Mean Change In HbA1c Research Articles

Safety and effectiveness of linagliptin in Korean patients with type 2 diabetes: A postmarketing surveillance study.

We designed a postmarketing surveillance study of linagliptin for patients with type 2 diabetes (T2D) in Korea. This prospective, observational, multicentre study investigated the safety and glycaemic effectiveness of linagliptin as monotherapy or combination therapy with other antidiabetic drugs in routine clinical practice. Endpoints were the incidence of adverse drug reactions (ADRs) and the change in HbA1c. Overall, 3119 and 2171 patients were included in the safety and effectiveness analysis sets, respectively. A total of 56 patients (1.8%) experienced ADRs. The most common ADR was gastrointestinal disorders (0.7%), followed by metabolism and nutrition disorders (0.5%). ADRs of special interest, including pancreatic diseases, cardiac diseases and hypoglycaemia, occurred in 12 patients, 11 of whom had hypoglycaemia, while one had a skin lesion. Mean HbA1c change during the study period was -0.8%. Lower body mass index, shorter diabetes duration and higher baseline HbA1c were independently associated with a better effectiveness, while the presence of diabetic complications, dyslipidaemia and the use of sulphonylureas were associated with a poor response. In conclusion, linagliptin showed an excellent safety profile and glycaemic effectiveness in Korean patients with T2D.

Semaglutide Once Weekly In Persons with Type 2 Diabetes: Real-World Analysis of the Colombian Diabetes Registry (COL-REAL 1 Study)

Background: Glucagon like peptide-1 receptor agonists (GLP-1 RA) are injectable glucose lowering therapies that induce insulin secretion, control glucagon secretion, delay gastric emptying and reduce appetite. Semaglutide, in the subcutaneous formulation, became the newest GLP-1 RA available in Colombia from 2020, nevertheless, to better understand the impact of semaglutide treatment in a real-world setting, we will examine the short-term changes in metabolic, cardiovascular and body weight control in adults with diabetes in Colombia who initiate once-weekly semaglutide. Methods: This is a retro-prospective observational study used data from adults patients in Cali-Colombia with T2D who were naïve to GLP-1 RA therapy, initiated semaglutide therapy as usual standard of care between February and November 2020, who maintained semaglutide therapy during followup, were eligible for analysis. The primary outcome was mean change in HbA1c and weight at three to six-month follow-up. Results: In the final analytic cohort (n=30), there was a statistically significant reduction at three month in HbA1c (%) of -2.43 ± 1.89% (mean ± SD) (p<0.001) and weight of -3.57 ± 16.08 kg (p<0.001). At six-month follow-up the reduction in HbA1c of -3.44 ± 1.29% (p<0.001) and weight of -8.43 ± 16.47 kg (p<0.001), with no significant change in self-reported incidence of hypoglycemia. Conclusions: This retrospective observational study demonstrated that GLP-1 RA naïve adults with T2D initiating semaglutide in a real-world clinical practice had a statistically and clinically significant reduction in HbA1c and body weight after three to six months, with no significant change in reported incidence of adverse events.

Process- and Outcome-Based Financial Incentives to Improve Self-Management and Glycemic Control in People with Type 2 Diabetes in Singapore: A Randomized Controlled Trial.

