ArticleAdvances in therapy2018
Safety and Efficacy of High Versus Standard Starting Doses of Insulin Glargine in Overweight and Obese Chinese Individuals with Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Medications (Beyond VII): Study Protocol for a Randomized Controlled Trial.
Article in Advances in therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02836704. Cited by 4 papers.
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Comparison of Efficacy and Safety of Standard vs Higher Starting Dose of Insulin Glargine in Overweight and Obese Chinese Patients With Type 2 Diabetes
Open the trial in the graphWho cites it
4 citing papers in PubMed, 5 citations in OpenAlex.
- 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).Diabetes, obesity & metabolism · 2020Trial
- Effect of Baseline Characteristics on Hypoglycaemia Risk with Insulin Glargine 100 U/mL: Post Hoc Analysis of the BEYOND 7 Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021Article
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Authors and funding
8 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTreatment 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).
methodsThis 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 registrationClinicalTrials.gov identifier, NCT02836704. Registered on July 7th 2016.
fundingSanofi China.
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