Gravicentric approach to Type 2 Diabetes therapy. 
The success prediction. A proof-of-concept

This study is the proof-of-concept of our "Gravicentric" theory. This concept is based on several fundamental points: obesity as the main foe; rapid reversibility of the disease; as well as a new perspective on the roles different pharmacological classes play in general, and the role of insulin and GLP-1 analogs, in particular. The paper presents and discusses our experience of the implementation of insulin and GLP-1 analogs. The possibility of "insulin weaning"; the therapeutic approach for over-treated patients; and physiological dosing of insulin is also discussed therein. Objectives Primary: To evaluate the long-term efficacy of GLP-1 analogs in insulin-treated Type 2 Diabetes Mellitus (T2DM) patients. Secondary: To analyze which patient would most likely benefit from this combined treatment. Methods In 54 T2DM patients with a mean disease duration of 17.5 years and a mean extent of insulin therapy of 4.5 years, additional GLP-1 analogs therapy was prescribed. Mean duration of GLP-1 treatment was 25.8 months (2.15 years). During the intervention, clinical, biochemical, and anthropometric parameters were analyzed. Compliance, Hypoglycemia and Metabolic Index (MI) assessments were implemented. Results Mean Glycated hemoglobin (HbA1C) decreased from 9.28 1.43 to 8.54 1.4% on GLP-1 analogs, p 0.01. Total Daily dose of Insulin (TDI) showed considerable reduction: 80.6 42.7 U/day before starting GLP-1 vs.41.0 30.7 U/day on GLP-1, p 0.01. These changes were directly linked to weight loss: BMI has dropped from 35.1 4.8 kg/cm2 before, to 32.8 5.0 kg/cm2 on GLP-1 analogs, with patients losing 6.7 kg on average. Moreover, 13 (24%) participants discontinued at least one kind of insulin, while 7 (13%) stopped taking insulin completely, with simultaneous improvement in diabetes control. No clinically significant hypoglycemia was observed. Post-hoc, the participants were categorized according to each patients ability to reduce TDI by more than 20 U/day, and then split into two groups. Group A 34 patients (64.2%) who successfully reduced TDI; Group B 19 patients (35.8%) who failed to do so. The comparison of the two groups showed the following: Significantly larger virtually twice as large baseline TDI in Group A (97.440.4 U/day vs. 52.231.0 U/day), p 0.001. Very effective BMI reduction (BMI 3.3 2.4 kg/cm2 0.9 1.2 kg/cm2, p 0.001) and much better compliance (1.4 1.1 vs. 2.2 1.0, p 0.02) in Group A. A considerable decline of insulin requirements in group A, on GLP-1 therapy (TDI on GLP-1 was -62.4 31.9 U/day) with no TDI reduction in Group B (TDI on GLP-1 was +0.03 14.1 U/day, p 0.001). Thus, in spite of the fact that on GLP1 therapy HbA1C has declined to the same levels in both groups, patients from group A became much leaner and metabolically healthier. We suggest overtreatment as the critical factor of obesity in Group A. Conclusions Adding GLP-1 analogs to insulin in poorly controlled, insulin-treated T2DM patients resulted in an impressive weight (BMI) reduction with significant improvements in glucose control. This provided for a further decline in insulin resistance and insulin requirements. We suggest that the best candidate for successful GLP-1 analogs therapy is an obese, overtreated and compliant T2DM person. Changes in Metabolic Index (MI) rather than surrogate glycemic parameters (HbA1C) are better predictors of a successful T2DM therapy. Neither the duration of diabetes nor the length of insulin therapy in the past is likely to have a critical role in predicting success. These findings are proof-of-concept of our Gravicentric theory in T2DM.