BackgroundSub-optimally controlled diabetes increases risks for adverse and costly complications. Self-management including glucose monitoring, medication adherence, and exercise are key for optimal glycemic control, yet, poor self-management remains common.ObjectiveThe main objective of the Trial to Incentivize Adherence for Diabetes (TRIAD) study was to determine the effectiveness of financial incentives in improving glycemic control among type 2 diabetes patients in Singapore, and to test whether process-based incentives tied to glucose monitoring, medication adherence, and physical activity are more effective than outcome-based incentives tied to achieving normal glucose readings.MethodsTRIAD is a randomized, controlled, multi-center superiority trial. A total of 240 participants who had at least one recent glycated hemoglobin (HbA1c) being 8.0% or more and on oral diabetes medication were recruited from two polyclinics. They were block-randomized (blocking factor: current vs. new glucometer users) into the usual care plus (UC +) arm, process-based incentive arm, and outcome-based incentive arm in a 2:3:3 ratio. The primary outcome was the mean change in HbA1c at month 6 and was linearly regressed on binary variables indicating the intervention arms, baseline HbA1c levels, a binary variable indicating titration change, and other baseline characteristics.ResultsOur findings show that the combined incentive arms trended toward better HbA1c than UC + , but the difference is estimated with great uncertainty (difference − 0.31; 95% confidence interval [CI] − 0.67 to 0.06). Lending credibility to this result, the proportion of participants who reduced their HbA1c is higher in the combined incentive arms relative to UC + (0.18; 95% CI 0.04, 0.31). We found a small improvement in process- relative to outcome-based incentives, but this was again estimated with great uncertainty (difference − 0.05; 95% CI − 0.42 to 0.31). Consistent with this improvement, process-based incentives were more effective at improving weekly medication adherent days (0.64; 95% CI − 0.04 to 1.32), weekly physically active days (1.37; 95% CI 0.60–2.13), and quality of life (0.04; 95% CI 0.0–0.07) than outcome-based incentives.ConclusionThis study suggests that both incentive types may be part of a successful self-management strategy. Process-based incentives can improve adherence to intermediary outcomes, while outcome-based incentives focus on glycemic control and are simpler to administer.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40271-020-00491-y.

Improved long-term outcomes in high-risk patients receiving registered dietitian nutritionist care

AimsRegistered dietitian nutritionists have been shown to improve weight and HbA1c in high-risk patients, yet little is known about these outcomes long term. MethodsElectronic medical records were reviewed for participants 18 years or older with BMI≥35 kg/m2 or HbA1c≥7.0% at first visit to a patient-centered medical home in Boston, Massachusetts. 1,902 patients met BMI criteria, and 1,240 met HbA1c criteria. Mean change in weight (kg) and HbA1c (%) at six, 12, and 24 months were compared between patients who saw an RDN and patients who received primary care alone. Paired sample t-tests and repeated measures ANOVA adjusting for age, sex, gender, days from baseline at follow-up, and number of visits at follow-up were used to analyze outcomes. ResultsMean weight loss was greater in the RDN group at all time points. HbA1c decreased significantly with RDN care at all time points (P<0.001). Patients with at least one RDN visit had significantly greater mean change in HbA1c of -0.8 ±0.2 (95% CI -1.0 to -0.5) and -0.6 ±0.1 (95% CI -0.8 to -0.3) after 12 and 24 months from baseline, respectively (P<0.001). ConclusionsRDN care resulted in statistically and clinically significant improvements in HbA1c at 12 and 24 months compared to primary care and in significant weight loss up to 24 months.

Dapagliflozin in the management of type 2 diabetes mellitus: a real-life experience in Bangladesh

Background: Dapagliflozin, a selective renal sodium-glucose cotransporter-2 inhibitor (SGLT2i), lowers plasma glucose by increasing urinary excretion of glucose. This study evaluated the efficacy and safety of dapagliflozin as add on therapy for a selected group of Bangladeshi type 2 diabetic patients.&#x0D; Methods: This was a 24-week, open-label, prospective, real-life study including type 2 diabetic patients with glycated hemoglobin (HbA1c) 7.0–10% (N =53). Study subjects were selectively assigned to dapagliflozin 5 mg once-daily in the morning along with ongoing oral anti-diabetic drug (OAD). The primary end point was to see the safety (adverse events) and efficacy (reduction of fasting and post-prandial blood glucose, HbA1c) of dapagliflozin.&#x0D; Results: Mean HbA1c changes from baseline to week 24 was – 1.15 ± 0.82 % (P = 0.000) and weight reduction was – 2.49 ± 0.32 kg from base line (P=0.000). Among total study subjects, 6 (11.3 %) had developed urinary tract infection (UTI). There were no major episodes of hypoglycemia or renal function deterioration.&#x0D; Conclusion: Dapagliflozin showed significant reduction of HbA1c as add on therapy. The low incidence of hypoglycemia and UTI make dapagliflozin as an acceptable addition to existing treatment option for type 2 diabetes in Bangladeshi population.&#x0D; Birdem Med J 2021; 11(1): 57-62

Effectiveness of dietetic intervention for people with type 2 diabetes: A meta-analysis

