Efficacy and Safety of Omarigliptin, a Novel Once-Weekly Dipeptidyl Peptidase-4 Inhibitor, in Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis.

BACKGRUOUND: No recent meta-analysis has holistically analyzed and summarized the efficacy and safety of omarigliptin in type 2 diabetes mellitus (T2DM). We conducted a meta-analysis to address this knowledge gap. METHODS: Electronic databases were searched to identify randomized controlled trials (RCTs) that included patients with T2DM who received omarigliptin in the intervention arm. The control arm consisted of either a placebo (passive control group [PCG]) or an active comparator (active control group [ACG]). The primary outcome assessed was changes in hemoglobin A1c (HbA1c), while secondary outcomes included variations in glucose levels, achievement of glycemic targets, adverse events (AEs), and hypoglycemic events. RESULTS: From 332 initially screened articles, data from 16 RCTs involving 8,804 subjects were analyzed. Omarigliptin demonstrated superiority over placebo in reducing HbA1c levels (mean difference, -0.58%; 95% confidence interval, -0.75 to -0.40; P<0.00001; I2=91%). Additionally, omarigliptin outperformed placebo in lowering fasting plasma glucose, 2-hour postprandial glucose, and in the percentage of participants achieving HbA1c levels below 7.0% and 6.5%. The glycemic efficacy of omarigliptin was similar to that of the ACG across all measures. Although the omarigliptin group experienced a higher incidence of hypoglycemic events compared to the PCG, the overall AEs, serious AEs, hypoglycemia, and severe hypoglycemia were comparable between the omarigliptin and control groups (PCG and ACG). CONCLUSION: Omarigliptin has a favorable glycemic efficacy and safety profile for managing T2DM.

Status of lipid control in Bangladeshi subjects with type 2 diabetes mellitus on lipid-lowering drugs: a multicenter, facility-based, cross-sectional study.

BACKGROUND: Achievement of lipid targets is crucial in patients with type 2 diabetes mellitus (T2DM) to mitigate the risk of cardiovascular diseases (CVD). Data on lipid-control status among patients with T2DM in Bangladesh are scarce. This study was conducted to determine the lipid-control status among patients with T2DM who were on lipid-lowering drugs in the country. METHODS: This cross-sectional study was conducted in the diabetes outpatient departments of several tertiary hospitals in Bangladesh from January 2022 to December 2022. Adults of both sexes diagnosed with T2DM for at least one year and were on the lipid-lowering drug(s) for a minimum of 3 months were included in the study by consecutive sampling. Patients' data were collected by face-to-face interviews, and blood samples were collected for fasting lipid profile. The lipid target was set at < 200 mg/dL for total cholesterol (TC), < 150 mg/dL for triglyceride (TG), < 100 mg/dL for low-density lipoprotein cholesterol (LDL-C), > 40 mg/dL for high-density lipoprotein cholesterol (HDL-C), and < 160 mg/dL for non-HDL cholesterol (non-HDL-C). RESULT: Three thousand sixty patients (age 44.7 ± 13.3 years, female 57%) with T2DM were evaluated. Overall, almost 81% of the study subjects achieved the LDL-C target. Besides, TC, TG, HDL-C, and non-HDL-C targets were achieved by 40.8, 21.6, 66.3, and 44.1% of patients, respectively. However, all the lipid parameters were under control in only 8.8% of patients. Almost 77.6% of the patients with ischemic heart disease, 81.5% of patients with stroke, and 65% of patients with CKD had LDL levels < 70 mg/dL. Only 10.03% achieved the HbA1c target of < 7%. 7.4% of patients achieved both HbA1c < 7% and LDL < 100 mg/dL and 5% achieved both HbA1c < 7% and LDL < 70 mg/dL. Advanced age (aOR 0.97, 95% CI 0.96, 0.98, p < 0.001), longstanding T2DM (aOR 0.53, 95% CI 0.39, 0.72, p < 0.001), and non-statin therapy (aOR 0.25, 95% CI 0.16, 0.37, p < 0.001) were negatively associated with lipid control (LDL < 100 mg/dL) while using oral hypoglycemic drugs or insulin (aOR 2.01, 95% CI 1.45, 2.77, p < 0.001) and having cardiovascular comorbidity (aOR 3.92, 95% CI 3.00, 5.12, p < 0.001) were positively associated with lipid control. CONCLUSION: Though most patients with T2DM achieved their target LDL level, the prevalence of both glycemic and overall lipid control was low in our study despite lipid-lowering therapy.

