Type 1 diabetes mellitus MedDRA version: 20.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Forxiga 10 mg film-coated tablets
Product Name: Forxiga 10 mg film-coated tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Dapaglifl
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >18 2. Type 1 diabetes diagnosed at least 12months prior to screening test 3. On insulin pump or multiple daily injections 4. HbA1c =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. History of seizure or coma associated with hypoglycaemia in the past 2 years 2. Active diabetic retinopathy (including proliferative diabetic retinopathy or vitreous haemorrhage in the past 6 months) 3. Pregnant or planning to become pregnant during the course of the study 4. History of ischemic heart disease (unless has had successful reperfusion), stroke/TIA, ventricular rhythm disturbances or thromboembolic disease 5. Renal impairment (eGFR <60ml/min/1.73m2) 6. Untreated Graves disease 7. ECG or stress test findings indicating active ischemia or a condition that would compromise the participant’s safety 8. Major psychiatric disease including diagnosed eating disorders, history of drug or alcohol abuse 9. Known or suspected allergy to trial medication 10. Oral or injectable steroid treatment 30 days prior to the start or at any time during the trial period 11. On beta-blocker medication 12. Known malignancy or any other condition or circumstance which, in the opinion of the investigator, would affect the patient’s ability to participate in the protocol 13. Receipt of any investigational trial drug within 3 month prior to participation in the current trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Time to hypoglycemia during exercise challenge (before and after dapagliflozin treatment), and between treatment groups.;Timepoint(s) of evaluation of this end point: Exercise challenge in part A and part B.;Main Objective: To determine whether dapagliflozin (either taken regularly or as a single dose) can delay/prevent the onset of hypoglycaemia during moderate intensity exercise.; Secondary Objective: 1. Whether dapagliflozin can prevent late-onset exercise-induced hypoglycaemia (overnight or the following day). 2. Measure the release of glucagon and somatostatin during and after exercise, on and off dapagliflozin. 3. Determine the changes in plasma electrolytes during exercise. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Duration of time in hypoglycaemia (categorised as <4mmol/L or <3mmol/L) from CGM recordings before and after dapagliflozin treatment, and between treatment groups. 2. Concentration of plasma glucose, glucagon and somatostatin-14 (pancreatic-specific) at each 10min interval during exercise challenge. 3. Concentration of plasma potassium, sodium, calcium and pH at each 10min interval during exercise challenge. ; Timepoint(s) of evaluation of this end point: 1. 24-hour period after each exercise challenge. 2. 10 minute intervals during each exercise challenge. 3. 10 minute intervals during each exercise challenge. | — |
Countries
United Kingdom
Outcome results
None listed