Introduction: While ample evidence on improved glycemic control, weight reduction, and lowered bl... more Introduction: While ample evidence on improved glycemic control, weight reduction, and lowered blood pressure (BP) with sodium-glucose cotransporter type 2 inhibitors (SGLT2is) exists, real-world data on the potential benefit of SGLT2i on the diabetic population in the Middle East are lacking. The aim of our study was to describe the glycemic control, changes in body weight, body mass index (BMI), lipid profile, and BPs in patients receiving dapagliflozin with other antidiabetic medication. Methods: The REWARD study was a multicenter, post-authorization, prospective, open-label, noninterventional, real-world, cohort study. We enrolled 511 adult, type 2 diabetes mellitus patients on antidiabetic medications. These patients were started on dapagliflozin and followed up for 1 year to assess changes in their clinical and laboratory outcomes. Results: The mean HbA1c decreased significantly from 8.5 ± 1.6% at baseline to 7.6 ± 1.3% after 12 months (p value <0.001), with an absolute cha...
International Journal of Diabetes and Clinical Research, Dec 31, 2017
Heart Rate Recovery (HRR) has been associated with cardiovascular and all-cause mortality in both... more Heart Rate Recovery (HRR) has been associated with cardiovascular and all-cause mortality in both healthy individuals and those with diabetes. We examined the association between Hemoglobin A1C (HbA1c) and post-exercise HRR in patients with diabetes. Participants who were free from known cardiac disease or severe orthopedic problems referred to an exercise specialist for a fitness assessment. All participants underwent a graded exercise test using a standard Balke-ware protocol. HRR defined as the decrease in heart rate from peak exercise after one minute of a cool down walk at 2 mph and 0% incline. The most recent HbA1c (within three months) recorded for each patient. This study included 411 individuals with diabetes [age 45 ± 10, 269 (65%) males, 375 (91%) with type 2 diabetes, BMI 31 ± 6, 49% with BMI > 30 kg/m 2 ]. The mean HbA1c was 7.3% ± 1.6 (56 mmol/mol). The participants divided into 4 equal cohorts based on the quartiles of HRR. Using multiple logistic regression, adjusting for age, gender, BMI, metabolic equivalent, beta blocker usage, hypertension, and duration of diabetes, there was a significant association between HbA1c and odds of having a HRR in the lowest quartile, such that for every unit increase in HbA1c, there was 13% increase in odds of being in the lowest HRR quartile (adjusted odds ratio 1.125 [1.002, 1.264]). Among diabetic patients without known cardiac disease, poor glycemic control as measured by elevated HbA1c is significantly associated with decreased post-exercise HRR.
Innovations in syringe and pen needle (PN) technology over the last 100 years have led to importa... more Innovations in syringe and pen needle (PN) technology over the last 100 years have led to important advances in insulin delivery for people with diabetes, paralleling the strides made in developing recombinant DNA human insulin and insulin analogs with varying onset and duration of action. In this review, the history of advances in insulin delivery is described, focusing on progress in syringe, needle, and PN technologies. The early glass and metal syringes that required sterilization by boiling have been replaced by disposable, single-use syringes or pens with clear labeling for precise insulin dosing. The early needles ranging in length from 19 to 26 mm that required manual sharpening against a whetstone have been replaced by syringe needles of 6 mm and PNs of 4 mm in length as slender as 34 gauge. Imaging studies using ultrasound and computed tomography measured the thickness of skin and subcutaneous tissue layers to show feasibility of targeted insulin administration with shorte...
Background. Transcription factor 7-like 2 gene (TCF7L2) and peroxisome proliferator-activated rec... more Background. Transcription factor 7-like 2 gene (TCF7L2) and peroxisome proliferator-activated receptors-2 (PPAR-2) have a profound effect on the incidence of type 2 diabetes mellitus (T2DM) and had previously been found to be associated with T2DM risk in various ppopulations. However, studies in the Arab population are inconsistent. We conducted a case control study to confirm the association of variants rs10885409 of TCF7L2 and Pro12Ala (rs1801282) of PPAR-2 with risk of T2DM and related complications in Emirati population of Arab origin. We also investigated the interaction of these associations with obesity status. Methods. DNA was extracted from the saliva samples of 272 T2DM patients and 216 nondiabetic Emiratis. Genotyping for rs10885409 (TCF7L2) and rs1801282 (PPAR-2 P12A) variants was accomplished with a TaqMan assay. The subgroups were constituted according to obesity status. Results. In the nonobese group, the rs10885409 C allele in the recessive model was significantly as...