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An Efficacy and Safety Study of Remogliflozin in Obese Indian Type 2 Diabetes Mellitus Patients Who Were Inadequately Controlled on Insulin glargine plus other oral hypoglycemic agents

Current Diabetes Reviews ◽

10.2174/1573399817666201222102520 ◽

2020 ◽

Vol 17 ◽

Author(s):

Anand Shankar

Keyword(s):

Type 2 Diabetes ◽

Insulin Glargine ◽

Therapy Group ◽

Insulin Dose ◽

Blood Glucose Control ◽

Hypoglycemic Agents ◽

Oral Drug ◽

Group A ◽

Group B

Aim & Objective: The objective of this retrospective study was to investigate the efficacy of adding remogliflozin to current insulin glargine plus two oral drug i.e. metformin and teneligliptin therapy in poorly controlled Indian type 2 diabetes. Material and Methods: 173 study participants were initially selected from patient database who continued on their insulin glargine or received an increased dose of insulin glargine along with other OHA based therapy (Group A) and 187 were selected who had received remogliflozin (100 mg BD) (Group B) in addition to insulin glargine along with other OHA based therapy. Glycated haemoglobin (HbA1c), total daily insulin dose, body weight, and the number of hypoglycemic events were recorded at weeks 0, 12 and 24. Result: During the study, mean values of HbA1c, FBG and P2BG were significantly reduced in both groups. Insulin requirements decreased from 45.8 ± 16.7 IU/day to 38.5 ± 13.5 IU/day (P < 0.001) and at week 24 even further decreased to 29.5 ± 14.5 IU/Day . Twenty three patients in group B were able to cease insulin treatment altogether after 24 week treatment. It has been observed to attain tight blood glucose control we need to increase insulin dose in group A from 45.5 ± 16.5 IU/Day to 51.5 ± 14.5 at week 12 (P<0.01) and which further increased to 53.8 ± 12.8 IU/Day at week 24 (P<0.01). Adding remogliflozin showed significant effect on blood pressure (P < 0.001) and weight reduction (P < 0.001). It has been observed that 38% patients has achieves targeted HbA1c (≤7%) in group B where it was 22% in group A. Conclusion: Results demonstrate that in uncontrolled T2DM patients remogliflozin 100 mg BD can successfully lay a foundation for prolonged good glycemic control. Early addition of remogliflozin with insulin glargine plus OHAs may be an alternative compare to intensive up titration of insulin daily dose in people with uncontrolled T2DM. Clinical Trial Registration Number: A 2358

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Dipeptidyl peptidase-4 inhibitor (teneligliptin) significantly reduces liver fat content and delays progression of non-alcoholic steatohepatitis in type 2 diabetes mellitus patients

International Journal of Advances in Medicine ◽

10.18203/2349-3933.ijam20214516 ◽

2021 ◽

Vol 8 (12) ◽

pp. 1817

Author(s):

Vishal Kumar Gupta ◽

Richa Giri ◽

Saurabh Agrawal

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Dipeptidyl Peptidase ◽

Liver Fat ◽

Liver Fat Content ◽

Group A ◽

The Mean ◽

Group B

Background: Dipeptidyl peptidase (DPP)-4 inhibitors, anti-diabetic agents, are expected to be effective for treatment of non-alcoholic fatty liver disease (NAFLD). Several studies have shown that some DPP-4 inhibitors alleviate hepatic steatosis or steatohepatitis in type 2 diabetic mice or rats. Teneligliptin is DPP4 inhibitor whose efficacy to control blood sugar is well established but its effect on liver is not studied well. In present study we investigated effect of teneligliptin, a DPP-4 inhibitor on patients of type 2 diabetes with non-alcoholic steatohepatitis (NASH). Methods: This was a randomized, double-blind study in which 64 patients between ages of 18 to 80 years were selected for study. Participants were identified as type 2 diabetes with biopsy confirmed NASH. We excluded the patients with glucocorticoid use, hepatitis B or C, and other diseases that might affect liver function. Results: The mean HbA1c change after 48 weeks of therapy in group A was-1.06 % and in group B was-0.77% and this was statistically insignificant (p>0.06). The mean AST change after 48 weeks of therapy in group A was-45.4% and in group B was-33.3% and this was statistically significant (p<0.001). The mean ALT change after 48 weeks of therapy in group A was-41.6% and in group B was-22.7% and this was statistically significant (p<0.001). The change in liver fat content (LFC) after 48 weeks of therapy in group A was-15.4% and group B was-7.14% and this was also statistically significant (p<0.001).Conclusions: Result of our study revealed that teneligliptin significantly reduce serum transaminases in patients of NASH with type 2 DM. Teneligliptin significantly reduce LFC and delay progression of NASH independent of diabetes control in type 2 diabetes mellitus (DM) patients. These data show significant antisteatotic and anti-inflammatory effect of teneligliptin in type 2 diabetes patients.

