Incidence and severity of hypoglycaemia in type 2 diabetes by treatment regimen: A UK multisite 12‐month prospective observational study

Abstract

Aims To determine the incidence and severity of self‐reported hypoglycaemia in a primary care population with type 2 diabetes. The study also aimed to compare incidence by treatment regimen. Materials and methods A prospective observational study in 17 centres throughout the UK was conducted. Recruitment was based on treatment regimen (metformin alone, sulphonylurea‐, insulin‐ or incretin‐based therapy). Participants were asked to keep a blood glucose diary and self‐report hypoglycaemia episodes [non‐severe (self‐treated) and severe (requiring external help)] over a 12‐month period. Results Three hundred and twenty‐five participants were enrolled, of whom 274 (84%) returned ≥1 monthly diaries. Overall, 39% reported experiencing hypoglycaemia; 32% recorded ≥1 symptomatic, 36% ≥1 non‐severe, and 7% ≥1 severe episodes. By treatment, incidence (events per person/year) for any hypoglycaemia type was 4.39 for insulin, 2.34 for sulphonylurea, 0.76 for metformin, and 0.56 for incretin‐based therapy. Compared with metformin, risk of non‐severe hypoglycaemia was ~3 times higher for participants on sulphonylureas and > 5 times higher for those on insulin [incidence rate ratio (IRR) 3.02 (1.76‐5.18), P < 0.001, and IRR 5.96 (3.48‐10.2), P < 0.001, respectively]. For severe episodes, the incidence for sulphonylurea (0.09) was similar to metformin (0.07) and incretin‐based therapy (0.07); for insulin the risk remained almost 5 times higher than metformin [incidence 0.32; IRR 4.55 (1.28‐16.20), P = 0.019]. Conclusions Hypoglycaemia represents a substantial burden for people with type 2 diabetes. Sulphonylureas and insulin are both associated with a risk of reported non‐severe hypoglycaemia, but only insulin with severe episodes. This suggests the importance of the continued use of sulphonylureas in appropriate patients with type 2 diabetes.

Management of Type 2 Diabetes in Developing Countries: Balancing Optimal Glycaemic Control and Outcomes with Affordability and Accessibility to Treatment

“…Generalizations for the efficacy and safety of sulfonylureas as a class should, therefore, be avoided [64]. Additionally, despite previous data, a recent prospective study showed no increased risk of severe hypoglycaemia with sulfonylureas [65].…”

Hypoglycaemia and its management in primary care setting

“…Clinical stratification . Hypoglycaemia risk is three‐times higher in patients on insulin secretagogues (sulphonylurea) and five‐times higher for those on insulin 44 …”

“…Two types of anti‐diabetic agents are associated with hypoglycaemia—insulin secretagogues (ie, sulphonylureas) and insulin. As shown in Table 2, intensive treatment mainly with supplemental treatment with insulin and SU (ACCORD, ADVANCE, and VADT) shows that the risk of hypoglycaemic events are about 2‐ to 3‐fold higher than compared to standard treatment compared to newer glucose‐lowering agents 44, 109 . Within the last decade newer anti‐diabetic drugs have been developed and marketed with minimal if any risk of hypoglycaemia when used as monotherapy.…”

Role of Gliclazide MR in the Management of Type 2 Diabetes: Report of a Symposium on Real-World Evidence and New Perspectives

“…Based on the data from randomised trials, at least 232 patients would need to be treated with a sulfonylurea to cause one severe hypoglycaemic event (number needed to harm [NNH]), and the NNH for gliclazide MR specifically is 333 [ 41 , 42 , 54 – 56 ]. The low risk of symptomatic hypoglycaemia is supported by data from a prospective observational study of primary care T2DM patients in the UK [ 58 ]. This study showed a risk of hypoglycaemia (blood glucose < 3.0 mmol/L) of 0.12 per person-year with sulfonylureas, similar to the rate with incretin-based therapy (0.04 per person-year) and much lower than the rate with insulin (1.03 per person-year) [ 58 ].…”