Suk Chon1, Sang Youl Rhee1, Kyu Jeung Ahn1, Sei Hyun Baik2, Yongsoo Park3, Moon Suk Nam4, Kwan Woo Lee5, Soon Jib Yoo6, Gwanpyo Koh7, Dae Ho Lee8, Young Seol Kim1, Jeong-Taek Woo1. 1. Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea. 2. Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. 3. Department of Internal Medicine, Hanyang University College of Medicine, Guri, Korea. 4. Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea. 5. Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea. 6. Department of Endocrinology and Metabolism, Bucheon St. Mary's Hospital, The Catholic University of Korea, Bucheon, Korea. 7. Department of Internal Medicine, Jeju National University School of Medicine, Jeju, Korea. 8. Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.
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 β-cell function in people with type 2 diabetes mellitus (T2DM). METHODS:Newly diagnosed drug-naïve 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 β-cell function and glycaemic control over the long term, without serious adverse events.
RCT Entities:
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 β-cell function in people with type 2 diabetes mellitus (T2DM). METHODS: Newly diagnosed drug-naïve patients with T2DM from 8 outpatientdiabetes 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 β-cell function and glycaemic control over the long term, without serious adverse events.
Authors: Kristina M Utzschneider; Mark T Tripputi; Alexandra Kozedub; Elena Barengolts; Sonia Caprio; Melanie Cree-Green; Sharon L Edelstein; Laure El Ghormli; Tamara S Hannon; Kieren J Mather; Jerry Palmer; Kristen J Nadeau Journal: Diabetes Res Clin Pract Date: 2021-07-15 Impact factor: 8.180