Diet is central to treatment of type 2 diabetes. This review aimed to compare the effectiveness of nutrition therapy delivered by dietitians to nutrition advice delivered by other healthcare professionals in adults with type 2 diabetes on metabolic parameters. Cochrane CENTRAL, CINAHL, EMBASE, MEDLINE and PsychINFO were searched for randomised controlled trials of three months duration or longer, published from 1st January 2008 to 18th June 2019. Relevant data were extracted from studies with additional author information. Random-effects meta-analysis assessed mean changes in HbA1c and other clinical parameters. PROSPERO registration number: CRD42019130528. Of 2477 records identified, fourteen studies, involving 3338 participants, were eligible for qualitative synthesis and meta-analysis. The mean changes [95% CI] at follow-up in HbA1c, BMI, weight, LDL cholesterol, systolic and diastolic blood pressure were-0·47 [-0·92,-0·02] %,-0·38 [-0·63,-0·13] kg/m2, -1·49 [-2·14,-0·84] kg,-0·15 [-0·33, 0·04] mmol/L,-0·75 [-2·45, 0·96] mm Hg and-1·17 [-4·52, 2·17] mm Hg respectively in favour of the intervention group. The quality of evidence was limited due to heterogeneity, risk of bias, publication bias and indirectness. Nutrition therapy provided by dietitians was associated with better clinical parameters of type 2 diabetes, including clinically significant improved glycaemic control, across diverse multiethnic patient groups from all six inhabited continents. This conclusion should be reflected in clinical guidelines.

Long-term efficacy and safety of oral semaglutide and the effect of switching from sitagliptin to oral semaglutide in patients with type 2 diabetes: a 52-week, randomized, open-label extension of the PIONEER 7 trial

IntroductionThe PIONEER 7 trial demonstrated superior glycemic control and weight loss with once-daily oral semaglutide with flexible dose adjustment versus sitagliptin 100 mg in type 2 diabetes. This 52-week extension...

Meta-Analysis of 11 Heterogeneous Studies regarding Dipeptidyl Peptidase 4 Inhibitor Add-On Therapy for Type 2 Diabetes Mellitus Patients Treated with Insulin.

Background Several clinical trials have addressed the therapeutic strategy of adding dipeptidyl peptidase 4 (DPP-4) inhibitors to the treatment of type 2 diabetes mellitus (DM) inadequately controlled by insulin therapy. However, there is a high degree of heterogeneity in these studies, and the cause of which has not been identified. Methods We conducted a meta-analysis of randomized controlled trials, which compared the efficacy and safety of adding DPP-4 inhibitors or placebo to insulin therapy; the level of hemoglobin A1c (HbA1c) in the patients was >7.0%, and the duration of treatment was ≥8 weeks. We focused on the mean changes in HbA1c from the baseline (ΔHbA1c) and the incidence of hypoglycemia. We assumed that five baseline parameters (HbA1c, fasting blood glucose, body mass index (BMI), duration of type 2 DM, and duration of treatment) could affect ΔHbA1c. Regarding the incidence of hypoglycemia, we suspected that the heterogeneity was caused by differences in the definition of hypoglycemia among the studies. Results Data obtained from 11 studies (n = 4654 patients) were included in the analysis. The mean ΔHbA1c between the DPP-4 inhibitor and placebo groups was -0.61% (95% confidence interval (CI): -0.74 to -0.48, I2 = 73.4%). There was substantial heterogeneity among the 11 studies, but 74.1% of this variability was explained by the difference in BMI. The odds ratio for the incidence of hypoglycemia was 1.02 (95% CI: 0.74 to 1.42, I2 = 63.8%), with substantial heterogeneity due to differences in the definition of hypoglycemia among the studies. There was no apparent effect of publication bias. Conclusions The addition of DPP-4 inhibitors to insulin therapy for adult patients with type 2 DM can significantly reduce HbA1c levels without increasing the occurrence of hypoglycemia. BMI and hypoglycemia definition could explain the heterogeneity in the clinical trials. This trial is registered with PROSPERO #CRD42016035994.

