TITLE

Adjunctive prandial or biphasic insulin for type 2 diabetes improved glycaemic control but increased hypoglycaemia and weight gain

AUTHOR(S)
Hollmand, R. R.
PUB. DATE
June 2008
SOURCE
Evidence Based Medicine;Jun2008, Vol. 13 Issue 3, p77
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
STUDY DESIGN Design: randomised controlled trial (Treating to Target in Type 2 Diabetes [4-T]). Allocation: concealed. Blinding: unblinded. STUDY QUESTION Setting: 58 centres in Ireland and the UK. Patients: 708 patients ⩾18 years of age (mean age 62 y, 64% men) who had type 2 diabetes for ⩾12 months (median 9 y), suboptimal glycaemic control (haemoglobin [Hb] A1c concentration 7.0-10.0%, mean 8.5%) while receiving maximally tolerated doses of metformin and sulphonylurea for ⩾4 months, body mass index ⩽40 (mean 30) kg/m², and no previous treatment with insulin. Exclusion criteria included thiazolidinedione or triple oral anti-diabetic therapy in ⩽6 months, severe retinopathy, plasma creatinine concentration ⩾130 µmol/l, cardiac disease, hepatic disease, and uncontrolled hypertension. Intervention: prandial insulin aspart thrice daily before meals (n = 239), biphasic insulin aspart 30 twice daily (n = 235), or basal insulin detemir once daily at bedtime (or twice daily if required) (n = 234). Starting doses of insulin were based on formulas involving fasting plasma glucose, weight, and height; changes in dose were based on self-reported glucose readings and episodes of hypoglycaernia. All patients continued to take their oral anti-diabetic medications. Patients with unacceptable hyperglycaemia after 24 weeks received a second type of insulin and discontinued sulphonylurea. Outcomes: HbA1c concentration, proportion of patients with HbA1c ⩽6.5%, hypoglycaemia, and weight gain. Follow-up period: 1 year. Patient follow-up: 94%. MAIN RESULTS The table shows the results at 1 year. 4.2% of patients in the prandial group, 8.9% in the biphasic group, and 17.9% in the basal group required a second type of insulin because of unacceptable hyperglycaemia (pÃ0.001). The mean numbers of symptomatic or severe hypoglycaemic episodes per patient per year were 12, 5.7, and 2.3, respectively. CONCLUSION In patients with type 2 diabetes poorly controlled on oral medications, the addition of prandial or biphasic insulin improved glycaemic control more than basal insulin but with more hypoglycaemia and weight gain.
ACCESSION #
32679414

 

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