Rapid urbanisation and socioeconomic development in the United Arab Emirates (UAE) have led to th... more Rapid urbanisation and socioeconomic development in the United Arab Emirates (UAE) have led to the widespread adoption of a sedentary lifestyle and Westernised diet in the local population and consequently a high prevalence of obesity and diabetes. In 2019, International Diabetes Federation statistics reported a diabetes prevalence rate of 16.3% for the adult population in the UAE. In view of the wealth of recent literature on diabetes care and new pharmacotherapeutics, the Emirates Diabetes Society convened a panel of experts to update existing local guidelines with international management recommendations. The goal is to improve the standard of care for people with diabetes through increased awareness of these management practices among healthcare providers licensed by national health authorities. These consensus guidelines address the screening, diagnosis and management of type 2 diabetes mellitus in adults including individuals at risk of developing the disease.
Management guidelines continue to identify metformin as initial pharmacologic antidiabetic therap... more Management guidelines continue to identify metformin as initial pharmacologic antidiabetic therapy of choice for people with type 2 diabetes without contraindications, despite recent randomized trials that have demonstrated significant improvements in cardiovascular outcomes with newer classes of antidiabetic therapies. The purpose of
Current and future estimates of the burden of diabetes in the Middle East and North Africa (MENA)... more Current and future estimates of the burden of diabetes in the Middle East and North Africa (MENA) region are among the highest in the world. VISION, an 18-month observational study, explored patterns of insulin initiation and intensification in T2DM patients in the MENA region. Methods: 1192 patients aged !18 years were enrolled from Algeria, Egypt, Saudi Arabia and the UAE. Treating physicians recorded participants' data. Patient-reported outcomes (PROs) were assessed using questionnaires completed by participants. Results: 67.6% patients had HbA1c !9% at insulin initiation, with a mean HbA1c of 9.9%, despite 68.3% patients being on !2 oral anti-diabetics, indicating a significant delay in insulin initiation. Basal insulin was initiated in 50.6% and premixed insulin in 46.3% patients. After 18 months, changes in insulin therapy were observed in 33.7% patients, while 39.6% patients achieved HbA1c levels of <7.5%. The proportion of patients completely satisfied with their insulin treatment, and the QoL increased over the study course. Conclusion: Results support that timely initiation and early intensification of insulin therapy are necessary in the region to achieve adequate and timely glycemic control and to prevent diabetic complications.
Most data on the burden of diabetes and prediabetes are from countries where local infrastructure... more Most data on the burden of diabetes and prediabetes are from countries where local infrastructure can support reliable estimates of the burden of non-communicable diseases. Countries in the Middle East and Africa, together with Russia, have a total population of almost 2 billion, but have been relatively overlooked by authors in this field. We reviewed the prevalence and drivers of prediabetes and diabetes across this large region. A large, and variable, burden of dysglycaemia exists, especially in Middle Eastern and North African countries, associated with high levels of obesity and sedentariness, with a generally lower prevalence in most other parts of Africa. The design and size of studies are highly variable, and more research to quantify the scale of the problem is needed. Local barriers to care relating to issues concerned with gender, consanguinity, lack of understanding of diabetes, lack of understanding of obesity as a health issue, and limited resource at a national level ...
The American Diabetes Association and the European Association for the Study of Diabetes guidelin... more The American Diabetes Association and the European Association for the Study of Diabetes guidelines recommend to individualize treatment targets/strategies in inadequately controlled patients by lifestyle management and glucose-lowering drugs to decrease the burden of diabetes-related complications. This real-world practice study aimed to assess predictive factors for achieving the glycemic hemoglobin A1c (HbA1c) at 6 months as targeted by the treating physician in adults with type 2 diabetes who required initiation of basal insulin, initiation of bolus insulin, or modification from basal or premixed insulin to new insulin regimen containing insulin glargine and/or insulin glulisine. This was an international, multicenter, observational survey with 12-month follow-up time in adults with type 2 diabetes inadequately controlled conducted in 10 developing countries. Overall, 2704 patients (mean age: 54.6 years, body mass index: 28.7 kg/m; Caucasian: 46.1%, type 2 diabetes duration: 10....
