Omar Ma

Original paper: Efficacy and safety analysis of insulin degludec/insulin aspart compared with biphasic insulin aspart 30: A phase 3, multicentre, international, open-label, randomised, treat-to-target trial in patients with type 2 diabetes fasting during Ramadan

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.

Incidence of hypoglycaemia among insulin-treated patients with type 1 or type 2 diabetes mellitus: South African cohort of International Operations Hypoglycaemia Assessment Tool (IO HAT) study

Objectives: To assess the incidence and rates of hypoglycaemia in patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) in the South African cohort of the International Operations Hypoglycaemia Assessment Tool (IO HAT) study. Methods: Patients diagnosed with either T1DM or T2DM, aged ≥ 18 years and treated with insulin for > 12 months, completed self-assessment questionnaires to record demography, treatment information and hypoglycaemia during a 6-month retrospective and 4-week prospective periods (ClinicalTrials.gov: NCT02306681). Results: In T1DM 76.2% (95% confidence interval [CI] 69.1%, 82.3%) of patients reported hypoglycaemia in the retrospective period and 98.2% (95% CI 94.7%, 99.6%) in the prospective period. The corresponding figures for patients with T2DM were 52.2% (95% CI 48.6%, 55.9%) and 90.1% (95% CI 87.7%, 92.3%), respectively. Rates of any and severe hypoglycaemia, respectively were T1DM 90.7 events per patient year (PPY) (95% CI 85.5, 96.1) and 8.8 events PPY (95% CI 7.2, 10.6) and T2DM 45.7 events PPY (95% CI 43.9, 47.5) and 8.9 events PPY (95% CI 8.1, 9.8) during the prospective period. The rates of hypoglycaemia were independent of glycated haemoglobin levels. Conclusions: This is the first patient dataset of self-reported hypoglycaemia in South Africa; results showed that hypoglycaemia is under-reported.