Efficacy, safety and cost-effectiveness comparison between U-100 human regular insulin and rapid acting insulin when delivered by V-Go wearable insulin delivery device in type 2 diabetes

IntroductionWe compared the efficacy and safety of human regular insulin (HRI) versus rapid-acting insulin (RAI) in a type 2 diabetes population already using the V-Go insulin delivery device.Research design and...

Quantitative evaluation of an outreach case management model of care for urban Aboriginal and Torres Strait Islander adults living with complex chronic disease: a longitudinal study

BackgroundChronic diseases are the leading contributor to the excess morbidity and mortality burden experienced by Aboriginal and Torres Strait Islander (hereafter, respectfully, Indigenous) people, compared to their non-Indigenous counterparts. The Home-based Outreach case Management of chronic disease Exploratory (HOME) Study provided person-centred, multidisciplinary care for Indigenous people with chronic disease. This model of care, aligned to Indigenous peoples’ conceptions of health and wellbeing, was integrated within an urban Indigenous primary health care service. We aimed to determine the impact of this model of care on participants’ health and wellbeing at 12 months.MethodsHOME Study participants were Indigenous, regular patients of the primary health care service, with a diagnosis of at least one chronic disease, and complex health and social care needs. Data were collected directly from participants and from their medical records at baseline, and 3, 6 and 12 months thereafter. Variables included self-rated health status, depression, utilisation of health services, and key clinical outcomes. Participants’ baseline characteristics were described using frequencies and percentages. Generalized estimating equation (GEE) models were employed to evaluate participant attrition and changes in outcome measures over time.Results60 participants were enrolled into the study and 37 (62%) completed the 12-month assessment. After receiving outreach case management for 12 months, 73% of participants had good, very good or excellent self-rated health status compared with 33% at baseline (p < 0.001) and 19% of participants had depression compared with 44% at baseline (p = 0.03). Significant increases in appointments with allied health professionals (p < 0.001) and medical specialists other than general practitioners (p = 0.001) were observed at 12-months compared with baseline rates. Mean systolic blood pressure decreased over time (p = 0.02), but there were no significant changes in mean HbA1c, body mass index, or diastolic blood pressure.ConclusionsThe HOME Study model of care was predicated on a holistic conception of health and aimed to address participants’ health and social care needs. The positive changes in self-rated health and rates of depression evinced that this aim was met, and that participants received the necessary care to support and improve their health and wellbeing.

Effectiveness of Dietetic Intervention for People with Type 2 Diabetes: A Meta-Analysis

Background: Diet is central to treatment of type 2 diabetes. It is unclear if nutrition therapy provided by accredited dietitians achieves different outcomes to nutrition advice by other healthcare professionals. We compared the effectiveness of nutrition therapy by dietitians to advice from other healthcare professionals in adults with type 2 diabetes on clinical parameters. Methods: We conducted a systematic review and meta-analysis of type 2 diabetes management programmes implementing nutrition therapy. We searched Cochrane CENTRAL, CINAHL, EMBASE, MEDLINE and PsychINFO for randomised controlled trials in adults, of three months duration or longer, published from 1st January 2008 to 18th June 2019. Relevant data were extracted from studies with additional author information. Random-effects meta-analysis assessed mean changes in HbA1c and other clinical parameters. PROSPERO registration number: CRD42019130528. Findings: Of 2477 records identified, fourteen studies (n = 3338) were eligible for qualitative synthesis and meta-analysis. The mean changes [95% CI] at follow-up in HbA1c, BMI, weight, LDL cholesterol, systolic and diastolic blood pressure were -0·47 [-0·92, -0·02] %, -0·38 [-0·63, -0·13] kg/m2, -1·49 [-2·14, -0·84] kg, -0·15 [-0·33, 0·04] mmol/L, -0·75 [-2·45, 0·96] mm Hg and -1·17 [-4·52, 2·17] mm Hg respectively in favour of the intervention group. Heterogeneity was considerable as expected when combining data from a range of healthcare systems. Interpretation: Nutrition therapy provided by dietitians was associated with better clinical parameters of type 2 diabetes, including clinically significant improved glycaemic control, across diverse multiethnic patient groups from all six inhabited continents. This conclusion should be reflected in clinical guidelines. Funding Statement: None. Declaration of Interests: The authors declare no competing interests.

