The effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in adults with type 1 diabetes and high risk of nocturnal severe hypoglycaemia (the HypoDeg trial): study rationale and design.
Rikke Mette AgesenAmra Ciric AlibegovicHenrik Ullits AndersenHenning Beck-NielsenPeter GustenhoffTroels Krarup HansenChristoffer HedetoftTonny JensenClaus Bogh JuhlSusanne Søgaard LercheKirsten NørgaardHans-Henrik ParvingLise TarnowBirger ThorsteinssonUlrik Pedersen-BjergaardPublished in: BMC endocrine disorders (2019)
In contrast to most other insulin studies the HypoDeg trial includes only patients at high risk of hypoglycaemia. The HypoDeg trial will compare treatment with insulin degludec to insulin glargine U100 in terms of risk of nocturnal hypoglycaemic episodes in patients with type 1 diabetes with the greatest potential to benefit from near-physiological insulin replacement therapy. www.clinicaltrials.gov : NCT02192450.
Keyphrases
- type diabetes
- glycemic control
- replacement therapy
- blood pressure
- study protocol
- obstructive sleep apnea
- phase iii
- clinical trial
- phase ii
- sleep apnea
- insulin resistance
- sleep quality
- randomized controlled trial
- smoking cessation
- computed tomography
- climate change
- adipose tissue
- metabolic syndrome
- skeletal muscle
- human health
- placebo controlled
- case control
- drug induced