Dapagliflozin during exercise for the prevention of hypoglycaemia in Type 1 diabetes - Dapagliflozin during Exercise for the PrevenTion of Hypos (DEPTH)

niversity of Oxford0 个研究点目标入组 34 人开始时间: 2018年4月6日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•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 <10% (86mmol/mol)
•5. Engage in some form of regular exercise
•6. Have experienced at least one episode of exercise-induced hypoglycaemia
•7. Adequate treatment of celiac disease if it exists.
•8. Willing and able to give informed consent for participation in the trial
•9. In the Investigator’s opinion is able and willing to comply with all trial requirements
•10. Willing to allow their General Practitioner and/or consultant, if appropriate, to be notified of participation in the trial.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 34
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 0

•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.

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