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Higher versus standard starting dose of insulin glargine 100?U/mL in overweight or obese Chinese patients with type 2 diabetes: Results of a multicentre, open-label, randomized controlled trial (BEYOND VII).

ABSTRACT: AIM:To determine the safety of a higher starting dose of basal insulin in overweight/obese patients with type 2 diabetes (T2D). MATERIALS AND METHODS:This 16-week, randomized, multicentre, open-label trial enrolled adults with T2D (body mass index 25-40?kg/m2 ) and suboptimal glycaemic control (glycated haemoglobin [HbA1c] 7.5-11.0% [58-97 mmol/mol] and fasting plasma glucose [FPG] >9.0?mmol/L) with two to three oral anti-hyperglycaemic drugs at 51 centres in China. Patients were randomized (1:1) to a higher (0.3?U/kg) or standard (0.2?U/kg) starting dose of insulin glargine 100?U/mL, which was then titrated to achieve a self-monitored fasting blood glucose (FBG) of 4.4 to 5.6?mmol/L. The primary endpoint was the percentage of patients with ?1 episode of overall confirmed hypoglycaemia (?3.9?mmol/L or severe). RESULTS:At the end of study (n = 866), 11.0% patients treated with the 0.3?U/kg starting insulin dose experienced overall confirmed hypoglycaemia versus 8.6% of patients treated with 0.2?U/kg (estimated difference 2.1%, 95% confidence interval?-?1.68, 5.89). The proportions of patients with symptomatic (9.8% vs 7.0%; P = 0.128) and nocturnal hypoglycaemia (2.7% vs 1.2%; P = 0.102) were similar in the two groups. There were no events of severe hypoglycaemia or FBG <3.0?mmol/L during the 16-week treatment, and achievement of HbA1c <7.0% (53 mmol/mol) (37.1% vs 37.1%) or FPG <5.6?mmol/L (15.9% vs 16.3%), <6.1?mmol/L (27.6% vs 26.1%), or?

SUBMITTER: Ji L

PROVIDER: S-EPMC7187195 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Higher versus standard starting dose of insulin glargine 100 U/mL in overweight or obese Chinese patients with type 2 diabetes: Results of a multicentre, open-label, randomized controlled trial (BEYOND VII).

Ji Linong L Wan Hailong H Wen Binhong B Wang Xueying X Wang Junfen J Bian Rongwen R Pang Wuyan W Tian Jian J Wang Yan Y Bian Fang F Gao Zhengnan Z Condoleon Alex A Feng Wei W Zhang Xia X Cui Nan N

Diabetes, obesity & metabolism 20200218 5

<h4>Aim</h4>To determine the safety of a higher starting dose of basal insulin in overweight/obese patients with type 2 diabetes (T2D).<h4>Materials and methods</h4>This 16-week, randomized, multicentre, open-label trial enrolled adults with T2D (body mass index 25-40 kg/m<sup>2</sup> ) and suboptimal glycaemic control (glycated haemoglobin [HbA1c] 7.5-11.0% [58-97 mmol/mol] and fasting plasma glucose [FPG] >9.0 mmol/L) with two to three oral anti-hyperglycaemic drugs at 51 centres in China. Pat ...[more]