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Increased Serum Levels of Uric Acid Are Associated with Sudomotor Dysfunction in Subjects with Type 2 Diabetes Mellitus

Experimental Diabetes Research ◽

10.1155/2011/346051 ◽

2011 ◽

Vol 2011 ◽

pp. 1-5 ◽

Cited By ~ 11

Author(s):

N. Papanas ◽

M. Demetriou ◽

N. Katsiki ◽

K. Papatheodorou ◽

D. Papazoglou ◽

...

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Uric Acid ◽

Colour Change ◽

Serum Levels ◽

Group A ◽

Group B

The aim of this paper was to assess serum uric acid (SUA) levels in patients with type 2 diabetes mellitus (T2DM) with or without sudomotor dysfunction (evaluated by the Neuropad test). We included 36 T2DM patients with sudomotor dysfunction (group A: mean age63.1±2.6years) and 40 age-, gender-, renal function- and T2DM duration-matched patients without sudomotor dysfunction (group B: mean age62.1±3.1years). SUA was significantly higher in group A (P<0.001). There was a significant correlation between SUA and Neuropad time to colour change in both groups (group A:rs=0.819,P<0.001; group B:rs=0.774,P<0.001). There was also a significant positive correlation between SUA and CRP in both groups (group A:rs=0.947,P<0.001; group B:rs=0.848,P<0.001). In conclusion, SUA levels were higher in T2DM patients with sudomotor dysfunction than those without this complication. The potential role of SUA in sudomotor dysfunction merits further study.

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Tumor Necrosis Factor Microsatellite Polymorphism Influences the Development of Insulin Dependency in Adult-Onset Diabetes Patients with the DRB1∗1502-DQB1∗0601 Allele and Anti-Glutamic Acid Decarboxylase Antibodies

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/jcem.85.9.6842 ◽

2000 ◽

Vol 85 (9) ◽

pp. 3348-3351

Author(s):

Hiroshi Obayashi ◽

Goji Hasegawa ◽

Michiaki Fukui ◽

Kenji Kamiuchi ◽

Akane Kitamura ◽

...

Keyword(s):

Type 2 Diabetes ◽

Tumor Necrosis ◽

Acid Decarboxylase ◽

Diabetic Patients ◽

Adult Onset ◽

Group A ◽

Group B ◽

Necrosis Factor

Abstract Recently, several studies have demonstrated that tumor necrosis factor microsatellite polymorphism (TNFa) contributes to the susceptibility of type 1 diabetes. This study investigates the influence of TNFa on the predisposition to insulin dependency in adult-onset diabetic patients with type 1 diabetes-protective human leukocyte antigen haplotypes. The TNFa of three groups of DRB1∗1502-DQB1∗0601-positive diabetic patients who had initially been nonketotic and noninsulin dependent for more than 1 yr was analyzed. Group A included 11 antibodies to glutamic acid decarboxylase (GADab)-positive patients who developed insulin dependency within 4 yr of diabetes onset. Group B included 11 GADab-positive patients who remained noninsulin dependent for more than 12 yr. Group C included 12 GADab-negative type 2 diabetes, and a control group included 18 nondiabetic subjects. In the group C and control subjects, DRB1∗1502-DQB1∗0601 was strongly associated with the TNFa13 allele. DRB1∗1502-DQB1∗0601 was strongly associated with the TNFa12 allele among the group A patients, but not among the group B patients. Interestingly, sera from all patients with non-TNFa12 and non-TNFa13 in group B reacted with GAD65 protein by Western blot. These results suggest that TNFa is associated with a predisposition to progression to insulin dependency in GADab/DRB1∗1502-DQB1∗0601-positive diabetic patients initially diagnosed with type 2 diabetes and that determination of these patients’ TNFa genotype may allow for better prediction of their clinical course.

