Observational, Multicenter, Retrospective, Study on the Usage Patterns of the Fixed Dose Combination of Glimepiride, Metformin, and Voglibose in Type 2 Diabetes Management.

Objective This study aimed to evaluate and analyze the characteristics of Indian patients with type 2 diabetes mellitus (T2DM) in relation to the usage patterns of a fixed-dose combination (FDC) of glimepiride, metformin, and voglibose. Methods This retrospective, observational, multicentric analysis was conducted from March 2021 to September 2022. It involved adult patients (aged ≥18 years) with T2DM from 424 sites including a combination of hospitals and privately owned clinics across India to ensure comprehensive representation of the patient population The study included patients who had been treated with FDC of glimepiride, metformin, and voglibose of varying strengths for T2DM management. Data were collected through a pre-designed electronic form, which captured demographic details, medical history, T2DM history, and drug usage patterns from medical records. The collected data were then analyzed using descriptive statistical methods. Results This analysis encompassed a final cohort of 8,587 patients out of which 5,840 were males with a mean age of 54.91 years and a BMI of 28.41 kg/m2. Newly diagnosed T2DM cases were 35.23%, 54.79% had a family history, and 61.21% had risk factors such as smoking, sedentary lifestyle, and others. Dyslipidemia (13.94%) and neuropathy (14.48%) were common comorbidities. The most prescribed FDC was 1 mg glimepiride, 500 mg metformin, 0.2 mg voglibose (40.14%), the most preferred dosing frequency was once daily (52.92%) and the most common duration of treatment was one to three months (48.78%). Conclusion In routine Indian clinical practice, the triple drug FDC of 1 mg glimepiride, 500 mg metformin, and 0.2 mg voglibose, taken once daily for one to three months, was the most common treatment for both newly diagnosed and long-standing diabetes patients.

Digital Twin-Enabled Personalized Nutrition Improves Metabolic Dysfunction-Associated Fatty Liver Disease in Type 2 Diabetes: Results of a 1-Year Randomized Controlled Study.

OBJECTIVE: Postprandial hyperglycemia drives insulin resistance and inflammation, leading to metabolic dysfunction-associated fatty liver disease (MAFLD). Prediction of postprandial glycemic responses by digital twin (DT) technology can fashion a personalized nutrition, activity, and sleep to treat type 2 diabetes (T2D) and MAFLD. This study examines the effects of DT-enabled personalized nutrition, activity, and sleep on glycemic status, surrogate markers of MAFLD, and magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) in patients with T2D. METHODS: In an open-label randomized trial (2:1), 319 people with T2D were eligible to intervention (DT) or standard care (SC). DT patients followed personalized meal plans with foods suggested by artificial intelligence with least predicted postprandial glycemic response. The primary end point was to compare change in hemoglobin A1c (HbA1c) and medicine reduction between the DT and SC groups. Key secondary end points included remission to compare liver function test scores and visceral adiposity using MRI. RESULTS: HbA1C was significantly better for DT than for SC (-2.9 [1.8] vs -0.3 [1.2]; P < .001) at 1 year with 72.7% remission of T2D. In patients with abnormal baseline values, significant improvements were seen in DT vs SC patients from baseline to 1 year in nonalcoholic fatty liver disease liver fat score (mean [SD]; -2.5 [2.0] vs -0.1 [1.5]; P < .001) and nonalcoholic fatty liver disease fibrosis score (-1.20 [0.9] vs -0.1 [1.0]; P < .001), respectively. Improvements are seen with DT compared with SC in other liver fat, fibrosis score, and %liver fat by MRI-PDFF. CONCLUSION: At 1 year, DT-enabled personalized treatment significantly improved hyperglycemia and surrogate markers of MAFLD and MRI-PDFF.

Type 2 diabetes reversal with digital twin technology-enabled precision nutrition and staging of reversal: a retrospective cohort study.

