scholarly journals Real-World Clinical Experience on the Usage of High-Dose Metformin (1500-2500 mg/day) in Type 2 Diabetes Management

2021 ◽  
Vol 14 ◽  
pp. 117955142110305
Author(s):  
Ashok Kumar Das ◽  
Sanjiv Shah ◽  
Santosh Kumar Singh ◽  
Archana Juneja ◽  
Niroj Kumar Mishra ◽  
...  

Background: To evaluate the clinical characteristics, treatment patterns, and clinical effectiveness and safety of high doses of metformin (1500-2500 mg/day) in Indian adults with type 2 diabetes mellitus (T2DM). Materials and methods: A retrospective, multicentric (n = 241), real-world study included patients with T2DM (aged >18 years) receiving high doses of metformin. Details were retrieved from patient’s medical records. Results: Out of 5695 patients, 62.7% were men with median age was 50.0 years. Hypertension (67.5%) and dyslipidemia (48.7%) were the prevalent comorbidities. Doses of 2000 mg (57.4%) and 1500 mg (29.1%) were the most commonly used doses of metformin and median duration of high-dose metformin therapy was 24.0 months. Metformin twice daily was the most frequently used dosage pattern (94.2%). Up-titration of doses was done in 96.8% of patients. The mean HbA1c levels were significantly decreased post-treatment (mean change: 1.08%; P < .001). The target glycemic control was achieved in 91.2% patients. A total of 83.0% had decreased weight. Adverse events were reported in 156 patients. Physician global evaluation of efficacy and tolerability showed majority of patients on a good to excellent scale (98.2% and 97.7%). Conclusion: Clinical effectiveness and safety of a high-dose metformin was demonstrated through significant improvement in HbA1c levels and weight reduction.

2021 ◽  
Vol 17 (3) ◽  
pp. 413-423
Author(s):  
Sambit Das ◽  

It is of interest to evaluate the clinical effectiveness and safety of vildagliptin as monotherapy and combination therapy of vildagliptin and metformin for the management of type 2 diabetes mellitus (T2DM) patients in Indian settings. The study included patients with T2DM (aged >18 years) receiving vildagliptin monotherapy and vildagliptin in combination with metformin therapy of various strengths. Data related to demographics, risk factors, medical history, glycated hemoglobin (HbA1c) levels, and medical therapies were retrieved from medical records. Out of 9678 patients (median age, 52.0 years), 59.1% were men. A combination of vildagliptin and metformin (50/500 mg) was the most commonly used therapy (54.8%), and the median duration of therapy was 24.0 months. The predominant reason for selecting vildagliptin therapy was to improve HbA1c levels (87.8%). A total of 87.5% of patients required dosage up-titration. Vildagliptin therapy was used in patients with T2DM and associated complications (peripheral neuropathy, CAD, nephropathy, retinopathy, autonomous neuropathy, stroke/TIA, and peripheral artery disease). Among 5175 patients who experienced body weight changes, a majority of patients had lost weight (68.6%). The target glycemic control was achieved in 95.3% of patients. The mean HbA1c levels were significantly decreased post-treatment (mean change: 1.34%; p<0.001). Adverse events were reported in 0.4% of patients. Physicians rated the majority of patients as good to excellent on the global evaluation of efficacy and tolerability scale (98.9%, each). Vildagliptin with or without metformin was an effective therapy in reducing HbA1c helps in achieving target glycemic control, and was well-tolerated in Indian patients with T2DM continuum.


2020 ◽  
Vol 9 (7) ◽  
pp. 2275
Author(s):  
Juan J. Gorgojo-Martínez ◽  
Manuel A. Gargallo-Fernández ◽  
Alba Galdón Sanz-Pastor ◽  
Teresa Antón-Bravo ◽  
Miguel Brito-Sanfiel ◽  
...  

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.


2005 ◽  
Vol 31 (6) ◽  
pp. 843-848 ◽  
Author(s):  
Susan Nielsen ◽  
Donna Kain ◽  
Elizabeth Szudzik ◽  
Sandeep Dhindsa ◽  
Rajesh Garg ◽  
...  

