Use of Acarbose or Bedtime Insulin after Failure of Treatment with Conventional Oral Antidiabetics: A One-Year Randomised Clinical Trial

Authors: Ko G.T.C.1; Tsang C-C.1; Ng C-W.1; Wai H.P.S.2; Kan E.C.Y.1

Source: Clinical Drug Investigation, Volume 21, Number 6, 1 June 2001 , pp. 401-408(8)

Publisher: Adis International

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Abstract:

Objective: Addition of bedtime insulin to existing treatment with oral antidiabetic drugs (OAD) is now common practice in the management of OAD failure. However, information on adding acarbose to treat secondary OAD failure is limited. We evaluated the efficacy of acarbose in the treatment of secondary 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 secondary OAD failure. Mean age and body mass index (± SD) were 58.8 ± 11.2 years and 24.6 ± 3.6 kg/m, respectively.

Methods: Patients were randomised to received acarbose or insulin in addition 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) level of <8.5% was not achieved.

Results: The primary end-point was improvement in HbA. Insulin, as compared with acarbose, gave a greater reduction in fasting plasma glucose levels (-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 glucose (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 (acarbose group, 10.6 ± 1.7% to 9.1 ± 1.5%; insulin group, 10.0 ± 0.8% to 8.3 ± 1.2%) were similar between the two groups. Patients given insulin showed significant bodyweight gain 3 and 6 months after treatment, but not after 1 year of treatment. Patients on acarbose maintained a stable bodyweight during the treatment period. Of the 27 patients receiving acarbose, five developed significant adverse effects, namely flatulence, diarrhoea and abdominal colic. No patients in the insulin-treated group developed similar clinically significant adverse effects (p = 0.008).

Conclusion: In Chinese patients with type 2 diabetes with secondary OAD failure, addition of acarbose provides a reasonable alternative, at least in the short term, in patients who are unable or unwilling to use insulin treatment.

Keywords: Acarbose, therapeutic use; Antihyperglycaemics, therapeutic use; Insulin, therapeutic use; Type 2 diabetes mellitus, treatment

Document Type: Original article

Affiliations: 1: Department of Medicine, Alice Ho Miu Ling Nethersole Hospital, Hong Kong 2: Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong

Publication date: 2001-06-01

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