Use of acarbose or bedtime insulin after failure of treatment with conventional oral antidiabetics - A one-year randomised clinical trial

Objective: Addition of bedtime insulin to existing treatment with oral anti diabetic drugs (OAD) is now common practice in the management of OAD failur e. However. information on adding acarbose to treat secondary OAD failure i s limited. We evaluated the efficacy of acarbose in the treatment of second ary OAD failure and compared it directly with bedtime insulin. Design and Setting: Randomised parallel-group study performed in Hong Kong. Patients and Participants: 57 Chinese patients with type 2 diabetes and sec ondary OAD failure. Mean age and body mass index (+/- SD) were 58.8 +/- 11. 2 years and 24.6 +/- 3.6 kg/m(2), respectively. Methods: Patients were randomised to received acarbose or insulin in additi on to their original OAD regimen, and were followed up at 12, 24, 36 and 52 weeks. Dosages of both drugs were adjusted if a glycated haemoglobin (HbA( 1c)) level of <8.5% was not achieved. Results: The primary end-point was improvement in HbA Ic. Insulin, as compa red with acarbose. gave a greater reduction in fasting plasma glucose level s (-4.8% vs -34.5%, p = 0.007, and -6.7% vs -34.8%, p = 0.015, at 6 and 12 months, respectively). The improvements at 12 months in 2-hour blood glucos e (acarbose group, 17.0 +/- 4.2 to 13.5 +/- 1.8 mmol/L; insulin group, 17.2 +/- 5.4 to 10,9 +/- 4.4 mmol/L) and HbA(1c) (acarbose group, 10.6 +/- 1.7% to 9.1 +/- 1.5%; insulin group, 10.0 +/- 0.8% to 8.3 +/- 1.2%) were simila r between the two groups. Patients given insulin showed significant bodywei ght gain 3 and 6 months after treatment, but not after 1 year of treatment. Patients on acarbose maintained a stable bodyweight during the treatment p eriod. Of the 27 patients receiving acarbose, five developed significant ad verse effects, namely flatulence, diarrhoea and abdominal colic. No patient s in the insulin-treated group developed similar clinically significant adv erse effects (p = 0.008). Conclusion: In Chinese patients with type 2 diabetes with secondary OAD fai lure. addition of acarbose provides a reasonable alternative, at least in t he short term, in patients who are unable or unwilling to use insulin treat ment.