Premium
Long‐term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat‐to‐target basal–bolus regimen with insulin aspart at meals: a 2‐year, randomized, controlled trial
Author(s) -
Bartley P. C.,
Bogoev M.,
Larsen J.,
Philotheou A.
Publication year - 2008
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2007.02407.x
Subject(s) - insulin detemir , medicine , insulin aspart , nph insulin , endocrinology , protamine , type 2 diabetes , insulin , evening , type 1 diabetes , diabetes mellitus , gastroenterology , insulin glargine , heparin , physics , astronomy
Aims This 24‐month, multi‐national, open‐label, parallel group trial investigated the long‐term efficacy and safety of insulin detemir and Neutral Protamine Hagedorn insulin in combination with mealtime insulin aspart in patients with Type 1 diabetes using a treat‐to‐target concept. Methods Patients were randomized 2 : 1 to detemir ( n = 331) or NPH ( n = 166) groups. Basal insulin was initiated once daily (evening) and titrated individually based on self‐measured plasma glucose (PG) levels, aiming for pre‐breakfast and pre‐dinner targets ≤ 6.0 mmol/l. A second basal morning dose could be added according to pre‐defined criteria. Results After 24 months, superiority of glycated haemoglobin (HbA 1c ) was achieved with detemir compared to NPH (detemir 7.36%, NPH 7.58%, mean difference −0.22% points) [95% confidence interval (CI) −0.41 to −0.03%], with reductions of 0.94% and 0.72% points, respectively. Fasting PG (FPG lab ) was also lower with detemir (detemir 8.35 mmol/l, NPH 9.43 mmol/l; P = 0.019). Twenty‐two per cent of patients treated with detemir reached an HbA 1c ≤ 7.0% in the absence of confirmed hypoglycaemia during the last month of treatment vs. 13% on NPH ( P = 0.019). Risk of major and nocturnal hypoglycaemia was 69% and 46% lower with detemir than with NPH ( P < 0.001), respectively; patients treated with detemir gained less weight (detemir 1.7 kg, NPH 2.7 kg; P = 0.024). The overall safety profile was similar in the two groups and treatment with detemir did not result in any unexpected findings. Conclusions Long‐term treatment with the insulin analogues detemir + aspart was superior to NPH + aspart in reducing HbA 1c , with added benefits of less major and nocturnal hypoglycaemia and less weight gain.