A Multicentre, Multinational, Open-Label, 52-Week Extension Study of Gemigliptin (LC15-0444) Monotherapy in Patients with Type 2 Diabetes Mellitus

The purpose of this extension study was to assess the long-term efficacy and safety of gemigliptin 50 mg in patients with type 2 diabetes mellitus (T2DM). Patients with T2DM who had completed the initial 24-week study comparing gemigliptin monotherapy with placebo were eligible to enrol. In the open-label, 28-week extension study, all enrolled patients received gemigliptin, regardless of the treatment received during the initial 24-week study period. The mean reduction±standard deviation (SD) in glycosylated hemoglobin (HbA1c) observed after 24 weeks of treatment (–0.6%±1.1%) was further decreased for the gemi-gemi group and the mean change in HbA1c at week 52 from baseline was –0.9%±1.2% (P<0.0001). For the pbo-gemi group, HbA1c decreased after they were switched to gemigliptin, and the mean change in HbA1c at week 52 from baseline was –0.7%±1.2% (P<0.0001). Furthermore, the overall incidence of adverse events demonstrated that gemigliptin was safe and well tolerated up to 52 weeks.

Impact of Physician-Pharmacist Collaboration on Diabetes Outcomes and Health Care Use.

To evaluate the impact of physician-pharmacist collaboration for disease-state management on diabetes outcomes in primary care by comparing outcomes between physician-managed care and pharmacist collaborative care. A retrospective, observational cohort study was conducted at Ascension Medical Group Via Christi, P.A. from January 1, 2016 to June 30, 2018. Health outcomes were analyzed in 385 patients with diabetes mellitus collaboratively managed by a physician and pharmacist (collaborative care group). Similar patients managed by physician only (usual care group) were matched to the collaborative care group using nearest neighbor matching. The primary outcome compared glycosylated hemoglobin (HbA1c) change between collaborative care and usual care groups at 12 months. The mean change in HbA1c decreased by 1.75% in the collaborative care group and 0.16% in the usual care group (P < .0001). The usual care group had a larger number of patients with HbA1c less than 8% at follow-up (P = .0049). Additional outcomes included decrease in total cholesterol (P = .0023), triglycerides (P = .0016), and an increase in PPSV23 pneumococcal vaccinations (P = .0255) in the collaborative care group. The usual care group had an increase in PCV13 pneumococcal vaccinations (P = .0075). Both emergency department visits (P = .0162) and hospitalizations (P = .0225) decreased significantly in the collaborative care group, estimating total savings of $633,015. The collaboration of pharmacists and physicians in the primary care setting is associated with improved diabetes outcomes and substantially reduces costs related to decreased health care use.

The Smart Life Stay (SLS) program: effects of a lifestyle intervention program in combination with health tourism and health guidance for type 2 diabetes

BackgroundThe aim of this study was to determine the effectiveness of the Smart Life Stay (SLS) program, which is an experience-oriented stayover program, in combination with health tourism and mandatory health guidance on glucose metabolism after 2 years.MethodsThe participants of the SLS program (n = 792) were recruited from a database of 23 medical insurers. They underwent a mandatory health examination termed Specific Health Checkups in 2014. The participants were included if they had diabetes or were at a high risk of diabetes and if they satisfied the following inclusion criteria: (1) body mass index (BMI; kg/m2) > 25, or (2) waist circumference (WC; cm) > 85 for men and > 90 for women, or (3) hemoglobin A1c (HbA1c; %) > 5.6, or (4) fasting plasma glucose (FPG; mg/dl) > 100. Individuals who corresponded to one or more items were included as study participants. The control subjects (n = 3645) were nonparticipants of the program who were selected from the database and met the inclusion criteria. The lifestyle changes and changes in mean BMI, WC, FPG, and HbA1c in both groups from baseline to 2-year follow-up were compared by inverse probability weighting of a propensity score.ResultsThe percentage of people who exercised regularly increased significantly in the SLS group compared with the control group. In the SLS group, BW, BMI, and WC significantly decreased by 1.75 kg, 0.60 kg/m2, and 1.45 cm, respectively, whereas in the control group, WC, FPG, and HbA1c increased significantly by 0.38 cm, 3.37 mg/dl, and 0.12%, respectively. The comparison between groups revealed that the BW, BMI, WC, FPG, and HbA1c improved significantly in the SLS group.ConclusionsThe SLS program is suggested to help improve glucose metabolism. This program could be a feasible option as a lifestyle intervention program for diabetes.