Comparison of fasting and random lipid profiles among subjects with type 2 diabetes mellitus: an outpatient-based cross-sectional study in Bangladesh.

BACKGROUND: Despite the wide acceptability of fasting lipid profiles in practice, emerging evidence suggests that random lipid profiles might be a convenient alternative for lipid measurement. The objective of the present study was to compare the fasting and random lipid profile among subjects with type 2 diabetes mellitus (T2DM). METHODS: The present cross-sectional study included 1543 subjects with T2DM visiting several endocrinology outpatient clinics throughout Bangladesh from January to December 2021. The fasting lipid profile was measured in the morning following 8-10 h of overnight fasting, and the random lipid profile was measured at any time of the day, irrespective of the last meal. The values of fasting and random lipids were compared using the Wilcoxon signed-rank test and Spearman rank correlation coefficients. RESULTS: In this study, a good level of correlation was observed between fasting and random lipid levels [r = 0.793, p < 0.001 for triglyceride (TG); r = 0.873, p < 0.001 for low-density lipoprotein cholesterol (LDL-C); r = 0.609, p < 0.001 for high-density lipoprotein cholesterol (HDL-C); and r = 0.780, p < 0.001 for total cholesterol (TC)]. In addition, TG and TC levels increased by 14% and 0.51%, respectively, in the random state compared to the fasting state (p- <0.05), while LDL-C levels decreased by 0.71% (p-value 0.42). No change was noticed in the HDL-C level. The difference between fasting and random lipid profiles was similar irrespective of patients' age, sex, BMI, glucose-lowering drug(s), and lipid-lowering therapy. CONCLUSIONS: Random lipid profile correlates significantly with fasting lipid profile with little difference. Hence, it might be a reliable alternative for fasting lipid profile in patients with T2DM.

Sexual dysfunction in women with type 2 diabetes mellitus: A single-centre cross-sectional study from Bangladesh.

Objective: Sexual dysfunction among women with diabetes is a common but neglected health issue worldwide. The objective of the present study was to investigate the prevalence of sexual dysfunction and its associated factors among women with type 2 diabetes mellitus (T2DM). Subjects and methods: This cross-sectional comparative study comprises 150 women with diabetes and 100 healthy women without diabetes who visited the endocrinology outpatient department of Mymensingh Medical College Hospital (MMCH). The data were collected from July to December 2019. Sexual dysfunction was assessed by the 19-item Female Sexual Function Index (FSFI). Informed consent was obtained before participation. Collected data were analysed by SPSS 26. Results: More women with diabetes than control subjects reported sexual dysfunction (79% vs. 72%; p = 0.864). The global FSFI score was lower among the diabetes patients than among the healthy controls (20.8 ± 7.2 vs. 23.7 ± 4.8; p < 0.001). Patients with T2DM scored significantly lower in the domains of desire (p = 0.04), lubrication (p = 0.01), orgasm (p = 0.01), and satisfaction (p < 0.001), but not the domain of arousal (p = 0.09). A prolonged duration of diabetes was the primary contributor to orgasm problems (adjusted odds ratio, aOR 1.3, 95% CI 1.1-1.7) and painful intercourse (aOR 1.2, 95% CI 1.1- 1.5). Conclusion: Sexual problems are frequent in women with diabetes. Inclusion of sexual health in comprehensive diabetes management is crucial to address this problem as well as to improve the quality of life of female diabetes patients.

Risk stratification using the 2021 IDF-DAR risk calculator and fasting experience of Bangladeshi subjects with type 2 diabetes in Ramadan: The DAR-BAN study.

