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. Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.
AIM:Aim of the study was to compare outcomes of pregnancy in gestational diabetes mellitus (GDM) treated with metformin, insulin, or diet.MATERIAL AND METHODS:The study included 48 women with GDM treated with metformin, 101 with insulin, and 200 women on a diet from the Outpatient Department of Endocrinology and University Clinic of Obstetrics and Gynecology in Skopje.RESULTS:The groups were comparable in age, smoking cigarettes and positive family history of diabetes. Mean glycosylated haemoglobin (HbA1c) at 37 gestation week, mean fasting, postprandial glycaemia, and gestational age at delivery were lower in diet and metformin than insulin group. No differences in mode of delivery were observed between the metformin and insulin group. Women in metformin group had a significantly lower incidence of LGA newborns than diet and insulin groups. The percent of SGA new-borns was higher in insulin group than diet and metformin groups. The incidence of neonatal hypoglycemia was statistically significantly higher in the insulin group than in the metformin and diet group.CONCLUSION:Metformin in women with GDM can improve maternal and neonatal outcomes compared with those treated with diet or insulin.
Insulin pump therapy together with constant or intermittent CGM can improve diabetes control and pregnancy outcome in type 1 diabetes. The quality of the glucose profile at conception was the important factor for pregnancy outcome.
Twice daily BIAsp30 reduced postprandial glucose exposure to a significantly greater extent than NPH insulin and was at least as effective at reducing HbA1c in patients with type 2 diabetes. Both insulins were well tolerated. In patients poorly controlled on OHAs or NPH alone, glycaemic control can be improved by switching to twice daily BIAsp30, without increasing hypoglycaemic risk.
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