Purpose In patients with type 2 diabetes, the control of hyperglycemia is often difficult despite full doses of oral hypoglycemic agents and extremely large doses of insulin. These patients pose a major management problem. The authors therefore investigated whether insulin given as a subcutaneous continuous infusion of insulin (CSII) would result in an improvement in glucose homeostasis. Methods Four patients with badly controlled type 2 diabetes, on treatment with extremely high doses of insulin and oral hypoglycemic agents, were started on CSII. Results All four patients had a marked improvement in plasma glucose concentrations with a corresponding fall in HbA1c levels. This improvement was associated with a marked fall in the insulin doses necessary to maintain adequate glucose homeostasis. Conclusions Since HbA1c levels fell from levels that would be associated with diabetic complications to those at which complications are markedly reduced, we recommend that patients with type 2 diabetes uncontrolled on extremely high doses of insulin be given a trial of treatment with CSII.


2020 ◽  
Author(s):  
Masumeh Hemmati Maslakpak ◽  
Naser Parizad ◽  
Amir Ghahremani ◽  
Vahid Alinejad

Abstract Background Self-efficacy predicts adherence to treatment in patients with diabetes. Motivational interviewing could be a promising intervention to increase the patients’ motivation to follow therapeutic recommendations. The present study aimed to assess the effects of motivational interviewing on self-efficacy in type 2 diabetes management. Methods This quasi-experimental study with a pretest-posttest design was conducted on 60 patients with type 2 diabetes, who were members of the Bukan Diabetes Association in Iran. The patients were selected using a random number table and were randomly allocated into intervention (n = 30) and control (n = 30) groups. Five motivational interviewing sessions (30–45 minutes) were held for the intervention group (two sessions per week). Data were collected using a demographic questionnaire and the diabetes management self-efficacy scale (DMSES). Data were analyzed with SPSS software version 14.0 using descriptive and inferential statistics. Results Sixty patients entered the analysis. A significant difference was observed in the mean score of diabetes management self-efficacy between the two groups before and after the intervention (P = 0.014). The mean score of self-efficacy in diabetes management was increased significantly in the intervention group after MI (P = 0.001). Conclusions Motivational interviewing improved self-efficacy in diabetes management. Thus, this approach is recommended to be used in patients with type 2 diabetes in order to increase their self-efficacy.


Iproceedings ◽  
10.2196/16298 ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e16298
Author(s):  
Connor Devoe ◽  
Nils Fischer ◽  
Tim Hale ◽  
Neda Derakhshani ◽  
Mursal Atif ◽  
...  

Background Type 2 diabetes (T2D) is the seventh leading cause of death (2017) in the United States, and by 2030 it is estimated that it will affect 439 million globally. Effective glycemic control can be challenging for patients. A tool to guide patients’ in their self-management behaviors and share this data with their physician may improve insulin adherence leading to lower HbA1c. We examined an integrated diabetes management (IDM) system that utilizes a Bluetooth-enabled insulin event capture device, a Bluetooth-enabled glucometer, and an Android smartphone app. IDM data can be viewed by clinicians in the electronic medical record (EMR). Objective The primary aim of this study is to describe how app use is related to insulin adherence, blood glucose measurements, meal snapshots, and step count. Secondarily, we assessed the impact on HbA1c levels over a 3- and 6-month period. Methods Thirty-five participants were enrolled from Boston-area hospitals in this single-arm pilot study. Use of the IDM system was defined as the number of days per week participants logged into the app and moved past the home screen. Three app use groups were created: low app use (0.33-2.46 days per week), medium app use (2.54-5.08 days per week), and high app use (>5.4 days per week). Adherence to insulin, blood glucose measurements, and meal snapshots were defined as a ratio of actual weekly events recorded by participants’ app use divided by their physician’s recommendation. Step count was defined as the total weekly steps for each participant. Daily app-generated data on app use and indicators of diabetes management were collected. HbA1c levels were assessed via blood test at enrollment, 3-months, and 6-months. Using a hierarchical linear mixed model, we examined changes in outcome measures while accounting for random intercepts and slopes to control for variation in individual outcomes over the study. Results Overall app use (average unique days using the app per week) declined from 6.19 days to 3.00 days (at 1 and 24 weeks, respectively). Participants with high app use had significant improvement in bolus and basal insulin adherence per week (0.009 P=.041 [95% CI 0.0004 to 0.018] and 0.016 P<.001 [95% CI 0.0079 to 0.023], respectively), but participants had no significant improvements in blood glucose and meal snapshot adherence or absolute step count. HbA1c significantly decreased per week (coefficient –0.025 [95% CI –0.044 to –0.007], P=.007) with an overall change of 0.6. Participants with high app use significantly improved their HbA1c per week (–0.037 P=.016 [–0.066 to –0.0067]) compared to participants with medium and low app use, yielding a total improvement of 0.88 over 24 weeks. Conclusions Results show that bolus and basal insulin may have increased with higher app use. HbA1c significantly improved over the course of the study, along with significantly greater improvement in HbA1c among participants with higher app use compared to participants in the middle or low app use groups. This study is not designed or intended to evaluate efficacy but provides results to guide the future design and development of this prototype IDM system.