Diabetes research and clinical practice, Jan 24, 2017
To determine the prevalence of diabetes self-care activities among type 2 diabetes patients and e... more To determine the prevalence of diabetes self-care activities among type 2 diabetes patients and examine the association between socio-demographic and clinical parameters, diabetes self-care activities, and glycemic control among type 2 diabetes patients. A cross sectional study was conducted among patients with diabetes (n = 123) at the Sultan Bin Abdulaziz Humanitarian City (SBAHC). A regression model was used to examine the variables that predicted glycemic control. Moreover, a regression analysis examining the effect of each self-efficacy subscale on its respective diabetes self -management (DSM) behavior was carried out. The most frequently reported DSM behaviors were foot care followed by medication taking self-management behavior. The least frequently reported DSM behaviors were exercise self-management behavior and blood sugar testing behavior. Self-efficacy was associated with higher levels of diet, exercise, blood sugar testing, and medication taking self-management behavio...
Aims: There is a large population of people with type 2 diabetes mellitus (T2DM) who are Muslim a... more Aims: There is a large population of people with type 2 diabetes mellitus (T2DM) who are Muslim and fast during Ramadan. Changes in the pattern and amount of meal and fluid intake during Ramadan, in addition to the long fasting hours, may increase the risk of hypoglycaemia, hyperglycaemia, and dehydration. The Canagliflozin in Ramadan Tolerance Observational Study (CRATOS) evaluated the tolerability of canagliflozin, a sodium glucose co-transporter 2 inhibitor, compared with sulphonylureas among patients with T2DM who fast during Ramadan. Methods: This non-randomised, parallel-cohort, prospective, comparative, observational study was conducted in the Middle East during Ramadan and enrolled patients who were taking canagliflozin (n=162) or any sulphonylurea (n=159) added to metformin±dipeptidyl peptidase-4 inhibitor. The proportion of patients who experienced hypoglycaemia events was assessed as the primary end-point. Between-cohort comparisons were adjusted using propensity score analysis. Results: During Ramadan, fewer patients experienced symptomatic hypoglycaemia with canagliflozin vs sulphonylurea (adjusted odds ratio: 0.273 [95% CI: 0.104, 0.719]). Of hypoglycaemia events for which blood glucose was measured, two of six with canagliflozin and 27 of 37 with sulphonylurea were confirmed by blood glucose <3.9 mmol/L. More patients treated with canagliflozin experienced volume depletion events compared with sulphonylurea (adjusted odds ratio: 3.5 [95% CI: 1.3, 9.2]). Missed fasting days were few and medication adherence was high in both groups. No patients treated with canagliflozin and 9.4% treated with sulphonylurea adjusted their medication dose near the beginning of Ramadan. Both treatments were generally well tolerated, with low rates of adverse events and no serious adverse events in either group. Conclusions: Overall, these findings support the use of canagliflozin for the treatment of adults with T2DM who fast during Ramadan. ClinicalTrials.gov Identifier: NCT02737657. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, 2016
Background: VIRTUE was a prospective, observational study assessing the effectiveness and safety ... more Background: VIRTUE was a prospective, observational study assessing the effectiveness and safety of vildagliptin vs sulfonylureas (SUs) (both as monotherapy and in combination with metformin) in patients with type 2 diabetes mellitus who fasted during Ramadan. A post hoc analysis was carried out to assess the effect of treatment with/without metformin and age (,65 years or $65 years). Patients and methods: Patients were recruited from the Middle East and Asia. The primary end point was proportion of patients with one or more hypoglycemic event (HE) during Ramadan. Secondary end points included change from baseline in glycated hemoglobin (HbA1c), body weight, and safety. Results: Overall, 684 patients received vildagliptin and 631 received SUs. Most patients received dual therapy with metformin (n=1,148) and were aged ,65 years (n=1,189). A few patients experienced one or more HE with vildagliptin vs SU monotherapy (6.5% vs 14.5%) and with vildagliptin + metformin vs SUs + metformin (5.3% vs 20.6%); the latter achieved statistical significance (P,0.001) in both age subgroups (,65 years: 5.5% vs 18.4%, P,0.001; $65 years: 2.8% vs 30.9%, P,0.001). Vildagliptin was associated with numerically greater HbA1c and body weight reductions vs SUs, regardless of the therapy type or age. A higher proportion of SU-vs vildagliptin-treated patients experienced adverse events across all subgroups. Conclusion: A few patients experienced HEs with vildagliptin vs SUs regardless of age, and in patients on dual therapy. Vildagliptin ± metformin was also associated with good glycemic and weight control and was well tolerated. Vildagliptin might be a useful treatment option for patients with type 2 diabetes mellitus, particularly high-risk populations such as the elderly fasting during Ramadan.