BACKGROUND: Type 2 diabetes reversal has been viewed in the literature primarily as a dichotomous event (reversed or not reversed), even though this viewpoint may not be optimal for clinicians or patients. This cohort study's objectives were to define stages of type 2 diabetes reversal and measure changes in reversal stages before and after 90 days of digital twin-enabled precision nutrition therapy. METHODS: This study defines seven stages of diabetes reversal. The study is a retrospective pre/post comparison of changes in reversal stage, hemoglobin A1c (HbA1c), weight, body mass index (BMI), and other metrics measured before and after precision nutrition therapy. Reversal stages were defined as Stage 0: HbA1c < 5.7% without medication for > 1 year, Stage 1: HbA1c < 5.7% without medication for < 1 year, Stage 2: HbA1c < 6.5% without medication, Stage 3: estimated HbA1c (eA1c) between 5.7 and 6.4% without medication, Stage 4: estimated HbA1c (eA1c) between 5.7 and 6.4% with metformin monotherapy, Stage 5: dual oral therapy, Stage 6: > = 3 medications. RESULTS: Reversal stage information was available for 463 patients at baseline and 90 days. At baseline, the proportions of patients in each reversal stage were Stages 1 and 2: 0%, Stage 3: 1%, Stage 4: 8%, Stage 5: 6%, and Stage 6: 85%. After 90 days, the proportions in each reversal stage were Stage 1: 2%, Stage 2: 9%, Stage 3: 32%, Stage 4: 39%, Stage 5: 7%, and Stage 6: 11%, indicating significant progress. Reversal stage progression rates varied by patient subgroup. CONCLUSIONS: Type 2 diabetes patients reached differing reversal stages during 90 days of precision nutrition therapy. Use of reversal stages may benefit patients during therapy. TRIAL REGISTRATION: This was a retrospective study that was approved by the Medisys Clinisearch Ethical Review Board (without registration number) in 2019.

Retrospective study of glycemic variability, BMI, and blood pressure in diabetes patients in the Digital Twin Precision Treatment Program.

The objective of this retrospective observational cohort study was to measure glycemic variability and reductions in body mass index (BMI), blood pressure (BP), and use of antihypertensive medications in type 2 diabetes (T2D) patients participating in the digital twin-enabled Twin Precision Treatment (TPT) Program. Study participants included 19 females and 45 males with T2D who chose to participate in the TPT Program and adhered to program protocols. Nine additional enrollees were excluded due to major program non-adherence. Enrollees were required to have adequate hepatic and renal function, no myocardial infarction, stroke, or angina ≤ 90 days before enrollment, and no history of ketoacidosis or major psychiatric disorders. The TPT program uses Digital Twin technology, machine learning algorithms, and precision nutrition to aid treatment of patients with T2D. Each study participant had ≥ 3 months of follow-up. Outcome measures included glucose percentage coefficient of variation (%CV), low blood glucose index (LBGI), high blood glucose index (HBGI), systolic and diastolic BP, number of antihypertensive medications, and BMI. Sixty-four patients participated in the program. Mean (± standard deviation) %CV, LBGI, and HBGI values were low (17.34 ± 4.35, 1.37 ± 1.37, and 2.13 ± 2.79, respectively) throughout the 90-day program. BMI decreased from 29.23 ± 5.83 at baseline to 27.43 ± 5.25 kg/m2. Systolic BP fell from 134.72 ± 17.73 to 124.58 ± 11.62 mm Hg. Diastolic BP decreased from 83.95 ± 10.20 to 80.33 ± 7.04 mm Hg. The percent of patients taking antihypertensive medications decreased from 35.9% at baseline to 4.7% at 90 days. During 90 days of the TPT Program, patients achieved low glycemic variability and significant reductions in BMI and BP. Antihypertensive medication use was eliminated in nearly all patients. Future research will focus on randomized case-control comparisons.

Clinical data analysis of telmisartan for hypertension management in Indian population.

