Insulin Treatment of Fasting or Postprandial Glucose in Type 2 Diabetes. Does It Matter? The South Danish Diabetes Study (SDDS)

Henriksen, Jan Erik; Gram, Jeppe; Beck-Nielsen, Henning
June 2007
Diabetes;Jun2007 Supplement 1, Vol. 56, pA51
Academic Journal
Insulin treatment of fasting hyperglycaemia using bedtime NPH insulin is often used in Type 2 diabetes whereas treatment of postprandial hyperglycaemia has not gained much impact. This investigator driven, randomised, intention to treat (ITT), and treat to target study compared the effect of NHP insulin given at bedtime with insulin Aspart alone given before the 3 main meals during 2 yrs. Beside insulin all patients received double blinded treatment with placebo or metformin or rosiglitazone or both, giving a total of 8 subgroups (factorial design). Patients treated with NPH insulin adjusted insulin dose based on measured fasting glucose concentrations and patients treated with Aspart based on glucose measured 1 1/2 hours following the meals. In total 371 patients with type 2 diabetes for at least 2 years and not sufficiently controlled on oral antidiabetic treatment and/or insulin were included. Age 56.3 ± 8.4yr (mean ± SD), BMI 33.9 ± 5.7 kg/m2, baseline HbA1c 8.6 ± 1.2%. 311 patients completed the study but data analysis is based on 369 ITT subjects. Overall, following 2 years treatment, Hba1c was significantly lower in patients treated with Aspart as compared to NPH insulin (-0,41%, (-0.6 to -0.22, 95% CI), p<0.001). Moreover, metformin treatment was associated with a decrease in Hba1c as compared to placebo (-0.60%, (-0.79 to -0.41), p<0.001) as was rosiglitazone (-0.55%, (-0.74 to -0.36), p<0.001). In subgroup analysis after 2 years treatment HbA1c was 8.3±1.3% in the NPH alone group, 7.8±1.1% in the Aspart alone group and in the two triple therapy groups treated with either Aspart or NPH insulin together with both metformin and rosiglitazone 7.0±1.0 and 6.8±0.9% respectively. Body weight increased more using insulin Aspart than using NPH insulin (5.9 ± 6.1 vs 4.7 ± 5.7 kg, p<0.01) whereas metformin versus placebo was associated with a lower increase (4.1 ± 5.5 vs 6.6 ± 6.0 kg, p<0.001) and rosiglitazone versus placebo with a greater increase (6.6 ± 6.4 vs 4.1 ± 5.1 kg, p<0.001). Clinical congestive hearth failure did not occur more often in patients treated with rosiglitazone. In conclusion treatment with insulin Aspart alone at mealtime is associated with a lower HbA1c as compared to treatment with NHP insulin at bedtime. Further addition of metformin and/or rosiglitazone to insulin treatment decreases HbA1c by approximately 0.6% each. Optimal treatment of Type 2 diabetes patients is best obtained by triple therapy combining insulin with metformin and rosiglitazone.


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