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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.

Bartley PC, Bogoev M, Larsen J, Philotheou A - Diabet. Med. (2008)

Bottom Line: 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.The overall safety profile was similar in the two groups and treatment with detemir did not result in any unexpected findings.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, University of Queensland, Australia. p.bartley@uq.edu.au

ABSTRACT

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 < or = 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) < or = 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.

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Related in: MedlinePlus

Patient disposition.
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fig01: Patient disposition.

Mentions: Of the 497 patients randomized, 495 were exposed and approximately 85% completed the trial (Fig. 1). A slightly higher proportion of patients on detemir withdrew because of adverse events, while withdrawal because of non-compliance was more common in the NPH group. A fairly large proportion of patients in both arms withdrew for ‘other’ unspecified reasons. With the exception of one patient treated with detemir, who withdrew because of concerns of hypoglycaemia, these were all non-related to trial products.


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.

Bartley PC, Bogoev M, Larsen J, Philotheou A - Diabet. Med. (2008)

Patient disposition.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2327220&req=5

fig01: Patient disposition.
Mentions: Of the 497 patients randomized, 495 were exposed and approximately 85% completed the trial (Fig. 1). A slightly higher proportion of patients on detemir withdrew because of adverse events, while withdrawal because of non-compliance was more common in the NPH group. A fairly large proportion of patients in both arms withdrew for ‘other’ unspecified reasons. With the exception of one patient treated with detemir, who withdrew because of concerns of hypoglycaemia, these were all non-related to trial products.

Bottom Line: 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.The overall safety profile was similar in the two groups and treatment with detemir did not result in any unexpected findings.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, University of Queensland, Australia. p.bartley@uq.edu.au

ABSTRACT

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 < or = 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) < or = 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.

Show MeSH
Related in: MedlinePlus