Effect of dairy consumption and its fat content on glycemic control and cardiovascular disease risk factors in patients with type 2 diabetes: a randomized controlled study

Dietary Guidelines for Americans recommend the consumption of 3 servings/d of low-fat/nonfat dairy. The effects of higher dairy consumption and its fat content are unknown in patients with type 2 diabetes. Evaluate the impact of higher consumption of high- compared with low-fat dairy on glycated hemoglobin (HbA1c), body weight, and cardiovascular disease risk factors in patients with type 2 diabetes. We enrolled 111 subjects with type 2 diabetes (aged 58.5±8.9 y, 47% females, diabetes duration 13.2±8.3 y, HbA1c 8.09±0.96%) who consumed<3 servings of dairy/d. We randomly assigned them into 3 groups: control group maintained baseline dairy intake, low-fat (LF) group incorporated≥3 servings/d of LF dairy, and the high-fat (HF) group incorporated≥3 servings/d of HF dairy. We evaluated HbA1c, body weight, BMI, body composition parameters, blood pressure (BP), lipid parameters, homeostatic model assessment of insulin resistance (HOMA-IR), and total energy and macronutrient intake at baseline, and after 12 and 24 wk. At 24 wk, percent energy from saturated fat increased from baseline in the HF group by 3.6%, (95% CI: 2.2, 5.1) and decreased in the LF groupby -1.9% (95% CI: -3.3, -0.4). The LF group increased their percent energy from protein by 4.5% (95% CI: 2.6, 6.4), whereas the HF group decreased their percent energy from carbohydrates by-3.4% (95% CI: -0.2, -6.7). There were no differences in the mean changes in HbA1c, body weight, BMI, body composition or lipid parameters, or BP between the 3 groups at 24 wk. In patients with type 2 diabetes, increased dairy consumption to≥3 servings/d compared with<3 servings/d, irrespective of its fat content, while maintaining energy intake has no effect on HbA1c, body weight, body composition, lipid profile, or BP. This trial was registered at clinicaltrials.gov as NCT02895867.

Sotagliflozin added to optimized insulin therapy leads to HbA1c reduction without weight gain in adults with type 1 diabetes: A pooled analysis of inTandem1 and inTandem2.

To evaluate whether the addition of sotagliflozin to optimized insulin significantly increases the proportion of adults with type 1 diabetes who achieve HbA1c goals without weight gain. In a patient-level pooled analysis (n = 1575) of data from two phase 3, 52-week clinical trials (inTandem1 and inTandem2), the change from baseline in HbA1c and weight as well as the proportion of participants achieving an HbA1c of less than 7% without weight gain were compared between groups treated with placebo, sotagliflozin 200 mg and sotagliflozin 400 mg. From a mean baseline HbA1c of 7.7%, mean HbA1c changes at week 24 were -0.36% (95% CI -0.44% to -0.29%) and -0.38% (-0.45% to -0.31%) with sotagliflozin 200 and 400 mg versus placebo (P = .001 for both), respectively, with sustained effects through week 52. Weight significantly decreased at weeks 24 and 52 in both sotagliflozin groups compared with placebo. At week 52, the proportion of patients who achieved an HbA1c of less than 7% without weight gain was 21.8% with sotagliflozin 200 mg, 26.1% with sotagliflozin 400 mg and 9.1% with placebo (P < .001). Other HbA1c, weight and safety composite variables showed similar significant trends. When added to optimized insulin therapy, sotagliflozin improved glycaemic control and body weight and enabled more adults with type 1 diabetes to achieve HbA1c goals without weight gain over 52 weeks, although there was more diabetic ketoacidosis relative to placebo.

Real-World Clinical Outcomes Associated with Canagliflozin in Patients with Type 2 Diabetes Mellitus in Spain: The Real-Wecan Study.