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C-Reactive Protein Predicts Progression of Peripheral Arterial Disease in Patients with Type 2 Diabetes: A 5-Year Follow-Up Study

Journal of Medical Biochemistry ◽

10.2478/jomb-2014-0042 ◽

2014 ◽

Vol 33 (4) ◽

pp. 347-355

Author(s):

Ljiljana Popović ◽

Katarina Lalić ◽

Olga Vasović ◽

Danijela Drašković Radojković ◽

Nataša Rajković ◽

...

Keyword(s):

Type 2 Diabetes ◽

Peripheral Arterial Disease ◽

Arterial Disease ◽

C Reactive Protein ◽

Reactive Protein ◽

Group A ◽

Hs Crp ◽

Group B ◽

Peripheral Arterial

Summary Background: Previous studies have indicated that high sensitivity C-reactive protein (hs-CRP) is a risk factor for the peripheral arterial disease (PAD) in diabetes. This study aimed to evaluate the possible predictive significance of hs-CRP for the development and progression of PAD in patients with type 2 diabetes (T2D). Methods: The study included 80 patients previously diagnosed with T2D, aged 45–70 years, divided into group A (T2D patients with PAD; n=38) and group B (T2D patients without PAD; n=42). After five years, all the patients were re-examined and divided into subgroups depending on de novo development of PAD or progression of previously diagnosed PAD. Ankle-Brachial Index (ABI) measurement was used for PAD diagnosis and hs-CRP was determined by nephelometry. Results: We found significantly higher hs-CRP levels in group A compared to group B, but only at baseline. Among the patients in group A, those with later progression of PAD (subgroup A1) had the highest levels of hs-CRP at baseline, although not significantly different from those in subgroup A2 (non-progressors). In contrast, hs-CRP level was significantly higher in subgroup B1 (progressors) in comparison to subgroup B2 (non-progressors) at both the first and second exam. Of all the investigated metabolic parameters, hs-CRP was the only independent predictor of PAD progression (OR=0.456, 95% CI=0.267–0.7815, p=0.004). The cut-off point for hs-CRP was 2.5 mg/L (specificity 75% and sensitivity 73.3%) with the relative risk for PAD of 2.93 (95% CI=1.351–6.3629). Conclusions: Our study implies that hs-CRP can be used as a reliable predictor for the progression of PAD in patients with T2D.

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Clinical appraisal of Lodhradi Kashaya on type 2 diabetes mellitus patients

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20170310 ◽

2017 ◽

Vol 4 (1) ◽

pp. 58

Author(s):

Varun K. Singh ◽

K. R. C. Reddy

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Blood Glucose ◽

Dosage Form ◽

Dose Group ◽

Group A ◽

Group B

Background: Lodhradi Kashaya (LKSD) is basically ayurvedic kwath dosage form, described as Madhumehajeet (winner of diabetes mellitus) in ayurvedic classics Basavarajeeyam and the same formulation in Vaidya Chintamani and Charaka Samhita too. The aim of this study was to assess prospectively the drug’s ability in management of type 2 diabetes. Methods: Total 31 patients were taken following the guideline mention in CCRAS protocol for diabetes mellitus research. They are divided into two groups, group A and B, given LKSD 4 g & 2 g TDS respectively for three-month follow up. They are investigated against their blood glucose, HbA1C and liver profile tests. Patients were also investigated for subjective parameters viz polyurea, polyphagia, exhaustion and constipation and their response has also been noted regarding palatability acceptance and ease of administration.Results: Patients has responded positively for formulation. Decrease in FBS and PPBS were found highly significant (P ˂ 0.001) in both groups but more in higher dose (group A). Decrease in HbA1C is also found highly significant in both groups. In LFT, SGOT level were also decreased more in group B in comparison to group A, and it is significant (P = 0.017 and 0.002). SGPT level were also decreased more in group B in comparison to group A, and it is significant in group B (P= 0.085 and 0.002). Conclusions: LKSD is having astringent taste due to tannins and phenols in it. It was found significant not only in controlling blood sugar but also in management of other factors related to diabetes mellitus.