2018 ◽  
Vol 22 (26) ◽  
pp. 1-328 ◽  
Author(s):  
Allan House ◽  
Louise Bryant ◽  
Amy M Russell ◽  
Alexandra Wright-Hughes ◽  
Liz Graham ◽  
...  

BackgroundObesity and type 2 diabetes are common in adults with a learning disability. It is not known if the principles of self-management can be applied in this population.ObjectivesTo develop and evaluate a case-finding method and undertake an observational study of adults with a learning disability and type 2 diabetes, to develop a standardised supported self-management (SSM) intervention and measure of adherence and to undertake a feasibility randomised controlled trial (RCT) of SSM versus treatment as usual (TAU).DesignObservational study and an individually randomised feasibility RCT.SettingThree cities in West Yorkshire, UK.ParticipantsIn the observational study: adults aged > 18 years with a mild or moderate learning disability, who have type 2 diabetes that is not being treated with insulin and who are living in the community. Participants had mental capacity to consent to research and to the intervention. In the RCT participants had glycated haemoglobin (HbA1c) levels of > 6.5% (48 mmol/mol), a body mass index (BMI) of > 25 kg/m2or self-reported physical activity below national guideline levels.InterventionsStandardised SSM. TAU supported by an easy-read booklet.Main outcome measures(1) The number of eligible participants identified and sources of referral; (2) current living and support arrangements; (3) current health state, including level of HbA1c, BMI and waist circumference, blood pressure and lipids; (4) mood, preferences for change; (5) recruitment and retention in RCT; (6) implementation and adherence to the intervention; (7) completeness of data collection and values for candidate primary outcomes; and (8) qualitative data on participant experience of the research process and intervention.ResultsIn the observational study we identified 147 eligible consenting participants. The mean age was 54.4 years. In total, 130 out of 147 (88%) named a key supporter, with 113 supporters (77%) being involved in diabetes management. The mean HbA1clevel was 54.5 mmol/mol [standard deviation (SD) 14.8 mmol/mol; 7.1%, SD 1.4%]. The BMI of 65% of participants was > 30 kg/m2and of 21% was > 40 kg/m2. Many participants reported low mood, dissatisfaction with lifestyle and diabetes management and an interest in change. Non-response rates were high (45/147, 31%) for medical data requested from the primary care team. In the RCT, 82 participants were randomised. The mean baseline HbA1clevel was 56 mmol/mol (SD 16.5 mmol/mol; 7.3%, SD 1.5%) and the mean BMI was 34 kg/m2(SD 7.6 kg/m2). All SSM sessions were completed by 35 out of 41 participants. The adherence measure was obtained in 37 out of 41 participants. The follow-up HbA1clevel and BMI was obtained for 75 out of 82 (91%) and 77 out of 82 (94%) participants, respectively. Most participants reported a positive experience of the intervention. A low response rate and difficulty understanding the EuroQol-5 Dimensions were challenges in obtaining data for an economic analysis.LimitationsWe recruited from only 60% of eligible general practices, and 90% of participants were on a general practice learning disability register, which meant that we did not recruit many participants from the wider population with milder learning disability.ConclusionsA definitive RCT is feasible and would need to recruit 194 participants per arm. The main barrier is the resource-intensive nature of recruitment. Future research is needed into the effectiveness of obesity treatments in this population, particularly estimating the longer-term outcomes that are important for health benefit. Research is also needed into improving ways of assessing quality of life in adults with a learning disability.Trial registrationCurrent Controlled Trials ISRCTN41897033.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 26. See the NIHR Journals Library website for further project information.


