Safety of Insulin Degludec/Insulin Aspart in Patients with Diabetes Mellitus over a Period of 1 Year during Routine Clinical Care in India: SMART (Study of Management of Diabetes with Ryzodeg™ Treatment).

This post-authorization study was conducted to evaluate the safety of insulin degludec/insulin aspart (IDegAsp) in adult patients with diabetes mellitus (DM) during routine clinical care under a real-world setting in India. Eligible patients received IDegAsp for a minimum of 12 months during routine clinical management. Data were collected at 0, 3, 6, and 12 months. In total, 1029 adult patients with DM were included; 65.2% (n = 671) were men; mean age was 55.0 ± 12.2 years, and the mean duration of diabetes mellitus was 10.8 ± 7.4 years. Thirty adverse events were reported in 23 patients (2.2%) during the follow-up: two adverse events in two patients were serious with fatal outcomes, which were unrelated to IDegAsp use. At baseline, there were 176 confirmed hypoglycemic events in 67 (6.7%) patients while they were on their previous treatment options. At 12 months of treatment with IDegAsp, 11 confirmed hypoglycemic events were reported in 11 (1.1%) patients since the previous visit; there were no reported episodes of severe hypoglycemia. Mean glycosylated hemoglobin value reduced from 9.5% ± 1.8% at baseline to 7.7% ± 1.1% at 12 months. This study showed the safety of IDegAsp in patients with diabetes mellitus over a period of 1 year during routine clinical care.

Does vitamin D play a significant role in type 2 diabetes?

BACKGROUND: Vitamin D deficiency reportedly is associated with type 2 diabetes (T2DM). We aim to examine whether 25-hydroxyvitamin D (25OHD) has clinically significant influence on hemoglobin glycation (HbA1c) and insulin resistance (HOMA-IR) in T2DM subjects. METHODS: Present study was carried out in 912 subjects (429 T2DM cases and 483 non-diabetic controls) from Western India. The enrolled study subjects were investigated for biochemical parameters like FBS, PPBS, HbA1c, FI, HOMA-IR and 25OHD levels in blood. RESULTS: Vitamin D deficiency was seen in 91.4% and 93.0% of T2DM cases and control subjects respectively. There was no association of serum 25OHD deficiency on HbA1c or HOMA-IR in T2DM cases (p = 0.057 & p = 0.257 respectively) and in control subjects (p = 0.675 & p = 0.647 respectively). CONCLUSION: Our findings suggests that though vitamin D deficiency is prevalent in T2DM and non-diabetic subjects, its role in hemoglobin glycation and insulin resistance could not be established.

The association of dyslipidemia and obesity with glycated hemoglobin.

BACKGROUND: Dyslipidemia and obesity are the most common complex metabolic disorders taking the highest toll of health resources globally by its increasing incidences. This consequently leads to type 2 diabetes mellitus (T2DM) and cardiovascular disorders (CVDs) with variable reports about the role of metabolic factors on glycemic control. The current study is designed to determine the association of dyslipidemia and obesity with glycated hemoglobin (HbA1c) in T2DM and non-diabetic subjects. METHODS: The present study was carried out in 931 subjects from urban Western India including 430 diabetic and 501 non-diabetic subjects with detailed anthropometric parameters. All subjects were investigated for HbA1c and lipid parameters like TC, TG, HDL-C, LDL-C and non-HDL-C. RESULTS: Dyslipidemia, central- and peripheral- obesity were observed (50.27 %; 75 % and 59.83 %) in all the study subjects respectively. Additionally, hyper-non-HDL-C was detected in 23.49 % and 22.56 % in T2DM and non-diabetic subjects. Significant linear associations of hyper-TC, hyper-LDL-C and hyper-non-HDL-C were observed with HbA1c in T2DM and non-diabetic control subjects respectively. Centrally- and peripherally- obese dyslipidemic subjects also showed a significant association with HbA1c in T2DM and control subjects respectively. CONCLUSION: This study demonstrates the high prevalence of dyslipidemia and obesity in all subjects irrespective of their disease status in a Western Indian population. The dyslipidemic obese subjects had significant linear association with HbA1c in T2DM subjects.

Prevalence of overweight and obesity in Indian adolescent school going children: its relationship with socioeconomic status and associated lifestyle factors.

AIMS AND OBJECTIVES: Obesity and overweight have become a worldwide epidemic, and there is an urgent need to examine childhood obesity and overweight across countries using a standardized international standard. In the present study we have investigated the prevalence of obesity and overweight and their association with socioeconomic status (SES) and the risk factors like diet, physical activity like exercise, sports, sleeping habit in afternoon, eating habits like junk food, chocolate, eating outside at weekend, family history of diabetes and obesity. MATERIAL AND METHODS: The study was carried out in 5664 school children of 12-18 years of age and having different SES. The obesity and overweight were considered using an updated body mass index reference. SES and life style factors were determined using pre-tested questionnaire. RESULTS: Age-adjusted prevalence of overweight was found to be 14.3% among boys and 9.2% among girls where as the prevalence of obesity was 2.9% in boys and 1.5% in girls. The prevalence of overweight among children was higher in middle SES as compared to high SES group in both boys and girls whereas the prevalence of obesity was higher in high SES group as compared to middle SES group. The prevalence of obesity as well as overweight in low SES group was the lowest as compared to other group. Eating habit like junk food, chocolate, eating outside at weekend and physical activity like exercise, sports, sleeping habit in afternoon having remarkable effect on prevalence on overweight and obesity among middle to high SES group. Family history of diabetes and obesity were also found to be positively associated. CONCLUSION: Our data suggest that the prevalence of overweight and obesity varies remarkably with different socioeconomic development levels.