Long-term effects on glycaemic control and beta-cell preservation of early intensive treatment in patients with newly diagnosed type 2 diabetes: A multicentre randomized trial
- Authors
- Chon, Suk; Rhee, Sang Youl; Ahn, Kyu Jeung; Baik, Sei Hyun; Park, Yongsoo; Nam, Moon Suk; Lee, Kwan Woo; Yoo, Soon Jib; Koh, Gwanpyo; Lee, Dae Ho; Kim, Young Seol; Woo, Jeong-Taek
- Issue Date
- 5월-2018
- Publisher
- WILEY
- Keywords
- blood glucose; combination; drug therapy; glimepiride; hyperglycaemia; hypoglycaemic agents; insulin glargine; insulin glulisine; Korea; type 2 diabetes mellitus
- Citation
- DIABETES OBESITY & METABOLISM, v.20, no.5, pp.1121 - 1130
- Indexed
- SCIE
SCOPUS
- Journal Title
- DIABETES OBESITY & METABOLISM
- Volume
- 20
- Number
- 5
- Start Page
- 1121
- End Page
- 1130
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/75655
- DOI
- 10.1111/dom.13196
- ISSN
- 1462-8902
- Abstract
- Aim: To determine the effects of early intensive glycaemic control with intensive insulin treatment (IIT) or initial combined oral antidiabetic drug (COAD) therapy on long-term glycaemic control and the preservation of beta-cell function in people with type 2 diabetes mellitus (T2DM). Methods: Newly diagnosed drug-naive patients with T2DM from 8 outpatient diabetes centres were randomized to receive either IIT (n=50; glargine/glulisine) or COAD (n=47; glimepiride/ metformin) as intensive treatment until the termination criteria to ensure euglycaemia were met. After intensive treatment, the patients completed a follow-up period with either lifestyle modification (LSM) alone or rescue therapy to maintain target glycated haemoglobin levels of <7% (53 mmol/mol) up to week 104. The primary outcomes were analysed after excluding participants who were anti-glutamic acid decarboxylase autoantibody-positive. Results: Both intensive treatment methods were effective for short-term glycaemic control, but improvements in the disposition index (DI) were significantly greater in the IIT group than in the COAD group (P=.021). During the follow-up period after intensive treatment, the two groups significantly differed in rescue method regarding the maintenance of comparable levels of glycaemic control (P=.010) and more participants who received IIT exhibited well-controlled glycaemia with LSM alone. Additionally, the IIT group maintained a higher DI than the COAD group during the follow-up period. Cox regression analysis showed that the IIT method was associated with a 52.5% lower risk of failing to maintain drug-free glycaemic remission compared with the COAD method (P=.015). Conclusions: The findings indicate that outpatient clinic-based IIT to ensure euglycaemia in newly diagnosed patients with T2DM might be an effective initial therapeutic option for improvements in beta-cell function and glycaemic control over the long term, without serious adverse events.
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