2020 ◽  
Vol 20 (7) ◽  
pp. 1090-1096
Author(s):  
Yusuf Bozkuş ◽  
Umut Mousa ◽  
Özlem T. İyidir ◽  
Nazlı Kırnap ◽  
Canan Ç. Demir ◽  
...  

Objective: Proton pump inhibitor (PPI) drugs reduce gastric acid secretion and lead to an increase in serum gastrin levels. Many preclinical and some clinical researches have established some positive effects of gastrin or PPI therapy on glucose regulation. The aim of this study was to prospectively investigate the short term effects of esomeprazole on glycaemic control in patients with type 2 diabetes mellitus. In addition, the presence of an association between this effect and gastrin levels was evaluated. Methods: Thirty-two subjects with type 2 diabetes mellitus were enrolled and grouped as intervention (n=16) and control (n=16). The participants in the intervention group were prescribed 40 mg of esomeprazole treatment for three months. At the beginning of the study and at the 3rd month, HbA1c level (%) and gastrin levels (pmol/L) of participants were assessed. Then, the groups were compared in terms of their baseline and 3rd month values. Results: In the intervention group, the mean gastrin level increased significantly from 34.3±14.4 pmol/L to 87.4±43.6 pmol/L (p<0.001). The mean HbA1c level was similar to the pre-treatment level (6.3±0.7% vs. 6.4±0.9%, p=0.441). There were no statistically significant differences in all parameters of the control group. The majority of individuals were on metformin monotherapy (65.6 %). The subgroup analysis of metformin monotherapy revealed that, in intervention group, there was a significant increase in gastrin levels (39.9±12.6 vs. 95.5±52.5, p=0.026), but the HbA1c levels did not change (6.0±0.4 % vs. 5.9±0.6 %, p=0.288); and in control group, gastrin levels did not change (37.5 ± 26.7 vs. 36.1 ±23.3, p=0.367), but there was an increase in HbA1c levels (6.1 ± 0.50 vs. 6.4 ± 0.60, p=0.01). Conclusion: Our study demonstrates that esomeprazole has no extra benefit for the controlled diabetic patient in three months. However, in only the metformin-treated subgroup, esomeprazole may prevent the rise in HbA1c level.


2018 ◽  
Vol 15 (3) ◽  
pp. 236-241
Author(s):  
Guy Fagherazzi ◽  
Clélia Chambraud ◽  
Courtney Dow ◽  
Francesca Romana Mancini ◽  
Aurélie Affret ◽  
...  

Objectives Identification of characteristics associated with a negative experience with type 2 diabetes may help to develop novel intervention to improve the outlook of people with the disease. Our aim was to identify determinants of a self-reported concerned vision about the future when living with type 2 diabetes. Methods In 2630 women with type 2 diabetes from the E3N-AfterDiab study, we used multivariable logistic regression models to derive odds-ratios and 95% confidence intervals. Results Women with elevated HbA1c levels (OR = 2.42 (1.67–3.49) for ≥7.2% when compared to <6.2%), or treated with injected glucose lowering treatments (OR = 1.37 [1.05–1.81]) had a higher risk of a concerned vision of the future. Age and obesity were associated with a decreased risk. Hypertension, duration of diabetes, smoking, fasting glucose levels, and years of education were not associated with a concerned vision of the future. Discussion Our findings highlight the importance of both glycemic control and the type of treatment on the perception of the future when living with type 2 diabetes. Subgroups of patients based on these characteristics may receive a specific attention from healthcare professionals to address potential concerns related with diabetes management or the fear of complications.


Sign in / Sign up

Export Citation Format

Share Document