The aims of this multicentric retrospective study were to assess in a real-world setting the effectiveness and safety of canagliflozin 100 mg/d (CANA100) as an add-on to the background antihyperglycemic therapy, and to evaluate the intensification of prior sodium–glucose co-transporter type 2 inhibitor (SGLT-2i) therapy by switching to canagliflozin 300 mg/d (CANA300) in patients with T2DM. One cohort of SGLT2i-naïve patients with T2DM who were initiated on CANA100 and a second cohort of patients with prior background SGLT-2i therapy who switched to CANA300 were included in the study. The primary outcome of the study was the mean change in HbA1c over the follow-up time. In total, 583 patients were included—279 in the cohort of CANA100 (HbA1c 8.05%, weight 94.9 kg) and 304 in the cohort of CANA300 (HbA1c 7.51%, weight 92.0 kg). Median follow-up periods in both cohorts were 9.1 and 15.4 months respectively. CANA100 was associated to significant reductions in HbA1c (−0.90%) and weight (−4.1 kg) at the end of the follow-up. In those patients with baseline HbA1c > 8% (mean 9.25%), CANA100 lowered HbA1c levels by 1.51%. In the second cohort, patients switching to CANA300 experienced a significant decrease in HbA1c (−0.35%) and weight (−2.1 kg). In those patients with baseline HbA1c > 8% (mean 8.94%), CANA300 lowered HbA1c levels by 1.12%. There were significant improvements in blood pressure in both cohorts. No unexpected adverse events were reported. In summary, CANA100 (as an add-on therapy) and CANA300 (switching from prior SGLT-2i therapy) significantly improved several cardiometabolic parameters in patients with T2DM.

Effect of Gliclazide or Gliclazide plus Metformin Combination on Glycemic Control in Patients with T2DM in India: A Real-World, Retrospective, Longitudinal, Observational Study from Electronic Medical Records.

BackgroundThe efficacy of gliclazide has been reported in clinical trials in India. However, real-world data on the effectiveness of gliclazide in India is unavailable.ObjectiveTo provide real-world evidence regarding the effectiveness of gliclazide or gliclazide + metformin fixed-dose combination or separate medications, used either as monotherapy or as the latest add-on to other antihyperglycemic agents in reducing glycated hemoglobin (HbA1c) levels in Indian patients with type 2 diabetes mellitus (T2DM).MethodsElectronic medical record data of adult patients who were diagnosed with T2DM who were newly initiated on or had been prescribed gliclazide or gliclazide + metformin combination for < 30 days as monotherapy or as add-on therapy to other antihyperglycemic agents, and had HbA1c ≥ 6.5% were retrospectively analyzed. Mean change in HbA1c from baseline was the primary endpoint. Secondary endpoints were assessment of dosages and formulations of gliclazide or gliclazide + metformin prescribed in the HbA1c spectrum and antihyperglycemic agents to which gliclazide or gliclazide + metformin was added as an adjunct. Readings were obtained before initiating gliclazide or gliclazide + metformin and after at least 90 days of treatment with gliclazide or gliclazide + metformin.ResultsIncluded patients (n = 498) were categorized into gliclazide only (n = 66), gliclazide + metformin only (n = 179), gliclazide add-on (n = 169), and gliclazide + metformin add-on (n = 84) groups. Mean (95% confidence interval [CI]) change in HbA1c among patients with baseline HbA1c > 7% was − 0.8% (− 1.26, − 0.34) in gliclazide only group; − 1.6% (− 1.89, − 1.31; p < 0.001) in gliclazide + metformin group; − 1.2% (− 1.50, − 0.90; p < 0.001) in add-on gliclazide group; and − 1.4% (− 1.75, − 1.05; p < 0.001) in add-on gliclazide + metformin group. Gliclazide once daily was the most prescribed regimen in the gliclazide only group (72.7%), with 60 mg being the most prescribed modified-release dose (62.5%). Gliclazide + metformin twice daily was the most prescribed regimen in the gliclazide + metformin group (69.3%) with 80 mg + 500 mg being the most prescribed immediate-release dose (62.9%). Gliclazide and gliclazide + metformin were most added as an adjunct to existing prescriptions of biguanides (83.4%) or insulin (64.3%), respectively.ConclusionGliclazide or gliclazide + metformin prescribed as mono- or add-on therapy during routine clinical practice effectively reduced HbA1c in Indian patients with T2DM, thus validating the use of gliclazide and gliclazide + metformin for managing T2DM in India.