Aims: To risk-stratify patients with type 2 diabetes mellitus (T2DM) according to the IDF-DAR 2021 guidelines and observe their responsiveness to risk-category-based recommendations and fasting experience. Methods: This prospective study, conducted in the peri-Ramadan period of 2022, evaluated adults with T2DM and categorized them using the IDF-DAR 2021 risk stratification tool. Recommendations for fasting according to the risk categories were made, their intention to fast was recorded, and follow-up data were collected within one month of the end of Ramadan. Results: Among 1328 participants (age 51.1 ± 11.9 years, female 61.1 %), only 29.6 % had pre-Ramadan HbA1c < 7.5 %. According to the IDF-DAR risk category, the frequencies of participants in the low-risk (should be able to fast), moderate-risk (not to fast), and high-risk (should not fast) groups were 44.2 %, 45.7 %, and 10.1 %, respectively. Most (95.5 %) intended to fast, and 71 % fasted the full 30 days of Ramadan. The overall frequencies of hypoglycemia (3.5 %) and hyperglycemia (2.0 %) were low. Hypoglycemia and hyperglycemia risks were 3.74-fold and 3.86-fold higher in the high-risk group than in the low-risk group. Conclusion: The new IDF-DAR risk scoring system seems conservative in the risk categorization of T2DM patients in terms of fasting complications.

Comparison of simplicity, convenience, safety, and cost-effectiveness between use of insulin pen devices and disposable plastic syringes by patients with type 2 diabetes mellitus: a cross-sectional study from Bangladesh.

INTRODUCTION: Insulin pen devices and disposable plastic insulin syringes are two common tools for insulin administration. This study aims to compare the simplicity, convenience, safety, and cost-effectiveness of insulin pens versus syringe devices in patients with type 2 diabetes mellitus (T2DM). METHODS: A cross-sectional study was conducted at 14 diabetes clinics throughout Bangladesh from November 2021 to April 2022 among adults with T2DM injecting insulin by pen devices or disposable insulin syringes at least once a day for at least one year by purposive sampling. The simplicity, convenience, and safety of insulin devices were assessed using a structured questionnaire, and the study subjects were scored based on their answers; higher scores indicated a poorer response. Total scores for simplicity, convenience, and safety were obtained by adding the scores for relevant components. Their average monthly medical expense and cost of insulin therapy were recorded. The median values of the total scores and monthly expenses were compared between pen devices and disposable syringe users. RESULTS: 737 subjects were evaluated; 406 were pen users, and 331 were vial syringe users. The pen users had lower median scores for simplicity [6.0 (5.0-8.0) vs. 7.0 (5.0-9.0), p = 0.002], convenience [4.0 (3.0-6.0) vs. 5.0 (4.0-6.0), p < 0.001], and safety [7.0 (6.0-8.0) vs. 7.0 (6.0-9.0), p = 0.008] than vial syringe users. Pen devices were more expensive than vial syringes in terms of average medical expense per month [BDT 5000 (3500-7000) vs. 3000 (2000-5000), p < 0.001], the total cost of insulin therapy per month [BDT 2000 (1500-3000) vs. 1200 (800-1700), p < 0.001] and cost per unit of insulin used [BDT 2.08 (1.39-2.78) vs. 0.96 (0.64-1.39), p < 0.001]. Non-significant differences in favor of pens were observed in HbA1c levels [8.7 (7.8-10) vs. 8.9 (7.9-10)%, p = 0.607] and proportions of subjects having HbA1c < 7% (6.9 vs. 6.3%, p = 0.991). CONCLUSION: Insulin pens are simpler, more convenient, and safe but more expensive than vial syringes. Glycemic control is comparable between pen and syringe users. Long-term follow-up studies are needed to determine the clinical and economic impacts of such benefits of insulin pens.

Sexual dysfunction in women with type 2 diabetes mellitus: A single-centre cross-sectional study from Bangladesh

ABSTRACT Objective: Sexual dysfunction among women with diabetes is a common but neglected health issue worldwide. The objective of the present study was to investigate the prevalence of sexual dysfunction and its associated factors among women with type 2 diabetes mellitus (T2DM). Subjects and methods: This cross-sectional comparative study comprises 150 women with diabetes and 100 healthy women without diabetes who visited the endocrinology outpatient department of Mymensingh Medical College Hospital (MMCH). The data were collected from July to December 2019. Sexual dysfunction was assessed by the 19-item Female Sexual Function Index (FSFI). Informed consent was obtained before participation. Collected data were analysed by SPSS 26. Results: More women with diabetes than control subjects reported sexual dysfunction (79% vs. 72%; p = 0.864). The global FSFI score was lower among the diabetes patients than among the healthy controls (20.8 ± 7.2 vs. 23.7 ± 4.8; p < 0.001). Patients with T2DM scored significantly lower in the domains of desire (p = 0.04), lubrication (p = 0.01), orgasm (p = 0.01), and satisfaction (p < 0.001), but not the domain of arousal (p = 0.09). A prolonged duration of diabetes was the primary contributor to orgasm problems (adjusted odds ratio, aOR 1.3, 95% CI 1.1-1.7) and painful intercourse (aOR 1.2, 95% CI 1.1-1.5). Conclusion: Sexual problems are frequent in women with diabetes. Inclusion of sexual health in comprehensive diabetes management is crucial to address this problem as well as to improve the quality of life of female diabetes patients.

