Long-term effects on glycaemic control and β-cell preservation of early intensive treatment in patients with newly diagnosed type 2 diabetes: A multicentre randomized trial

Suk Chon, Sang Youl Rhee, Kyu Jeung Ahn, Sei-Hyun Baik, Yongsoo Park, Moon Suk Nam, Kwan Woo Lee, Soon Jib Yoo, Gwanpyo Koh, Dae Ho Lee, Young Seol Kim, Jeong Taek Woo

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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.

Original languageEnglish
JournalDiabetes, Obesity and Metabolism
DOIs
Publication statusAccepted/In press - 2018 Jan 1

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Type 2 Diabetes Mellitus
Multicenter Studies
Insulin
Hypoglycemic Agents
Therapeutics
glimepiride
Life Style
Glutamate Decarboxylase
Metformin
Glycosylated Hemoglobin A
Ambulatory Care Facilities
Pharmaceutical Preparations
Autoantibodies
Outpatients
Regression Analysis
Maintenance
Drug Therapy

Keywords

  • Blood glucose
  • Combination
  • Drug therapy
  • Glimepiride
  • Hyperglycaemia
  • Hypoglycaemic agents
  • Insulin glargine
  • Insulin glulisine
  • Korea
  • Type 2 diabetes mellitus

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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Long-term effects on glycaemic control and β-cell preservation of early intensive treatment in patients with newly diagnosed type 2 diabetes : A multicentre randomized trial. / 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.

In: Diabetes, Obesity and Metabolism, 01.01.2018.

Research output: Contribution to journalArticle

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. / Long-term effects on glycaemic control and β-cell preservation of early intensive treatment in patients with newly diagnosed type 2 diabetes : A multicentre randomized trial. In: Diabetes, Obesity and Metabolism. 2018.
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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-na{\"i}ve 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.",
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T1 - Long-term effects on glycaemic control and β-cell preservation of early intensive treatment in patients with newly diagnosed type 2 diabetes

T2 - A multicentre randomized trial

AU - Chon, Suk

AU - Rhee, Sang Youl

AU - Ahn, Kyu Jeung

AU - Baik, Sei-Hyun

AU - Park, Yongsoo

AU - Nam, Moon Suk

AU - Lee, Kwan Woo

AU - Yoo, Soon Jib

AU - Koh, Gwanpyo

AU - Lee, Dae Ho

AU - Kim, Young Seol

AU - Woo, Jeong Taek

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.

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 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.

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KW - Combination

KW - Drug therapy

KW - Glimepiride

KW - Hyperglycaemia

KW - Hypoglycaemic agents

KW - Insulin glargine

KW - Insulin glulisine

KW - Korea

KW - Type 2 diabetes mellitus

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