PMID: 31944546

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Project description:BACKGROUND:Treatment with basal insulin in Chinese populations is currently sub-optimal, with delayed initiation of insulin treatment and inadequate dose titration. Increasing the initial dose of insulin may be a practicable and effective solution to the problem of titration. A higher initial dose will be helpful for patients to achieve the blood glucose target and improve treatment satisfaction and compliance as well require fewer steps to titrate. Considering that overweight and obese patients usually require higher insulin doses because of insulin resistance, a higher initial dose of the basal insulin is feasible in overweight and obese patients with type 2 diabetes. However, safety is an important issue needing to be considered for higher initial dose treatment. The aim of this study is to assess the safety and efficacy of higher (0.3 U/kg) compared with standard (0.2 U/kg) starting doses of basal insulin in overweight and obese Chinese patients with type 2 diabetes who have failed to achieve glycaemic control using oral antidiabetic drugs (OADs). METHODS:This is a phase IV, randomized, non-inferiority, open-label trial that will be conducted at approximately 50 centers in China. Eight hundred eighty overweight and obese adult Chinese patients with type 2 diabetes will be randomized to receive higher (0.3 U/kg) or standard (0.2 U/kg) starting doses of basal insulin glargine (100 U/ml) during a 16-week period. The primary endpoint is whether a higher initial dose of basal insulin (0.3 U/kg) is non-inferior to a standard initial dose (0.2 U/kg) based on the percentage of patients with at least one episode of hypoglycaemia (≤ 3.9 mmol/l or severe) over 16 weeks. Secondary endpoints include evaluation of glycosylated haemoglobin A1c (HbA1c), fasting blood glucose, postprandial blood glucose, insulin dose and safety. DISCUSSION:This study is the first randomized-controlled study to evaluate the safety and efficacy of basal insulin treatment with a higher starting dose versus standard starting dose in overweight and obese Chinese patients with type 2 diabetes. Results of this study could generate evidence to support the feasibility of a higher starting dose of basal insulin in diabetes management of overweight and obese Chinese patients, therefore providing an easy approach to improve diabetes management. TRIAL REGISTRATION:ClinicalTrials.gov identifier, NCT02836704. Registered on July 7th 2016. FUNDING:Sanofi China.

Project description:IntroductionBEYOND 7 demonstrated that a higher starting dose (0.3 U/kg) of insulin glargine 100 U/mL (Gla-100) is as safe as the standard starting dose (0.2 U/kg) in Chinese individuals with type 2 diabetes who had uncontrolled hyperglycaemia despite receiving oral antihyperglycaemic drugs. This post hoc analysis determined the effect of baseline characteristics on hypoglycaemia risk in these individuals.MethodsParticipants from BEYOND 7 were assessed based on their age at baseline (< 60 vs. ≥ 60 years), duration of diabetes (< 10 vs. ≥ 10 years), glycated haemoglobin (HbA1c; < 9 vs. ≥ 9%) and fasting plasma glucose level (FPG; < 11 vs. ≥ 11 mmol/L). Endpoints included the proportion of participants with overall confirmed (≤ 3.9 mmol/L) and symptomatic hypoglycaemia, as well as the proportion of participants who achieved an HbA1c < 7% without hypoglycaemia, the time to first achievement of fasting blood glucose (FBG) < 7 mmol/L and the change in HbA1c from baseline between the two treatment arms in each of these subgroups.ResultsThe proportion of participants with overall confirmed (6.1-16.7%) or symptomatic hypoglycaemia (5.7-18.4%) or the proportion who achieved HbA1c < 7.0% without hypoglycaemia (23.6-47.4%) was similar between the two treatment arms in all subgroups, with the exception of participants with a baseline duration of diabetes ≥ 10 years who experienced more symptomatic hypoglycaemia if initiating Gla-100 at a dose of 0.3 versus 0.2 U/kg. Participants aged < 60 years with an HbA1c < 9% or ≥ 9% or a duration of diabetes of 2-10 years achieved an FBG < 7.0 mmol/L in a significantly shorter time with Gla-100 starting dose of 0.3 U/kg versus 0.2 U/kg (all p < 0.001). No significant differences were seen among the subgroups in terms of change from baseline in HbA1c.ConclusionsBaseline age, duration of diabetes, HbA1c level and FPG level do not affect the risk of hypoglycaemia with a higher starting dose of Gla-100 versus its standard starting dose.Trial registrationClinicalTrials.gov: NCT02836704.

Dataset Information

Higher versus standard starting dose of insulin glargine 100?U/mL in overweight or obese Chinese patients with type 2 diabetes: Results of a multicentre, open-label, randomized controlled trial (BEYOND VII).

Publications

Higher versus standard starting dose of insulin glargine 100 U/mL in overweight or obese Chinese patients with type 2 diabetes: Results of a multicentre, open-label, randomized controlled trial (BEYOND VII).

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