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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

Change in mean glycated haemoglobin (HbA1c) over time. Detemir, black circles; Neutral Protamine Hagedorn, white circles.
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fig02: Change in mean glycated haemoglobin (HbA1c) over time. Detemir, black circles; Neutral Protamine Hagedorn, white circles.

Mentions: HbA1c decreased by 0.94% with detemir and by 0.72% with NPH during the trial; glycaemic control was superior with detemir after 24 months, with a mean difference (detemir—NPH) of −0.22% points (Table 3). The difference in HbA1c between the two treatment groups was most pronounced during the last 6 months of the trial (Fig. 2). FPGlab also decreased to a larger extent with detemir than with NPH, with reductions of 3.01 mmol/l vs. 1.93 mmol/l (P = 0.019) (Table 3). Within-patient variation in self-measured FPG was lower with detemir than with NPH (sd 2.18 mmol/l vs. 2.52 mmol/l; P < 0.001), while no statistically significant difference was found in pre-evening meal PG variation (sd 2.50 mmol/l vs. 2.46 mmol/l; P = NS). Self-measured nine-point PG concentrations were generally reduced in both groups at all times of the day, but the shape of these profiles could not be considered parallel after 24 months of treatment (P = 0.004). The main differences between treatments were related to higher mean PG levels pre-evening meal and lower mean concentrations before breakfast with detemir compared to NPH.


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)

Change in mean glycated haemoglobin (HbA1c) over time. Detemir, black circles; Neutral Protamine Hagedorn, white circles.
© Copyright Policy
Related In: Results  -  Collection

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

fig02: Change in mean glycated haemoglobin (HbA1c) over time. Detemir, black circles; Neutral Protamine Hagedorn, white circles.
Mentions: HbA1c decreased by 0.94% with detemir and by 0.72% with NPH during the trial; glycaemic control was superior with detemir after 24 months, with a mean difference (detemir—NPH) of −0.22% points (Table 3). The difference in HbA1c between the two treatment groups was most pronounced during the last 6 months of the trial (Fig. 2). FPGlab also decreased to a larger extent with detemir than with NPH, with reductions of 3.01 mmol/l vs. 1.93 mmol/l (P = 0.019) (Table 3). Within-patient variation in self-measured FPG was lower with detemir than with NPH (sd 2.18 mmol/l vs. 2.52 mmol/l; P < 0.001), while no statistically significant difference was found in pre-evening meal PG variation (sd 2.50 mmol/l vs. 2.46 mmol/l; P = NS). Self-measured nine-point PG concentrations were generally reduced in both groups at all times of the day, but the shape of these profiles could not be considered parallel after 24 months of treatment (P = 0.004). The main differences between treatments were related to higher mean PG levels pre-evening meal and lower mean concentrations before breakfast with detemir compared to NPH.

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