It is of interest to evaluate the clinical characteristics, treatment patterns, clinical effectiveness, and safety of telmisartan as a monotherapy or as part of combination therapy in Indian adults (>18 years old) with hypertension. All patients were receiving telmisartan as monotherapy, or as a combination therapy for hypertension management. Demographics, risk factors, existing comorbidity, and ongoing medical therapies were retrieved from the patients' medical records. A total of 8607 patients with hypertension (median age, 51.0 years) were part of the study. The gender distribution suggested, 5534(64.3%) patients were male, and 3073 (35.7%) were female patients. The excess salt intake (39.0%) was the most common risk factor according to the results. The analysis revealed telmisartan dual therapy (57.9%) as the most prescribed therapy, followed by monotherapy (32.5%), and triple therapy (9.6%). Further, telmisartan 40mg (21.3%) and telmisartan 40mg plus amlodipine 5mg (17.6%) were the most commonly prescribed therapies. The data suggested that only 17.2% of patients required dose titration. The mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg) were significantly decreased with monotherapy (mean change: 19.8 [15.1] mmHg and 8.8[8.2] mmHg), dual therapy (mean change: 23.7 [16.6] mmHg and 10.3[8.5] mmHg), and triple therapy (mean change: 28.6 [19.0] mmHg and 12.1[10.8] mmHg) after the treatment (P<0.001). A total of 98.4% of the patients were compliant, and 97.6% achieved the target blood pressure goal with telmisartan-based therapy. There were 157 adverse events reported altogether. The Physicians' global evaluation of efficacy and tolerability showed the majority of the patients receiving telmisartan-based therapy on a good to excellent scale. Telmisartan used as a monotherapeutic agent or as a part of combination therapy was successful and effective in reducing blood pressure and achieving the blood pressure target. Irrespective of the patient's age, duration, and stages of hypertension, the study resulted in a good to excellent scale in efficacy and tolerability in the Indian patients having hypertension.

Reducing HbA1c in Type 2 Diabetes Using Digital Twin Technology-Enabled Precision Nutrition: A Retrospective Analysis.

INTRODUCTION: The objective of this study was to examine changes in hemoglobin A1c (HbA1c), anti-diabetic medication use, insulin resistance, and other ambulatory glucose profile metrics between baseline and after 90 days of participation in the Twin Precision Nutrition (TPN) Program enabled by Digital Twin Technology. METHODS: This was a retrospective study of patients with type 2 diabetes who participated in the TPN Program and had at least 3 months of follow-up. The TPN machine learning algorithm used daily continuous glucose monitor (CGM) and food intake data to provide guidelines that would enable individual patients to avoid foods that cause blood glucose spikes and to replace them with foods that do not produce spikes. Physicians with access to daily CGM data titrated medications and monitored patient conditions. RESULTS: Of the 89 patients who initially enrolled in the TPN Program, 64 patients remained in the program and adhered to it for at least 90 days; all analyses were performed on these 64 patients. At the 90-day follow-up assessment, mean (± standard deviation) HbA1c had decreased from 8.8 ± 2.2% at baseline by 1.9 to 6.9 ± 1.1%, mean weight had decreased from 79.0 ± 16.2 kg at baseline to 74.2 ± 14.7 kg, and mean fasting blood glucose had fallen from 151.2 ± 45.0 mg/dl at baseline to 129.1 ± 36.7 mg/dl. Homeostatic model assessment of insulin resistance (HOMA-IR) had decreased by 56.9% from 7.4 ± 3.5 to 3.2 ± 2.8. At the 90-day follow-up assessment, all 12 patients who were on insulin had stopped taking this medication; 38 of the 56 patients taking metformin had stopped metformin; 26 of the 28 patients on dipeptidyl peptidase-4 (DPP-4) inhibitors discontinued DPP-4 inhibitors; all 13 patients on alpha-glucosidase inhibitors discontinued these inhibitors; all 34 patients on sulfonylureas were able to stop taking these medications; two patients stopped taking pioglitazone; all ten patients on sodium-glucose cotransporter-2 (SGLT2) inhibitors stopped taking SGLT2 inhibitors; and one patient stopped taking glucagon-like peptide-1 analogues. CONCLUSION: The results provide evidence that daily precision nutrition guidance based on CGM, food intake data, and machine learning algorithms can benefit patients with type 2 diabetes. Adherence for 3 months to the TPN Program resulted in patients achieving a 1.9 percentage point decrease in HbA1c, a 6.1% drop in weight, a 56.9% reduction in HOMA-IR, a significant decline in glucose time below range, and, in most patients, the elimination of diabetes medication use.

