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Insulin analogues reduce the risk of hypoglycaemia compared with human insulin in patients with type 1 diabetes (T1D) and minor hypoglycaemia problems.
Major hypoglycaemia was reported by 5% of all patients, minor hypoglycaemia increased with diabetes duration (25.4 30.3%); overall hypoglycaemia rate was 6.7 events/patient/year. Complications increased with diabetes duration; the most reported were hypertension (40.6 71.0%) and hyperlipidaemia (39.4 56.6%).
The estimated average levels of blood/plasma glucose during events seemed to be approximately 1 mmol/l lower during major versus minor hypoglycaemia (not statistically tested) with no significant difference between treatments (Table 4).
Minor hypoglycaemia occurred in < 10% of subjects for any treatment.
There appears to be some variation in reported rates of minor hypoglycaemia.
Major and minor hypoglycaemia rates were ≤0.5 episodes per patient-year in both age groups.
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Bolen et al. combined results for minor and major hypoglycaemia, whereas our aim was only to estimate the average annual rate of severe hypoglycaemia.
9 Both incretin-based drug classes improve glycaemic control in patients with type 2 diabetes, with minor risk of hypoglycaemia in clinical practice.
In agreement with most [11], [20], [21], [23], but not all [22] previous studies, we found no significant difference between treatments in the incidence of minor or overall major hypoglycaemia.
Hence, although we recruited patients with preserved hypoglycaemic awareness and there was no significant difference in the incidence of reporting minor or overall major hypoglycaemia at enrolment or after one year, major hypoglycaemic events were potentially more serious with metformin than with placebo.
We did not assess our patients for minor brain dysfunction after hypoglycaemia.
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