Effectiveness and Safety of iGlarLixi in People with Type 2 Diabetes in Adriatic Region Countries: ENSURE-ADR, a Real-World Study.

INTRODUCTION: The efficacy of iGlarLixi, a fixed-ratio combination of basal insulin glargine 100 units/mL (iGlar) and the short-acting GLP-1 RA lixisenatide (Lixi), was established in people with type 2 diabetes (T2D) who were advancing therapy from oral antidiabetic drugs (OADs) and basal insulin (BI). This retrospective study aimed to evaluate the effectiveness and safety of iGlarLixi using real-world data from people with T2D in the Adriatic region countries. METHODS: This was a non-interventional, retrospective, multicenter, cohort study with the collection of pre-existing data at iGlarLixi initiation and after 6 months of treatment in real-world clinical and ambulatory settings. The primary outcome was the change in glycated hemoglobin (HbA1c) at 6 months after iGlarLixi initiation. Key secondary outcomes included the proportion of people achieving HbA1c < 7.0%, the effect of iGlarLixi on fasting plasma glucose (FPG), body weight and body mass index (BMI). RESULTS: In this study, 262 participants (130 in Bosnia and Herzegovina, 72 in Croatia and 60 in Slovenia) initiated treatment with iGlarLixi. The participants had a mean ± SD age of 66.2 ± 7.9 years and the majority were women (58.0%). The mean baseline HbA1c was 8.9 ± 1.7% and the mean body weight was 94.3 ± 18.0 kg. After 6 months of treatment, the reduction in the mean HbA1c was statistically significant (1.11 ± 1.61%, 95% confidence internal [CI] 0.92, 1.31; p < 0.001), and the proportion of participants who achieved HbA1c < 7.0% had significantly increased from baseline (8.0-26.0%, p < 0.001). The change in mean FPG (mmol/L) levels was significant (2.7 ± 4.4 [95% CI 2.1, 3.2; p < 0.001]). The mean ± SD body weight and BMI were significantly reduced by 2.9 ± 4.3 kg (95% CI 2.3, 3.4; p < 0.001) and 1.3 ± 4.4 kg/m2 (95% CI 0.7, 1.8; p < 0.001), respectively. Two serious hypoglycemia episodes and one adverse gastrointestinal effect (nausea) were registered. CONCLUSIONS: This real-world study demonstrated the effectiveness of iGlarLixi for improving glycemic control and decreasing body weight in people with T2D who need to advance therapy from OADs or insulin.

Direct comparison two fixed-ratio combination glucagon-like peptide receptor agonist and basal insulin on glycemic and non glycemic parameters in type 2 diabetes.

BACKGROUND: Two types of fixed-ratio combinations of basal insulin and a glucagon-like peptide-1 receptor agonist (GLP-1RA) have been approved for use in type 2 diabetes. One is insulin degludec/liraglutide (iDergLira), and the other is insulin glargine/lixisenatide (iGlarLixi). Direct comparisons between these two combination is not available. METHODS: The retrospective study included 186 patients with type 2 diabetes mellitus (DM) with inadequate glycemic control on metformin and basal insulin (degludec, glargine 100, glargine 300) who were switched to fixed-ratio combination GLP-1 RA and basal insulin. Patients were divided into two groups based on the basal insulin before study: group I (n = 86) treated with degludec were switched to iDegLira and patients group II (n = 99), treated with glargine were switched to iGlarLixi. The aim of this study was to directly compare the effects between two fixed - ratio combination on glycemic parameters and non glycemic parameters. Follow up was 6 months. RESULTS: Mean HbA1c decreased similarly (- 1.2% vs.-1.1%). Higher percentage patients in iDegLira group had reached the HbA1c < 7% after 6 months (22% vs. 18.2%, p < 0.05). The mean change in fasting plasma glucose (FPG) was comparable for the two groups, while mean decrease postprandial plasma glucose (PPG) level were lower in iGlarLixi group (2 vs 1.8 mmol/l, p > 0.05). Change in body weight was significant in iDegLira group (1.8 kg vs. 0.7 kg, p < 0.001). At the end of the study patients showed decrease in total cholesterol (TC) and low-density lipoprotein (LDL) for 0.2 mmol/L in iDegLira, 0.1 mmol/l in iGlarLixi, triglycerides decreased 0.3 mmol/l in both groups, high-density lipoprotein(HDL) increased 0.1 mm/l in iGlarLixi. CONCLUSION: Our results showed that more patients with iDegLira had HbA1c less than 7% and these combination had better effect on weight loss. There was no difference observed in FPG and PPG, lipid profile and rate of hypoglycemia.

Correlation of the body mass index and calcium nephrolithiasis in adult population.

INTRODUCTION: Prevalence of the kidney stones (renal calculi) increase in several countries in parallel with the increase of overweight, diabetes (type 2 diabetes) and hypertension. GOAL: The goal of our research was to evaluate the connection between the calcium nephrolithiasis and overweight, as quantified using the Body Mass Index (BMI) of the adult population, with a particular reflection on the age groups within it. MATERIAL AND METHODS: The research was prospective and it was implemented at the Clinical Center of Banja Luka, at the Urology Clinic in the period from 1(st) April 2012 to 1(st) January 2013. The trial encompassed 120 patients with calcium nephrolithiasis of the upper part of the urinary tract and 120 patients without nephrolithiasis. A group of patients with the calcium nephrolithiasis presented a working group, while a group of patients without nephrolithiasis presented a control group. The BMI obtained on the basis of bodily weight and height of the patient, where the age and sex of specific reference values of the BMI were developed by the Center for Disease Control and Prevention (CDC) were not used in the calculation of the BMI. RESULTS: Analyzing the values of the BMI in relation to age groups, where there was a statistically significant difference in the working group, whereas in the control group there was a statistically high significant difference, testing of statistical significance of the average value of the BMI was done by observed age groups of working and control group, as well as to the total sample of work and control group using the Chi-Square test and T-test for independent samples. Having observed the age group of 20-40 years, statistically significant differences have been noted at the level of risk of 10%, which confirms that there is a connection between the categories of the BMI and the group, which the patient comes from (Chi-Square test p-0.05), that is, T-test has shown that the values are different at the level of 10%, i.e. p<0.1 (p=0.073). Having observed the age group 40-60, there was no dependency between the category of the BMI and the group, that is, the differences are not statistically significant, p>0.05 (t-test p=0.314). In addition to this, the average BMI values are not significantly different, p>0.05 (t-test p=0.871). Having observed the age group of the older than 60, there was no dependency between the category of the BMI and the group, that is, the differences are not statistically significant, p>0.05 (Chi-square test p=0.167). Having observed the total sample of the working and control group, there was no dependency of the category of the BMI and the group (or urolithiasis), p>0.05 (Chi-Square test p=1.208), whereas the results of the T-test showed that there was no statistically significant difference of the arithmetic mean values of the BMI working group and control group, p>0.05 (t-test p=0.620). CONCLUSION: Overweight in younger age groups of adult population may be connected to the occurrence of calcium nephrolithiasis, thus we suggest that urolithiasis should be considered with them, as part of overweight, by which a change of living habits and the manner of food consumption could prevent this disease.