Prevalence and predictors of diabetes distress among adults with type 2 diabetes mellitus: a facility-based cross-sectional study of Bangladesh.

INTRODUCTION: Diabetes distress (DD) is common and has considerable impacts on diabetes management. Unfortunately, DD is less discussed and frequently underestimated. This study evaluated the prevalence and predictors of DD in adults with type 2 diabetes mellitus (T2DM). METHODS: A cross-sectional study was conducted at several specialized endocrinology outpatient clinics in Bangladesh from July 2019 to June 2020; 259 adults with T2DM participated. Participants' DD and depression were measured using the 17-item Diabetes Distress Scale (DDS-17) and 9-item Patient Health Questionnaire (PHQ-9), respectively. DDS-17 scores ≥2 and PHQ-9 scores ≥10 were the cutoffs for DD and significant depression, respectively. RESULTS: The mean (±SD) age of the participants was 50.36 (±12.7) years, with the majority (54.8%) being male; their median (IQR) duration of diabetes was 6 (3-11) years. Among the study participants, 52.5% had DD (29.7% moderate and 22.8% high DD). The prevalence of emotional burden, physician-related distress, regimen-related distress, and interpersonal distress was 68.7, 28.6, 66, and 37.7%, respectively. Depression was present in 40.5%; 28.6% of the participants had DD and depression. The total DDS-17 score was positively correlated with the PHQ-9 score (r = 0.325, p < 0.001). Rural residence (OR 1.94), presence of any diabetic complication (OR 3.125), insulin use (OR 2.687), and presence of major depression (OR 4.753) were positive predictors of DD. In contrast, age ≥ 40 years at diabetes diagnosis (OR 0.047) and diabetes duration of > 10 years (OR 0.240) were negative predictors of DD (p < 0.05 in all instances). CONCLUSIONS: The prevalence of DD in our setting is notably high; DD and depression frequently overlap. Screening for diabetes distress may be considered, especially in high-risk patients.

Liver Stiffness Measurement by Using Transient Elastography in Bangladeshi Patients with Type 2 Diabetes Mellitus and Ultrasonography-Diagnosed Nonalcoholic Fatty Liver Disease.

PURPOSE: Type 2 diabetes mellitus (T2DM) is associated with an increased risk of nonalcoholic fatty liver disease (NAFLD), and the presence of T2DM tremendously drives NAFLD progression. The use of transient elastography (TE) for assessment of NAFLD has been increasing due to its high sensitivity and specificity. This study aimed to measure liver stiffness in patients with T2DM and ultrasonography (USG)-diagnosed NAFLD and assess the correlations between liver stiffness and other clinical and biochemical parameters. PATIENTS AND METHODS: This cross-sectional study assessed 205 adult patients with T2DM and USG-diagnosed NAFLD who were being treated at a specialized endocrine private practice in Bangladesh. All subjects underwent TE for hepatic fibrosis assessment, which was performed using a FibroScan® 402 device. A fibrosis score ≥9.7 kilopascals (kPa) was used to define advanced fibrosis (≥F3). RESULTS: Out of 205 (65.9% female, mean age 45 ± 27 years, 67.3% obese) patients, the frequencies of Grade 1, Grade 2, and Grade 3 fatty liver on USG were 46.3%, 51.2%, and 2.4%, respectively. According to the TE results, 41 (20%) had advanced fibrosis (≥F3). Subjects with advanced fibrosis had a higher body mass index (BMI), higher levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and higher frequencies of individuals with elevated ALT and AST and advanced fatty liver grades on USG. The fibrosis score (kPa) was strongly and positively correlated with age, BMI, waist circumference, obesity, serum ALT and AST levels, and the fatty liver grade in USG; the AST:ALT ratio did not correlate with kPa. CONCLUSION: The data showed that 20% of the subjects with T2DM having NAFLD on USG exhibited advanced fibrosis, demonstrating the need for early diagnosis and treatment of NAFLD in T2DM. The use of TE with other serum markers can be helpful for the diagnosis of advanced fibrosis.