Introduction: While ample evidence on improved glycemic control, weight reduction, and lowered bl... more Introduction: While ample evidence on improved glycemic control, weight reduction, and lowered blood pressure (BP) with sodium-glucose cotransporter type 2 inhibitors (SGLT2is) exists, real-world data on the potential benefit of SGLT2i on the diabetic population in the Middle East are lacking. The aim of our study was to describe the glycemic control, changes in body weight, body mass index (BMI), lipid profile, and BPs in patients receiving dapagliflozin with other antidiabetic medication. Methods: The REWARD study was a multicenter, post-authorization, prospective, open-label, noninterventional, real-world, cohort study. We enrolled 511 adult, type 2 diabetes mellitus patients on antidiabetic medications. These patients were started on dapagliflozin and followed up for 1 year to assess changes in their clinical and laboratory outcomes. Results: The mean HbA1c decreased significantly from 8.5 ± 1.6% at baseline to 7.6 ± 1.3% after 12 months (p value <0.001), with an absolute cha...
International Journal of Diabetes and Clinical Research, Dec 31, 2017
Heart Rate Recovery (HRR) has been associated with cardiovascular and all-cause mortality in both... more Heart Rate Recovery (HRR) has been associated with cardiovascular and all-cause mortality in both healthy individuals and those with diabetes. We examined the association between Hemoglobin A1C (HbA1c) and post-exercise HRR in patients with diabetes. Participants who were free from known cardiac disease or severe orthopedic problems referred to an exercise specialist for a fitness assessment. All participants underwent a graded exercise test using a standard Balke-ware protocol. HRR defined as the decrease in heart rate from peak exercise after one minute of a cool down walk at 2 mph and 0% incline. The most recent HbA1c (within three months) recorded for each patient. This study included 411 individuals with diabetes [age 45 ± 10, 269 (65%) males, 375 (91%) with type 2 diabetes, BMI 31 ± 6, 49% with BMI > 30 kg/m 2 ]. The mean HbA1c was 7.3% ± 1.6 (56 mmol/mol). The participants divided into 4 equal cohorts based on the quartiles of HRR. Using multiple logistic regression, adjusting for age, gender, BMI, metabolic equivalent, beta blocker usage, hypertension, and duration of diabetes, there was a significant association between HbA1c and odds of having a HRR in the lowest quartile, such that for every unit increase in HbA1c, there was 13% increase in odds of being in the lowest HRR quartile (adjusted odds ratio 1.125 [1.002, 1.264]). Among diabetic patients without known cardiac disease, poor glycemic control as measured by elevated HbA1c is significantly associated with decreased post-exercise HRR.
Innovations in syringe and pen needle (PN) technology over the last 100 years have led to importa... more Innovations in syringe and pen needle (PN) technology over the last 100 years have led to important advances in insulin delivery for people with diabetes, paralleling the strides made in developing recombinant DNA human insulin and insulin analogs with varying onset and duration of action. In this review, the history of advances in insulin delivery is described, focusing on progress in syringe, needle, and PN technologies. The early glass and metal syringes that required sterilization by boiling have been replaced by disposable, single-use syringes or pens with clear labeling for precise insulin dosing. The early needles ranging in length from 19 to 26 mm that required manual sharpening against a whetstone have been replaced by syringe needles of 6 mm and PNs of 4 mm in length as slender as 34 gauge. Imaging studies using ultrasound and computed tomography measured the thickness of skin and subcutaneous tissue layers to show feasibility of targeted insulin administration with shorte...
Background. Transcription factor 7-like 2 gene (TCF7L2) and peroxisome proliferator-activated rec... more Background. Transcription factor 7-like 2 gene (TCF7L2) and peroxisome proliferator-activated receptors-2 (PPAR-2) have a profound effect on the incidence of type 2 diabetes mellitus (T2DM) and had previously been found to be associated with T2DM risk in various ppopulations. However, studies in the Arab population are inconsistent. We conducted a case control study to confirm the association of variants rs10885409 of TCF7L2 and Pro12Ala (rs1801282) of PPAR-2 with risk of T2DM and related complications in Emirati population of Arab origin. We also investigated the interaction of these associations with obesity status. Methods. DNA was extracted from the saliva samples of 272 T2DM patients and 216 nondiabetic Emiratis. Genotyping for rs10885409 (TCF7L2) and rs1801282 (PPAR-2 P12A) variants was accomplished with a TaqMan assay. The subgroups were constituted according to obesity status. Results. In the nonobese group, the rs10885409 C allele in the recessive model was significantly as...