Effect of clinical inertia and trial participation in younger and older adults with diabetes having comorbidities and progressive complications

AimClinical inertia is a multifactorial phenomenon, with contributing factors from people with diabetes and their healthcare team. It is widely cited that clinical inertia is minimised by participation in clinical trials. We assessed whether trial participation per se improves metabolic parameters in people with diabetes, or a specific focus on glycaemia is required. MethodsWe compared improvement in glycaemic control in a pooled set of people assigned to the “placebo” arm from 25 glycaemia-focused trials with a pooled group of people with diabetes allocated to sham or non-pharmacological intervention for the treatment of diabetic retinal disease. Mean change in HbA1c (ANCOVA) was evaluated. ResultsThe overall placebo effect in studies focused on glucose control (N = 3081) was comparable between strata groups with and without complications. Adjusted least square mean change in HbA1c at 24 weeks was between −0.23% (−2.50 mmol/mol) and −0.32% (−3.50 mmol/mol). In studies focused on retinal disease (N = 288), the change from baseline in HbA1c was +0.10% (1.10 mmol/mol) and fasting plasma glucose was +0.50 mmol/L showing no improvement in metabolic parameters at 12 months. ConclusionsClinical trial participation alone does not seem to improve metabolic parameters in people living with diabetes. The benefits observed in glycaemia-focused studies were independent of age and comorbidities.

Glycemic Effects Of Exercise In Sri Lankans Adults With Type 2 Diabetes Mellitus

The prevalence of type 2 Diabetes Mellitus (T2DM) is rising in South Asia. Although exercise training is recommended for its management, the effects of exercise training on glycemic control in Sri Lankans with T2DM has not been studied. PURPOSE: To examine the effects of aerobic training (AT) and resistance training (RT) on glycemic control in Sri Lankan adults with T2DM. METHODS: 86 Sedentary Sri Lankans (50.1±8.7 years, 53% women) diagnosed with T2DM within last 6 years were randomized into AT (n=28), RT (n=28) or control (CN, n=30). Supervised exercise training was performed for 75 minutes per session, 2 days/week for 12 weeks. RT targeted 7 (i.e., 3 upper body, 3 lower body, 1 core) exercises. AT included brisk walking, stepping and stationary cycling at an intensity of 60-75% heart rate max. Fasting blood glucose (FBG), HbA1c, and fasting insulin (FI) were measured at baseline and post intervention. RESULTS: Baseline mean BMI, HbA1c, FBG and FI were 26.4 kg/m2±4.0, 8.2±1.7%, 146.9 ±54.1 mg/dl and 13.3±8.5 micIU/ml, respectively. Subject characteristics were similar among groups, except the CN group had higher mean HbA1c level (8.9 ± 1.7%). Absolute mean change in HbA1c was not significant across groups; RT 0.6 % (95% CI; 1.16% to -0.01%, p=0.8), AT 0.74 % (95% CI; 1.25% to -0.24 %, p=0.5) or CN 0.52% (95% CI, 1.1% to 0.03%.p= 0.8). Absolute mean change in FBG significantly improved in RT (−3.8 mg/dl [95% CI, 4.9 to -12.6 mg/dl; p=0.02]) and CN (25.6 mg/dl [95% CI; 48.5 to 3.0 mg/dl, p= 0.04]), but not AT (20.1 mg/dl [95% CI, 39.6 to 0.6 mg/dl, p= 0.5]). Absolute mean change in FI did not significantly increase in RT (0.2 micIU/ml [95% CI, (2.9 to -2.4 micIU/ml, p = 0.1]) or AT (0.2 micIU/ml [95% CI; 2.9 to -2.5 micIU/ml, p = 0.1]) but did in the CN group (3.0 micIU/ml [95% CI, 0.8 to -8.3 micIU/ml, p=0.00]). CONCLUSION: To our knowledge this is the first randomized controlled trial to study the effects of AT and RT on glycemic control in Sri Lankan diabetics. Intervention showed mixed effects in improvement in chronic glycemic control (HbA1c) and in short term glycemic control (FBG). FI did not increase in intervention groups which demonstrated reduced disease progression. Future studies with larger sample sizes are need for definitive conclusions.