Effect of Insulin Detemir (Levemir®) on Risk of Hypoglycaemia and Glycaemic Parameters: Experience from Real Life Practice in Indonesian Patients with Diabetes Mellitus
Objective. To evaluate the safety and efficacy of insulin detemir in patients with diabetes mellitus in Indonesia.
Methods. This was a multi-centre, prospective, 12-week observational study in patients with diabetes mellitus conducted in Indonesia.
Results. A non-randomized sample of 1290 patients with diabetes mellitus in which most of them were type 2 diabetes (1285 patients, 57.4% males, mean age 54.1 ± 9.0 years, mean BMI 23.5 ± 4.1 kg/m2, mean duration of diabetes 6.5 ± 4.9 years) were recruited from 121 sites. No serious adverse drug reactions (SADRs) including major hypoglycaemic episodes were reported at 12 weeks. The rate of total and major hypoglycaemic episodes decreased from 0.0248 to 0.0031 episodes/patient years and from 0.0022 to 0 episodes/patient years from baseline to 12 weeks, respectively. Treatment with insulin detemir was associated with a reduction in HbA1c of ‑2.0%-point (95% CI, ‑2.13 to ‑1.93) from baseline to 12 weeks. Insulin detemir also improved FPG. A slight increase of 0.12 kg (95% CI, ‑0.05 to 0.29) in body weight was observed from baseline to 12 weeks.
Conclusions. 12-week treatment with insulin detemir was safe and well-tolerated in Indonesian patients with type 2 diabetes. It improved glycaemic control, decreased the risk of hypoglycaemia and was relatively weight neutral.
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