Blood pressure control with a single-pill combination of indapamide sustained-release and amlodipine in patients with hypertension: the EFFICIENT study.

OBJECTIVE: Despite antihypertensive treatment, most hypertensive patients still have high blood pressure (BP), notably high systolic blood pressure (SBP). The EFFICIENT study examines the efficacy and acceptability of a single-pill combination of sustained-release (SR) indapamide, a thiazide-like diuretic, and amlodipine, a calcium channel blocker (CCB), in the management of hypertension. METHODS: Patients who were previously uncontrolled on CCB monotherapy (BP≥140/90 mm Hg) or were previously untreated with grade 2 or 3 essential hypertension (BP≥160/100 mm Hg) received a single-pill combination tablet containing indapamide SR 1.5 mg and amlodipine 5 mg daily for 45 days, in this multicenter prospective phase 4 study. The primary outcome was mean change in BP from baseline; percentage of patients achieving BP control (BP<140/90 mm Hg) was a secondary endpoint. SBP reduction (ΔSBP) versus diastolic BP reduction (ΔDBP) was evaluated (ΔSBP/ΔDBP) from baseline to day 45. Safety and tolerability were also assessed. RESULTS: Mean baseline BP of 196 patients (mean age 52.3 years) was 160.2/97.9 mm Hg. After 45 days, mean SBP decreased by 28.5 mm Hg (95% CI, 26.4 to 30.6), while diastolic BP decreased by 15.6 mm Hg (95% CI, 14.5 to 16.7). BP control (<140/90 mm Hg) was achieved in 85% patients. ΔSBP/ΔDBP was 1.82 in the overall population. Few patients (n = 3 [2%]) reported side effects, and most (n = 194 [99%]) adhered to treatment. CONCLUSION: In patients who were previously uncontrolled on CCB monotherapy or untreated with grade 2 or 3 hypertension, single-pill combination indapamide SR/amlodipine reduced BP effectively--especially SBP--over 45 days, and was safe and well tolerated. TRIAL REGISTRATION: Clinical Trial Registry-India CTRI/2010/091/000114.

Beneficial effects of once-daily lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin (GetGoal-S).

AIMS: To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) ± metformin. METHODS: In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 µg once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs ± metformin. Primary outcome was change in HbA1c from baseline to Week 24. RESULTS: Lixisenatide provided a significant reduction in HbA1c at Week 24 versus placebo (LS mean: -0.85% vs. -0.10%; p<0.0001) and more patients achieved HbA1c <7.0% (36.4% vs. 13.5%; p<0.0001). Lixisenatide significantly lowered FPG and body weight versus placebo. In breakfast meal test patients, lixisenatide reduced 2-hour PPG versus placebo (LS mean: -111.48 vs. -3.80 mg/dL [-6.19 vs. -0.21 mmol/L]; p<0.0001) and glucose excursion (-94.11 vs. +6.24 mg/dL [-5.22 vs. +0.35 mmol/L]), and reduced 2-hour glucagon, insulin, proinsulin, and C-peptide. The percentage of AEs was 68.3% for lixisenatide and 61.1% for placebo; and for SAEs: 3.5% versus 5.6%, respectively. Lixisenatide did not significantly increase symptomatic hypoglycemia versus placebo (15.3% vs. 12.3%, respectively); one severe episode of hypoglycemia was reported with lixisenatide. CONCLUSIONS: Once-daily lixisenatide significantly improved glycemic control, with a pronounced postprandial effect, without significant increase in symptomatic/severe hypoglycemia risk and with weight loss over 24 weeks.