BE-SMART (Basal Early Strategies to Maximize HbA1c Reduction with Oral Therapy): Expert Opinion.

The past three decades have seen a quadruple rise in the number of people affected by diabetes mellitus worldwide, with the disease being the ninth major cause of mortality. Type 2 diabetes mellitus (T2DM) often remains undiagnosed for several years due to its asymptomatic nature during the initial stages. In India, 70% of diagnosed diabetes cases remain uncontrolled. Current guidelines endorse the initiation of insulin early in the course of the disease, specifically in patients with HbA1c > 10%, as the use of oral agents alone is unlikely to achieve glycemic targets. Early insulin initiation and optimization of glycemic control using insulin titration algorithms and patient empowerment can facilitate the effective management of uncontrolled diabetes. Early glucose control has sustained benefits in people with diabetes. However, insulin initiation, dose adjustment, and the need to repeatedly assess blood glucose levels are often perplexing for both physicians and patients, and there are misconceptions and concerns regarding its use. Hence, an early transition to insulin and ideal intensification of treatment may aid in delaying the onset of diabetes complications. This opinion statement was formulated by an expert panel on the basis of existing guidelines, clinical experience, and economic and cultural contexts. The statement stresses the timely and appropriate use of basal insulin in T2DM. It focuses on the seven vital Ts-treatment initiation, timing of administration, transportation and storage, technique of administration, targets for titration, tablets, and tools for monitoring.Funding: Sanofi.

Consensus statement on insulin therapy in chronic kidney disease.

INTRODUCTION: Diabetes mellitus (DM) is one of the leading causes of chronic kidney disease (CKD) which eventually leads to insulin resistance and decreased insulin degradation. In patients with diabetic kidney disease (DKD), the overall insulin requirement declines which necessitates the reassessment for individualization, adjustment and titration of insulin doses depending on the severity of kidney disease. OBJECTIVE: To provide simple and easily implementable guidelines to primary care physicians on appropriate insulin dosing and titration of various insulin regimens in patients with DKD. METHODS: Each insulin regimen (basal, prandial, premix and basal-bolus) was presented and evaluated for dosing and titration based on data from approved medical literatures on chronic kidney disease. These evaluations were then factored into the national context based on the expert committee representatives' and key opinion leaders' clinical experience and common therapeutic practices followed in India. RESULTS: Recommendations based on dosing and titration of insulins has been developed. Moreover, the consensus group also recommended the strategy for dose estimation of insulin, optimal glycaemic targets and self-monitoring in patients with DKD. CONCLUSION: The consensus based recommendations will be a useful reference tool for health care practitioners to initiate, optimise and intensify insulin therapy in patients with DKD.

Overview of Clinical Trial Program and Applicability of Insulin Degludec/Insulin Aspart in Diabetes Management.

Insulin degludec/insulin aspart (IDegAsp) is the first soluble coformulation combining a long-acting insulin degludec (IDeg) and rapid-acting insulin aspart (IAsp). In patients with uncontrolled type 2 diabetes (T2DM) previously treated with insulins, IDegAsp twice daily effectively improves glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) levels with fewer hypoglycaemic episodes versus premix insulins. Further, insulin initiation with IDegAsp once daily provides superior long-term glycaemic control compared to insulin glargine with similar FPG and insulin doses, and numerically lower rates of overall and nocturnal hypoglycaemia. In patients with type 1 diabetes mellitus (T1DM), IDegAsp once daily and IAsp at remaining meals provides more convenient three injection regimen per day over conventional 4-5 injections based basal-bolus therapy. IDegAsp is an appropriate and reasonable option for intensifying insulin therapy in patients with T2DM and a relatively less complex treatment option for the management of T1DM.

Prevalence of dyslipidemia in adult Indian diabetic patients: A cross sectional study (SOLID).

CONTEXT: India leads the world with largest number of diabetic patients and is often referred to as the diabetes capital of the world. Diabetic dyslipidemia in India is one of the main cause for Coronary Artery Disease (CAD) mortality. Although diabetes continues to be a major lifestyle condition in India, there is a lack of studies in India on whether dyslipidemia in Indian diabetics is being adequately controlled. Our study provides critical insights into the insights into proportion of diabetes patients achieving lipid goal in India. AIMS: The primary objective of our study was to assess the control of dyslipidemia in the Indian diabetic population treated with lipid lowering drugs (LLDs), as per American Diabetes Association (ADA) 2010 guidelines. SETTINGS AND DESIGN: The study was carried out in a real world Indian clinical setting involving 178 sites. This is a multicenter, noninterventional, and cross-sectional observational study. MATERIALS AND METHODS: A total of 5400 adult subjects with established type-2 diabetes mellitus (T2DM) and dyslipidemia were recruited for the study. Patients in the study were on LLD at a stable dose for at least last 3 months before the designated study visit. Routine lipid profile tests were conducted for all patients. STATISTICAL ANALYSIS USED: Descriptive statistics was used to analyze qualitative and discrete variables. Chi-square test and t-test were conducted to assess the existence of statistically significant association between the variables. RESULTS: A total of 5400 patients with T2DM from 178 centers across India were recruited. Out of the total population, 56.75% (N = 3065) of them were males. Primary end-point of low-density lipoprotein cholesterol (LDL-C) level below ADA 2010 target was achieved in a total of 48.74% (N = 2632) patients. Gender was significantly associated with lipid levels and age was significantly (P < 0.05) correlated with all lipid levels. Control rates of other lipid parameters like high-density lipoprotein cholesterol, triglyceride, and total cholesterol in the study were 60.48% (N = 3236), 57.54% (N = 3107), and 92.24% (N = 4981) respectively. Among those with overt cardiovascular disease (CVD), target LDL-C level of < 70 mg/dL was achieved in 22.87% (70 out of 306) patients. The LDL-C levels of 49.03% (N = 1768) patients who were on statin therapy were within target levels, while 53.46% (N = 634) patients who were on statin and their combinations with other LLDs had their LDL-C levels within the stipulated range. CONCLUSIONS: This study has reveled that dyslipidemia control in Indian T2DM patients is very poor with almost half of them not reaching their LDL -C goal. Dyslipidemia being one of the main risk factors for CVD in T2DM patients there is a need to treat dyslipidemia aggressively to reduce risk of future CV events.

Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Tamil Nadu cohort of the A1chieve study.

BACKGROUND: The A1chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66,726) in routine clinical care across four continents. MATERIALS AND METHODS: Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from Tamil Nadu, India. RESULTS: A total of 2221 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Patients had started on or were switched to biphasic insulin aspart (n = 1707), insulin detemir (n = 270), insulin aspart (n = 85), basal insulin plus insulin aspart (n = 79) and other insulin combinations (n = 80). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 9.2%) and insulin user (mean HbA1c: 9.2%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA1c (insulin naïve: -1.7%, insulin users: -1.7%). SADRs including major hypoglycaemic events did not occur in any of the study patients. CONCLUSION: Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia.