To view enhanced digital features for this article go to https://doi.org/10.6084/m9.figshare.6269984.
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).
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.
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.
ClinicalTrials.gov identifier, NCT02836704. Registered on July 7th 2016.
International Diabetes Federation. Diabetes Atlas, 7th ed. Brussels: International Diabetes Federation, 2015. http://www.diabetesatlas.org. Accessed 21 Sep 2017.
American Diabetes Association. Standards of medical care in diabetes-2017. Diabetes Care. 2017;40:S1–135. CrossRef
Zhang B, Zhao J, Yang W, et al. Glycemic control and safety in Chinese patients with type 2 diabetes mellitus who switched from premixed insulin to insulin glargine plus oral antidiabetics: a large, prospective, observational study. Diabetes Metab Res Rev. 2017;33:e2863. CrossRef
Chow SC, Shao J, Wang H. Sample size calculations in clinical research, 2nd ed. Chapman Hall/CRC Biostatistics Series; 2008.
Owens DR, Traylor L, Dain MP, et al. Efficacy and safety of basal insulin glargine 12 and 24 weeks after initiation in persons with type 2 diabetes: a pooled analysis of data from treatment arms of 15 treat-to-target randomised controlled trials. Diabetes Res Clin Pract. 2014;106:264–74. CrossRefPubMed
Ji L, Newman J, Lu J, et al. Understanding the standard of care in the treatment of type 2 diabetes in China: results from a national survey. Chin Med J (Engl). 2014;127:3524–9.
Sorli CandHeile MK. Identifying and meeting the challenges of insulin therapy in type 2 diabetes. J Multidiscip Healthc. 2014;7:267–82. CrossRef
Yki-Jarvinen H, Dressler A, Ziemen M, et al. Less nocturnal hypoglycemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in type 2 diabetes. HOE 901/3002 Study Group. Diabetes Care. 2000;23:1130–6. CrossRefPubMed
- 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
- Springer Healthcare
Neu im Fachgebiet Innere Medizin
Meistgelesene Bücher aus der Inneren Medizin
e.Med Kampagnen-Visual, Mail Icon II