Mohamed Hassanein1, Akram Salim Echtay2, Rachid Malek3, Mahomed Omar4, Shehla Sajid Shaikh5, Magnus Ekelund6, Kadriye Kaplan7, Nor Azmi Kamaruddin8. 1. Endocrine Department, Dubai Hospital, Dubai Health Authority, Dubai, United Arab Emirates. Electronic address: mhassanein148@hotmail.com. 2. Internal Medicine Department, Head Division of Endocrinology, Rafic Hariri University Hospital, Bir Hassan, Jinah, POB: 5244, 2833-7401, Beirut, Lebanon. Electronic address: akramechtay2@gmail.com. 3. Department of Internal Medicine, CHU Setif, 19000, Algeria. Electronic address: rmalekdz@gmail.com. 4. Department of Diabetes and Endocrinology, University of KwaZulu Natal, Durban, South Africa. Electronic address: momars@telkomsa.net. 5. Department of Endocrinology, Prince Aly Khan Hospital, Mumbai, India. Electronic address: drshehla@rediffmail.com. 6. Novo Nordisk A/S, Vandtaarnsvej 114, DK 2860, Søborg, Denmark. Electronic address: muek@novonordisk.com. 7. Novo Nordisk A/S, Vandtaarnsvej 114, DK 2860, Søborg, Denmark. Electronic address: kdka@novonordisk.com. 8. UKM Medical Centre, National University of Malaysia, Jalan Yaacob Latif, Bandar Tun Razal, Cheras Kuala Lumpur, Malaysia. Electronic address: dr.nor.azmi@gmail.com.
Abstract
AIMS: To compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) and biphasic insulin aspart 30 (BIAsp 30) before, during and after Ramadan in patients with type 2 diabetes mellitus (T2DM) who fasted during Ramadan. METHODS: In this multinational, randomised, treat-to-target trial, patients with T2DM who intended to fast and were on basal, pre- or self-mixed insulin ± oral antidiabetic drugs for ≥90 days were randomised (1:1) to IDegAsp twice daily (BID) or BIAsp 30 BID. Treatment period included pre-Ramadan treatment initiation (with insulin titration for 8-20 weeks), Ramadan (4 weeks) and post-Ramadan (4 weeks). Insulin doses were reduced by 30-50% for the pre-dawn meal (suhur) on the first day of Ramadan, and readjusted to the pre-Ramadan levels at the end of Ramadan. Hypoglycaemia was analysed as overall (severe or plasma glucose <3.1 mmol/L [56 mg/dL]), nocturnal (00:01-05:59) or severe (requiring assistance of another person). RESULTS: During the treatment period, IDegAsp (n = 131) had significantly lower overall and nocturnal hypoglycaemia rates with similar glycaemic efficacy, versus BIAsp 30 (n = 132). During Ramadan, despite achieving significantly lower pre-iftar (meal at sunset) self-measured plasma glucose (estimated treatment difference: -0.54 mmol/L [-1.02; -0.07]95% CI, p = .0247; post hoc) with similar overall glycaemic efficacy, IDegAsp showed significantly lower overall and nocturnal hypoglycaemia rates versus BIAsp 30. CONCLUSIONS: IDegAsp is a suitable therapeutic agent for patients who need insulin for sustained glucose control before, during and after Ramadan fasting, with a significantly lower risk of hypoglycaemia, versus BIAsp 30, an existing premixed insulin analogue.
RCT Entities:
AIMS: To compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) and biphasic insulin aspart 30 (BIAsp 30) before, during and after Ramadan in patients with type 2 diabetes mellitus (T2DM) who fasted during Ramadan. METHODS: In this multinational, randomised, treat-to-target trial, patients with T2DM who intended to fast and were on basal, pre- or self-mixed insulin ± oral antidiabetic drugs for ≥90 days were randomised (1:1) to IDegAsp twice daily (BID) or BIAsp 30 BID. Treatment period included pre-Ramadan treatment initiation (with insulin titration for 8-20 weeks), Ramadan (4 weeks) and post-Ramadan (4 weeks). Insulin doses were reduced by 30-50% for the pre-dawn meal (suhur) on the first day of Ramadan, and readjusted to the pre-Ramadan levels at the end of Ramadan. Hypoglycaemia was analysed as overall (severe or plasma glucose <3.1 mmol/L [56 mg/dL]), nocturnal (00:01-05:59) or severe (requiring assistance of another person). RESULTS: During the treatment period, IDegAsp (n = 131) had significantly lower overall and nocturnal hypoglycaemia rates with similar glycaemic efficacy, versus BIAsp 30 (n = 132). During Ramadan, despite achieving significantly lower pre-iftar (meal at sunset) self-measured plasma glucose (estimated treatment difference: -0.54 mmol/L [-1.02; -0.07]95% CI, p = .0247; post hoc) with similar overall glycaemic efficacy, IDegAsp showed significantly lower overall and nocturnal hypoglycaemia rates versus BIAsp 30. CONCLUSIONS: IDegAsp is a suitable therapeutic agent for patients who need insulin for sustained glucose control before, during and after Ramadan fasting, with a significantly lower risk of hypoglycaemia, versus BIAsp 30, an existing premixed insulin analogue.
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