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Once daily versus twice daily Linagliptin effect on glycemic levels in type 2 diabetes mellitus- an observational study

International Journal of Research in Medical Sciences ◽

10.18203/2320-6012.ijrms20174567 ◽

2017 ◽

Vol 5 (10) ◽

pp. 4403

Author(s):

Riyaz Mohammed ◽

Mohammed Azfar Ali

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Observational Study ◽

Plasma Concentrations ◽

Fixed Dose ◽

Once Daily ◽

Group A ◽

Group B

Background: DPP-4 is widely distributed in endothelial cells, pancreas, uterus, liver, salivary glands, lymph node, spleen, and thymus. DPP-4 regulates glucagon-like peptide (GLP)-1, and glucose-dependent insulin tropic peptide (GIP) which leads to glucose homeostasis via enhancing insulin secretion and suppression of glucagon, which results in control of post-prandial and fasting hyperglycemia.Methods: These 40 patients who were enrolled as per the inclusion criteria of receiving metformin dosage of 2 gram per day in established type 2 diabetes mellitus patients with no comorbidities. these patients were divided randomly into two groups comprising of 20 patients each, group A received linagliptin 5 mg per day in addition to metformin 1gm twice daily whereas group B received linagliptin 5 mg per day in a fixed dose (Linagliptin + metformin) of 2.5/1000 twice daily.Results: In the present observational study, the mean age in group A was 46.7±9.4 compared to 51.65±9.9 in group B, p >0.05, mean BMI in group A was 27.8±1.1 compared to 27.28±0.93 in group B p >0.05, Mean FBS in group A was 157.9±24.1 compared to 146.2±21.8 in group B p >0.05, Mean PPBS in group A was 245.8±32.7 compared to 246.2±39.3 in group B p >0.05 and Mean HbA1c in group A was 7.67±0.58 compared to 7.6±0.5 in group B p >0.05. Group A patients were initiated on once daily linagliptin, there was a significant reduction in FBS, PPBS and HbA1c at the end of 6 months p <0.001. Similarly, Group B patients who were initiated on twice daily linagliptin also showed a significant reduction in FBS, PPBS and HbA1c at the end of 6 months p <0.001.Conclusions: The addition of linagliptin to metformin treatment was effective and well tolerated in patients with type 2 diabetes. Linagliptin add-on to metformin during the early course of treatment helps in delaying the exhaustion of pancreatic islet function. Plasma concentrations of linagliptin decline in at least a biphasic manner with a long terminal half-life (>100 hours), related to the saturable binding of linagliptin to DPP-4. The prolonged elimination phase does not contribute to the accumulation of the drug. Addition of linagliptin to metformin has shown a significant reduction in FBS, PPBS and HbA1c.

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Effectiveness of the Family Portal Function on the Lilly Connected Care Program (LCCP) for Patients With Type 2 Diabetes: Retrospective Cohort Study With Propensity Score Matching

JMIR mhealth and uhealth ◽

10.2196/25122 ◽

2021 ◽

Vol 9 (2) ◽

pp. e25122

Author(s):

Yiyu Zhang ◽

Chaoyuan Liu ◽

Shuoming Luo ◽

Jin Huang ◽

Yuxin Yang ◽

...

Keyword(s):