Rapid urbanisation and socioeconomic development in the United Arab Emirates (UAE) have led to th... more Rapid urbanisation and socioeconomic development in the United Arab Emirates (UAE) have led to the widespread adoption of a sedentary lifestyle and Westernised diet in the local population and consequently a high prevalence of obesity and diabetes. In 2019, International Diabetes Federation statistics reported a diabetes prevalence rate of 16.3% for the adult population in the UAE. In view of the wealth of recent literature on diabetes care and new pharmacotherapeutics, the Emirates Diabetes Society convened a panel of experts to update existing local guidelines with international management recommendations. The goal is to improve the standard of care for people with diabetes through increased awareness of these management practices among healthcare providers licensed by national health authorities. These consensus guidelines address the screening, diagnosis and management of type 2 diabetes mellitus in adults including individuals at risk of developing the disease.
Management guidelines continue to identify metformin as initial pharmacologic antidiabetic therap... more Management guidelines continue to identify metformin as initial pharmacologic antidiabetic therapy of choice for people with type 2 diabetes without contraindications, despite recent randomized trials that have demonstrated significant improvements in cardiovascular outcomes with newer classes of antidiabetic therapies. The purpose of
Current and future estimates of the burden of diabetes in the Middle East and North Africa (MENA)... more Current and future estimates of the burden of diabetes in the Middle East and North Africa (MENA) region are among the highest in the world. VISION, an 18-month observational study, explored patterns of insulin initiation and intensification in T2DM patients in the MENA region. Methods: 1192 patients aged !18 years were enrolled from Algeria, Egypt, Saudi Arabia and the UAE. Treating physicians recorded participants' data. Patient-reported outcomes (PROs) were assessed using questionnaires completed by participants. Results: 67.6% patients had HbA1c !9% at insulin initiation, with a mean HbA1c of 9.9%, despite 68.3% patients being on !2 oral anti-diabetics, indicating a significant delay in insulin initiation. Basal insulin was initiated in 50.6% and premixed insulin in 46.3% patients. After 18 months, changes in insulin therapy were observed in 33.7% patients, while 39.6% patients achieved HbA1c levels of <7.5%. The proportion of patients completely satisfied with their insulin treatment, and the QoL increased over the study course. Conclusion: Results support that timely initiation and early intensification of insulin therapy are necessary in the region to achieve adequate and timely glycemic control and to prevent diabetic complications.
Most data on the burden of diabetes and prediabetes are from countries where local infrastructure... more Most data on the burden of diabetes and prediabetes are from countries where local infrastructure can support reliable estimates of the burden of non-communicable diseases. Countries in the Middle East and Africa, together with Russia, have a total population of almost 2 billion, but have been relatively overlooked by authors in this field. We reviewed the prevalence and drivers of prediabetes and diabetes across this large region. A large, and variable, burden of dysglycaemia exists, especially in Middle Eastern and North African countries, associated with high levels of obesity and sedentariness, with a generally lower prevalence in most other parts of Africa. The design and size of studies are highly variable, and more research to quantify the scale of the problem is needed. Local barriers to care relating to issues concerned with gender, consanguinity, lack of understanding of diabetes, lack of understanding of obesity as a health issue, and limited resource at a national level ...
The American Diabetes Association and the European Association for the Study of Diabetes guidelin... more The American Diabetes Association and the European Association for the Study of Diabetes guidelines recommend to individualize treatment targets/strategies in inadequately controlled patients by lifestyle management and glucose-lowering drugs to decrease the burden of diabetes-related complications. This real-world practice study aimed to assess predictive factors for achieving the glycemic hemoglobin A1c (HbA1c) at 6 months as targeted by the treating physician in adults with type 2 diabetes who required initiation of basal insulin, initiation of bolus insulin, or modification from basal or premixed insulin to new insulin regimen containing insulin glargine and/or insulin glulisine. This was an international, multicenter, observational survey with 12-month follow-up time in adults with type 2 diabetes inadequately controlled conducted in 10 developing countries. Overall, 2704 patients (mean age: 54.6 years, body mass index: 28.7 kg/m; Caucasian: 46.1%, type 2 diabetes duration: 10....
