PMID- 29272062 OWN - NLM STAT- MEDLINE DCOM- 20190114 LR - 20221207 IS - 1463-1326 (Electronic) IS - 1462-8902 (Linking) VI - 20 IP - 5 DP - 2018 May TI - 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. PG - 1121-1130 LID - 10.1111/dom.13196 [doi] AB - 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. CI - (c) 2017 John Wiley & Sons Ltd. FAU - Chon, Suk AU - Chon S AUID- ORCID: 0000-0001-5921-2989 AD - Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea. FAU - Rhee, Sang Youl AU - Rhee SY AD - Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea. FAU - Ahn, Kyu Jeung AU - Ahn KJ AD - Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea. FAU - Baik, Sei Hyun AU - Baik SH AD - Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. FAU - Park, Yongsoo AU - Park Y AD - Department of Internal Medicine, Hanyang University College of Medicine, Guri, Korea. FAU - Nam, Moon Suk AU - Nam MS AD - Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea. FAU - Lee, Kwan Woo AU - Lee KW AD - Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea. FAU - Yoo, Soon Jib AU - Yoo SJ AD - Department of Endocrinology and Metabolism, Bucheon St. Mary's Hospital, The Catholic University of Korea, Bucheon, Korea. FAU - Koh, Gwanpyo AU - Koh G AD - Department of Internal Medicine, Jeju National University School of Medicine, Jeju, Korea. FAU - Lee, Dae Ho AU - Lee DH AD - Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea. FAU - Kim, Young Seol AU - Kim YS AD - Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea. FAU - Woo, Jeong-Taek AU - Woo JT AUID- ORCID: 0000-0001-9201-0713 AD - Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea. CN - KIIT study investigators LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20180122 PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Insulin) RN - 0 (Sulfonylurea Compounds) RN - 0 (hemoglobin A1c protein, human) RN - 6KY687524K (glimepiride) RN - 9100L32L2N (Metformin) SB - IM MH - Adult MH - Diabetes Mellitus, Type 2/blood/*diagnosis/metabolism MH - Drug Resistance, Multiple MH - Drug Therapy, Combination/adverse effects MH - Female MH - Follow-Up Studies MH - Glycated Hemoglobin/analysis MH - Hospitals, University MH - Humans MH - Hyperglycemia/*prevention & control MH - Hypoglycemia/*prevention & control MH - Hypoglycemic Agents/administration & dosage/adverse effects/*therapeutic use MH - Insulin/administration & dosage/adverse effects/*therapeutic use MH - Insulin Resistance MH - Insulin Secretion/drug effects MH - Insulin-Secreting Cells/drug effects/metabolism MH - Male MH - Metformin/administration & dosage/adverse effects/*therapeutic use MH - Middle Aged MH - Outpatient Clinics, Hospital MH - Republic of Korea MH - Sulfonylurea Compounds/administration & dosage/adverse effects/*therapeutic use OTO - NOTNLM OT - Korea OT - blood glucose OT - combination OT - drug therapy OT - glimepiride OT - hyperglycaemia OT - hypoglycaemic agents OT - insulin glargine OT - insulin glulisine OT - type 2 diabetes mellitus EDAT- 2017/12/23 06:00 MHDA- 2019/01/15 06:00 CRDT- 2017/12/23 06:00 PHST- 2017/09/22 00:00 [received] PHST- 2017/12/11 00:00 [revised] PHST- 2017/12/18 00:00 [accepted] PHST- 2017/12/23 06:00 [pubmed] PHST- 2019/01/15 06:00 [medline] PHST- 2017/12/23 06:00 [entrez] AID - 10.1111/dom.13196 [doi] PST - ppublish SO - Diabetes Obes Metab. 2018 May;20(5):1121-1130. doi: 10.1111/dom.13196. Epub 2018 Jan 22.