Serum vitamin B12 status of patients with type 2 diabetes mellitus on metformin: A single-center cross-sectional study from Bangladesh.

BACKGROUND: Metformin use is a known cause of B12 deficiency in patients with type 2 DM (T2DM). Diabetic peripheral neuropathy (DPN) often has clinically indistinguishable clinical features of B12 deficiency-induced peripheral neuropathy (PN). OBJECTIVE: The present study aims to assess serum vitamin B12 levels in patients with T2DM on metformin. SUBJECTS AND METHODS: This cross-sectional study was conducted at a specialized endocrine outpatient clinic in Cumilla, Bangladesh, over six months from January 2020 to June 2020. Non-pregnant adults (≥18 years age) receiving metformin for T2DM for at least six months were evaluated for PN and assessed for serum B12 levels. RESULTS: Among 90 subjects evaluated, 28 (31.1%) had B12 deficiency and 6 (6.7%) had borderline B12 deficiency; 56 (62.2%) had normal B12 levels. Study subjects with subnormal B12 used metformin for a longer duration [8.5 (7.0-14.0) vs. 5.0 (2.25-10.0) years, median (IQR), P = 0.006], gram-years of metformin use was higher in them [12.0 (7.9-14.0) vs. 5.75 (2.0-13.6) years, median (IQR), P = 0.005] and they had a higher mean corpuscular volume [85.9±7.2 vs. 82.4±6.4 fL, mean±SD, P = 0.020] compared to those having normal B12 levels. Serum B12 levels had a strong negative correlation with duration of metformin use and gram-years of metformin use. B12 status did not influence the presence and severity of PN. CONCLUSIONS: A considerable number of patients with T2DM have subnormal B12 levels. Periodic screening for serum vitamin B12 level may be of clinical benefit in such patients.

Insulin Injection Practice and Injection Complications - Results from the Bangladesh Insulin Injection Technique Survey.

INTRODUCTION: Diabetes mellitus is highly prevalent in Bangladesh and insulin is often needed for diabetes control. We lack sufficient data on the insulin injection technique and injection-related complications. METHODS: The Bangladesh Insulin Injection Technique Survey (BIITS) was conducted in 2018 in 18 centres throughout Bangladesh, involving 847 patients taking insulin for at least 6 months. All of the study subjects were interviewed using a structured questionnaire focusing on key insulin injection parameters. RESULTS: The mean duration of insulin use by the study subjects was 3.84 (± 4.05) years and the mean daily dose of insulin was 41 (± 25) units. A total of 71.6% participants performed ≤2 injections/day and premixed insulins were the most commonly used insulins. Mean glycated haemoglobin (HbA1c) was 9.5% (± 2%). The proportion of syringe users and pen-device users was 68.1% and 31.9%, respectively. Most of the participants injected in the abdomen and rotated the injection site(s). The majority lifted the skinfold correctly and inserted the needle at a 90-degree angle, but their dwell times after injections were not adequate. A total of 9.2% of the subjects had injection-site lipohypertrophy (LH) and among them, 38.5% injected into the lesion. Patients with LH had higher HbA1c. Higher duration of insulin use (≥5 years), reusing needles more often (>10 times), and injecting at angles other than 90 degrees were independent predictors of LH. The incidences of hypoglycaemia (36.7%) and hyperglycaemia (67.4%) were very high, and subjects with LH had higher chances of both hypoglycaemia and hyperglycaemia. Though most (92.1%) of the patients received education about insulin injection initially, it was not repeated in the recent follow-up and was found to be ineffective. CONCLUSION: A huge gap between the insulin administration guidelines and current practice was observed in this study. Complications of insulin injections were also common. Healthcare providers should pay more attention to insulin education and re-evaluate injection practices from time to time.