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Study characteristics
Methods	Design: cross‐over RCT; non‐inferiority design; randomisation ratio: 1:1
Participants	Inclusion criteria: fulfilling at least one of the below criteria: experienced at least one severe hypoglycaemic episode within the last year (according to the ADA definition, April 2013); moderate chronic renal failure, defined as glomerular filtration rate 30 ‐ 59 mL/min/1.73 m2 per chronic kidney disease epidemiology collaboration; hypoglycaemic symptom unawareness; diabetes mellitus duration for more than 15 years; recent episode of hypoglycaemia within the last 12 weeks: male or female; age at least 18 years at the time of signing informed consent; T1DM (diagnosed clinically) for at least 52 weeks; current treatment with a basal‐bolus regimen consisting of NPH insulin once daily/twice daily or insulin detemir once daily/twice daily plus 2‐4 daily injections of any rapid‐acting meal time insulin or continuous subcutaneous insulin infusion (with rapid‐acting insulin) for at least 26 weeks; HbA1c below or equal to 10%; BMI below or equal to 45 kg/m2 Exclusion criteria: known or suspected hypersensitivity to study product(s) or related products; previous participation in this study; female who is pregnant, breastfeeding or intends to become pregnant or is of child‐bearing potential and not using adequate contraceptive methods; treatment with glargine or degludec within the last 26 weeks; use of any other glucose‐lowering drug than those stated in the inclusion criteria within the last 26 weeks; receipt of any investigational medicinal product within 4 weeks prior to screening; any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise the safety or compliance with the protocol: current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma); stroke, decompensated NYHA class III or IV, myocardial infarction, unstable angina pectoris, or coronary arterial bypass graft or angioplasty, all within the last 26 weeks; uncontrolled or untreated severe hypertension defined as systolic BP ≥ 180 mmHg and/or diastolic BP ≥ 100 mmHg; impaired liver function defined as ALAT or ASAT ≥ 2.5 times upper limit of normal; severe renal impairment defined as glomerular filtration rate < 30 mL/min/1.73 m2; proliferative retinopathy or maculopathy requiring acute treatment according to the investigator verification by fundoscopy or fundus photography performed within 12 weeks Diagnostic criteria: clinically diagnosed Number of study centres: 90
Interventions	Intervention(s): degludec Comparator(s): glargine Duration of intervention: 32 weeks Duration of follow‐up: 32 weeks Run‐in period: none
Outcomes	Reported outcome(s) in full text of publication: hypoglycaemia, safety, at cross‐over: HbA1c and quality of life
Study registration	Trial identifier: NCT02034513; NN1250‐3995; WHO ID: U1111‐1129‐9668; EudraCT number: 2012‐001930‐32 Study terminated early: no
Publication details	Language of publication: English Funding: commercial funding (Novo Nordisk) Publication status: peer‐reviewed journal
Stated aim of study	Quote: "To determine whether insulin degludec is noninferior or superior to insulin glargine U100 in reducing the rate of symptomatic hypoglycemic episodes"
Notes	The study had a cross‐over design ‐ each intervention period was 32 weeks before cross‐over. Main analyses of the study were performed in the last 16 weeks of each cross‐over period: weeks during the maintenance period (weeks 16‐32 and 48‐64) Study also reported in FDA 2015 report; this trial is described as ongoing and no additional data could be retrieved (FDA 2015)