Ghosal Samit, Sinha Binayak, Majumder Anirban, Das Ashok Kumar, Singh Awadhesh Kumar, Ghoshdastidar Biswajit, Maji Debasish, Goyal Ghanshyam, Mukherjee Jagat Jyoti, Gangopadhyay Kalyan Kumar, John Mathew, Chatterjee Sanjay, Jaggi Shalini, Ray Subir, Majumdar Sujoy, Sharma Surendra Kumar
Nightingale Hospital, Kolkata, West Bengal.
Department of Endocrinology, AMRI Hospital, Kolkata, West Bengal.
J Assoc Physicians India. 2017 Jul;65(7):51-62.
Type 2 diabetes mellitus (T2DM) has attained epidemic proportions and continues to increase despite the availability of a number of oral antidiabetic medications and major advances made in insulin delivery since its discovery nearly a hundred years ago. One, amongst many other reasons responsible for the inability to achieve adequate glycaemic control in a substantial proportion of T2DM patients is the delayed initiation and inappropriate intensification of insulin treatment. Appropriate initiation and intensification of insulin is critical for the successful achievement of tight glycaemic control.
To provide simple and easily implementable guidelines to primary care physicians on basal insulin initiation and intensification, along with use of basal insulin in special situations (hepatic failure, renal failure and gestational diabetes mellitus).
Each consensus statement on basal insulin initiation, intensification and use of basal insulin in special situations was evaluated for dosing and titration based on established guidelines, data from approved pack inserts, prescribing information or summary of product characteristics for each insulin type, and published scientific literature. These evaluations were then factored into the national context based not only on the clinical experience of the expert committee representatives' but also based on the common therapeutic practices followed in India to successfully achieve optimal glucose control.
Recommendations on initiation and intensification of basal insulin, and its use in special situations, have been developed. The key recommendations are to initiate basal insulin when 2 or 3 oral antidiabetic medications fail to achieve target glycaemic control, or in symptomatic patients with glycated haemoglobin value greater than 9%. Depending upon patient characteristics, any of the four available basal insulins [Neutral protamine Hagedorn (NPH), Glargine (IGlar), Detemir (IDet), Degludec (IDeg)] can be used. However, IDeg has a longer duration of action, comparatively lesser hypoglycaemia (both overall and nocturnal) and more flexibility in administration timing compared to IGlar) and IDet. Inability to maintain glycaemic control should lead to prompt intensification of basal insulin treatment by adding mealtime insulin, consisting of one to three injections of either rapid-acting insulin analog or regular insulin; depending upon patient characteristics, intensification can also be achieved by transition from basal insulin to twice daily premixed insulin analogs/premixed human insulin/insulin co-formulations. IDeg/IDet can be used in all grades of renal and hepatic impairment; and IDet has been approved for use in gestational diabetes mellitus.
We hope that these consensus based recommendations shall be a useful reference tool for health care practitioners and help them in initiating and intensifying insulin therapy in T2DM patients in order to achieve optimal glycaemic control.
2型糖尿病(T2DM)已呈流行态势,尽管自近百年前发现以来已有多种口服抗糖尿病药物问世,且胰岛素给药技术取得了重大进展,但该疾病仍在持续增加。在众多导致相当一部分T2DM患者无法实现充分血糖控制的原因中,胰岛素治疗启动延迟和强化不当是其中之一。适当启动和强化胰岛素治疗对于成功实现严格血糖控制至关重要。
为基层医疗医生提供关于基础胰岛素启动和强化的简单且易于实施的指南,以及基础胰岛素在特殊情况(肝功能衰竭、肾功能衰竭和妊娠期糖尿病)中的使用方法。
根据既定指南、每种胰岛素类型的批准包装说明书数据、处方信息或产品特性摘要以及已发表的科学文献,对关于基础胰岛素启动、强化及在特殊情况中使用的每项共识声明进行剂量和滴定评估。然后,不仅基于专家委员会代表的临床经验,还基于印度为成功实现最佳血糖控制而遵循的常见治疗实践,将这些评估纳入本国实际情况。
制定了关于基础胰岛素启动、强化及其在特殊情况中使用的建议。关键建议是,当2种或3种口服抗糖尿病药物未能实现目标血糖控制时,或糖化血红蛋白值大于9%的有症状患者中,启动基础胰岛素治疗。根据患者特征,可使用四种可用基础胰岛素中的任何一种[中性鱼精蛋白锌胰岛素(NPH)、甘精胰岛素(IGlar)、地特胰岛素(IDet)、德谷胰岛素(IDeg)]。然而,与IGlar和IDet相比,IDeg作用持续时间更长,低血糖发生率相对较低(总体和夜间均如此),给药时间更灵活。若无法维持血糖控制,应通过添加餐时胰岛素迅速强化基础胰岛素治疗,餐时胰岛素由一至三次注射速效胰岛素类似物或常规胰岛素组成;根据患者特征,也可通过从基础胰岛素转换为每日两次预混胰岛素类似物/预混人胰岛素/胰岛素复方制剂来实现强化。IDeg/IDet可用于所有程度的肝肾功能损害;IDet已获批用于妊娠期糖尿病。
我们希望这些基于共识的建议将成为医疗保健从业者的有用参考工具,并帮助他们在T2DM患者中启动和强化胰岛素治疗,以实现最佳血糖控制。