Diabetes research and clinical practice, Jan 24, 2017
To determine the prevalence of diabetes self-care activities among type 2 diabetes patients and e... more To determine the prevalence of diabetes self-care activities among type 2 diabetes patients and examine the association between socio-demographic and clinical parameters, diabetes self-care activities, and glycemic control among type 2 diabetes patients. A cross sectional study was conducted among patients with diabetes (n = 123) at the Sultan Bin Abdulaziz Humanitarian City (SBAHC). A regression model was used to examine the variables that predicted glycemic control. Moreover, a regression analysis examining the effect of each self-efficacy subscale on its respective diabetes self -management (DSM) behavior was carried out. The most frequently reported DSM behaviors were foot care followed by medication taking self-management behavior. The least frequently reported DSM behaviors were exercise self-management behavior and blood sugar testing behavior. Self-efficacy was associated with higher levels of diet, exercise, blood sugar testing, and medication taking self-management behavio...
Aims: There is a large population of people with type 2 diabetes mellitus (T2DM) who are Muslim a... more Aims: There is a large population of people with type 2 diabetes mellitus (T2DM) who are Muslim and fast during Ramadan. Changes in the pattern and amount of meal and fluid intake during Ramadan, in addition to the long fasting hours, may increase the risk of hypoglycaemia, hyperglycaemia, and dehydration. The Canagliflozin in Ramadan Tolerance Observational Study (CRATOS) evaluated the tolerability of canagliflozin, a sodium glucose co-transporter 2 inhibitor, compared with sulphonylureas among patients with T2DM who fast during Ramadan. Methods: This non-randomised, parallel-cohort, prospective, comparative, observational study was conducted in the Middle East during Ramadan and enrolled patients who were taking canagliflozin (n=162) or any sulphonylurea (n=159) added to metformin±dipeptidyl peptidase-4 inhibitor. The proportion of patients who experienced hypoglycaemia events was assessed as the primary end-point. Between-cohort comparisons were adjusted using propensity score analysis. Results: During Ramadan, fewer patients experienced symptomatic hypoglycaemia with canagliflozin vs sulphonylurea (adjusted odds ratio: 0.273 [95% CI: 0.104, 0.719]). Of hypoglycaemia events for which blood glucose was measured, two of six with canagliflozin and 27 of 37 with sulphonylurea were confirmed by blood glucose <3.9 mmol/L. More patients treated with canagliflozin experienced volume depletion events compared with sulphonylurea (adjusted odds ratio: 3.5 [95% CI: 1.3, 9.2]). Missed fasting days were few and medication adherence was high in both groups. No patients treated with canagliflozin and 9.4% treated with sulphonylurea adjusted their medication dose near the beginning of Ramadan. Both treatments were generally well tolerated, with low rates of adverse events and no serious adverse events in either group. Conclusions: Overall, these findings support the use of canagliflozin for the treatment of adults with T2DM who fast during Ramadan. ClinicalTrials.gov Identifier: NCT02737657. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, 2016
Background: VIRTUE was a prospective, observational study assessing the effectiveness and safety ... more Background: VIRTUE was a prospective, observational study assessing the effectiveness and safety of vildagliptin vs sulfonylureas (SUs) (both as monotherapy and in combination with metformin) in patients with type 2 diabetes mellitus who fasted during Ramadan. A post hoc analysis was carried out to assess the effect of treatment with/without metformin and age (,65 years or $65 years). Patients and methods: Patients were recruited from the Middle East and Asia. The primary end point was proportion of patients with one or more hypoglycemic event (HE) during Ramadan. Secondary end points included change from baseline in glycated hemoglobin (HbA1c), body weight, and safety. Results: Overall, 684 patients received vildagliptin and 631 received SUs. Most patients received dual therapy with metformin (n=1,148) and were aged ,65 years (n=1,189). A few patients experienced one or more HE with vildagliptin vs SU monotherapy (6.5% vs 14.5%) and with vildagliptin + metformin vs SUs + metformin (5.3% vs 20.6%); the latter achieved statistical significance (P,0.001) in both age subgroups (,65 years: 5.5% vs 18.4%, P,0.001; $65 years: 2.8% vs 30.9%, P,0.001). Vildagliptin was associated with numerically greater HbA1c and body weight reductions vs SUs, regardless of the therapy type or age. A higher proportion of SU-vs vildagliptin-treated patients experienced adverse events across all subgroups. Conclusion: A few patients experienced HEs with vildagliptin vs SUs regardless of age, and in patients on dual therapy. Vildagliptin ± metformin was also associated with good glycemic and weight control and was well tolerated. Vildagliptin might be a useful treatment option for patients with type 2 diabetes mellitus, particularly high-risk populations such as the elderly fasting during Ramadan.
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