daily administration | Active comparator | Participants who will take a daily dose of Dapagliflozin 10 mg before and after the exercise challenge. Receives: Drug: Dapagliflozin 10 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90min exercise challenge during Part A and Part B
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: Every 10min during the 90min exercise challenge during Part A and Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start2 Jun 2018
- Primary completion14 Jul 2021
- Study completion14 Jul 2021
Why it stopped: Temporary halt due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Oxford Brookes University
- Responsible party
- Sponsor
- Investigators
- Ioannis Spiliotis, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537131
- Sponsor's protocol ID
- 23092017
- Other IDs
- 2017-003911-21, 2017
- Acronym
- DEPTH
- Status last verified
- Nov 2020
- First submitted
- 25 Apr 2018
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dapagliflozin During Exercise for the Prevention of Hypoglycaemia in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03537131
- Acronym / sponsor ID
- DEPTH / 23092017
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- diabetes, dapagliflozin, exercise, hypoglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Temporary halt due to COVID-19 pandemic
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Oxford Brookes University
- Study start
- 2 Jun 2018 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PART A Study visit 1 (30min, day 1): 1. Observations documented in CRF: resting heart rate and blood pressure 2. CGM sensor inserted. 3. Insulin dose reduced by approximately 15%. 4. Participants instructed to return on day 3 (study visit 2) fasted (no breakfast), and to refrain from exercising until then. 5. If they experience a hypoglycaemic episode within 24h of visit 2 then it will be postponed by 2 days. The medical research team will review the participant's insulin dose and make any required changes. If following this a second hypoglycaemia event occurs, then the participant will be withdrawn from the trial.
Study visit 2 (5 hours, day 3): 1. Observations documented in CRF: resting heart rate and blood pressure 2. Euglycaemic clamp for up to 1.5h to maintain blood glucose at 5mmol/L (90mg/dL) 3. Exercise challenge 4. If a participant fails to reach hypoglycaemia (defined as <3.3mmol/L, 60mg/dL) during the exercise challenge, then the study visit will be repeated after at least 2 days of washout/rest. If they again fail to reach hypoglycaemia then they will be withdrawn from the trial. 5. If the exercise challenge is completed with a hypoglycaemia episode, then the participant will proceed to Part B.
Following visit 2, participants will be allocated to a treatment group using an adaptive randomisation scheme. This will be used to balance the groups' baseline characteristics (age, sex \& fitness level) in this relatively small pilot trial.
PART B Study visit 3 (30 minutes, day 8): 1. Observations documented in CRF: resting heart rate and blood pressure 2. CGM sensor inserted (if required). 3. Participants informed which arm of the study they have been randomised to, and supplied with their prescription of dapagliflozin. Participants in arm B1 will take the single dose when they attend study visit 4. Participants in arm B2 will begin taking their regular dose of dapagliflozin immediately. 4. Participants instructed to return on day 10 (study visit 4) fasted (no breakfast), and to refrain from exercising until then. 5. If they experience a hypoglycaemic episode within 24h of visit 4 then the exercise challenge will be postponed by 2 days. The medical research team will review the participant's insulin dose and make any required changes. If following this a second hypoglycaemia event occurs, then the participant will be withdrawn from the trial.
Study visit 4 (5 hours; day 10): 1. Observations documented in CRF: resting heart rate and blood pressure 2. (Arm B1): single dose of dapagliflozin taken when they arrive at the department unless they have experienced a hypoglycaemia event earlier in the morning. (Arm B2): compliance with dapagliflozin regimen and adverse events recorded in the CRF by the medical research team. 3. Euglycaemic clamp for up to 1.5h to maintain blood glucose at 5mmol/L (90mg/dL) 4. Exercise challenge 5. Participants in Arm B2 will be instructed to take one final dose of dapagliflozin the following day. All participants will be instructed to return to their pre-trial insulin dose after 48h 6. Arrangements made for end of study visit (either at CRU or home-visit).
Study visit 5 (30min; day 12-20): 1. End of study visit (either at CRU or home-visit) 2. CGM sensor removed and data downloaded. CGM system returned to CRU. 3. (Arm B1): adverse events recorded. (Arm B2): compliance with dapagliflozin regimen, adverse events recorded and any unused dapagliflozin returned (document drug accountability).
Telephone follow-up (15min; 19-27 days after study visit 5): 1. Documentation of any adverse events occurred following the discontinuation of dapagliflozin. 2. Participant informed about end of study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm B1- Dapagliflozin once only dose | Active comparator | Drug: Dapagliflozin 10 MG Oral TabletParticipants who will take one tablet of Dapagliflozin 10 mg on the day of the exercise challenge. |
| arm B2- Dapagliflozin daily administration | Active comparator | Drug: Dapagliflozin 10 MG Oral TabletParticipants who will take a daily dose of Dapagliflozin 10 mg before and after the exercise challenge. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-74
- T1DM diagnosed at least 12 months prior to screening test
- On insulin pump or multiple daily injections
- HbA1c <10% (86 mmol/L)
- Engage in some form of regular exercise
Key exclusion criteria (18 listed)
- History of seizures or coma associated with hypoglycaemia in the past 2 years.
- Active diabetic retinopathy ( including proliferative diabetic retinopathy or vitreous haemorrhage in the past 6 months).
- Pregnant, breastfeeding, planning to become pregnant or not using adequate contraception methods (females only) during the course of the study
- History of ischemic heart disease ( unless has had successful reperfusion), stroke/TIA, ventricular rhythm disturbances or thromboembolic disease.
- A history of hypotension if currently on antihypertensive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10 MG Oral TabletAlso: forxigataken once a day | Drug | arm B1- Dapagliflozin once only dose, arm B2- Dapagliflozin daily administration |
Primary outcome
Time to hypoglycaemia during the exercise challenge, before and after dapagliflozin treatment.
Time frame: 90min exercise challenge during Part A and Part B
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.
3 secondary outcomes
Duration of time in hypoglycaemia following the exercise challenge, before and after dapagliflozin treatment.
Time frame: 24-hour period after each exercise challenge
Concentration of plasma glucose, glucagon and somatostatin-14 at each 10min interval during the exercise challenge.
Time frame: 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
Time frame: Every 10min during the 90min exercise challenge during Part A and Part B
Results and safety
The study was stopped early (reason given: Temporary halt due to COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis Spiliotis, MD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin 10 MG Oral Tablet in people with Diabetes Mellitus, Type 1, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Temporary halt due to COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.