Type 2 Diabetes ◽

Blood Glucose ◽

Fasting Blood Glucose ◽

Postprandial Blood Glucose ◽

Self Monitoring ◽

The Family ◽

Group A ◽

Group B ◽

Education Courses

Background Diabetes is a major health concern worldwide. Family member engagement in diabetes self-management education programs can improve patients’ diabetes management. However, there is limited evidence that the family portal on diabetes management apps is effective in the glycemic control of patients with diabetes. Objective We aimed to evaluate the effectiveness of family support through the family portal function on Lilly Connected Care Program (LCCP) platform. Methods This retrospective cohort study included patients with type 2 diabetes recruited to the LCCP platform from September 1, 2018, to August 31, 2019. Propensity score matching was used to match family (group A) and non–family (group B) portal use groups with similar baseline characteristics. The patients were followed up with for 12 weeks. The main objectives were differences in mean fasting blood glucose, proportion of patients achieving fasting blood glucose target <7mmol/L, mean postprandial blood glucose, proportion of patients achieving postprandial blood glucose target <10mmol/L, proportion of patients achieving both fasting blood glucose <7mmol/L and postprandial blood glucose <10mmol/L, self-monitoring of blood glucose frequency at week 12 and the number of diabetes education courses patients completed during the 12 weeks. Moreover, logistic regression analysis was used to explore the baseline factors which may be associated with the use of family portal, and odds ratios with 95% confidence intervals were calculated. Results A total of 6582 adult patients (aged ≥18 years) with type 2 diabetes who were receiving insulin therapy were enrolled in the study. Overall, 6.1% (402/6582) of the patients chose to engage their family members to use the family portal. Two groups of 394 patients were well-matched regarding baseline characteristics. After matching, mean fasting blood glucose and postprandial blood glucose at week 12 were significantly lower in group A than in group B (fasting blood glucose: 7.12 mmol/L, SD 1.70 vs 7.42 mmol/L, SD 1.88, respectively, P=.02; postprandial blood glucose: 8.56 mmol/L, SD 2.51 vs 9.10 mmol/L, SD 2.69, respectively, P=.002). When comparing group A to group B, the proportion of patients achieving both fasting blood glucose <7mmol and postprandial blood glucose <10mmol/L at week 12 (46.8% vs 39.4%, respectively, P=.04), self-monitoring of blood glucose frequency at week 12 (8.92 times per week, SD 6.77 vs 8.02 times per week, SD 5.97, respectively, P=.05) and number of diabetes education courses completed in 12 weeks (23.00, IQR9.00-38.00 vs 15.00, IQR 4.00-36.00, respectively, P<.001) was higher. Additionally, multivariate logistic regression analysis showed that higher age (OR=0.987, 95% CI 0.978-0.996, P=.006) and higher baseline fasting blood glucose (OR=0.914, 95% CI 0.859-0.972, P=.004) were correlated with less use of the family portal function, while increased baseline self-monitoring of blood glucose frequency (OR=1.022, 95% CI 1.012-1.032], P<.001) as well as increased education courses (OR=1.026, 95% CI 1.015-1.036, P<.001) were associated with more use of the family portal function. Conclusions Family support through the LCCP family portal is effective for glycemic control and self-management behavior improvement in type 2 diabetes patients.

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Comparison of the clinical manifestations between different age groups of patients with overseas imported COVID-19

PLoS ONE ◽

10.1371/journal.pone.0243347 ◽

2020 ◽

Vol 15 (12) ◽

pp. e0243347

Author(s):

Yujuan Han ◽

Zujin Luo ◽

Wenliang Zhai ◽

Yue Zheng ◽

Huan Liu ◽

...

Keyword(s):

Type 2 Diabetes ◽

Clinical Symptoms ◽

Demographic Data ◽

Disease Onset ◽

Age Groups ◽

Clinical Manifestations ◽

Symptom Improvement ◽

Group A ◽

Group B

The current study investigated the clinical manifestations and outcomes of different age groups of patients with overseas imported COVID-19. In total, 53 COVID-19 patients admitted to the designated Beijing Xiaotangshan Hospital between March 16 and April 15 of 2020 were included. Based on the percentage of disease aggravation during hospital stay according to CT, the patients were divided into two groups: ≤40 years (group A; n = 41) and >40 years (group B; n = 12). The demographic data, epidemiological history, disease courses, potential complications, clinical symptoms, lab indices, chest CT outcomes, treatment protocols and turnovers of the two groups were compared. According to clinical typing, compared with group A, group B had a significantly greater proportion of the common type of COVID-19 (P<0.05) and greater comorbidity of type 2 diabetes (P<0.001). The two groups presented significantly different lab indices. Group B showed significantly more frequent CT abnormalities, with greater proportions of multiple lesions and bilateral lung involvement (P<0.05). During hospitalization, group B had a greater proportion of disease aggravation according to CT (P<0.01). Compared with group A, group B received a significantly greater proportion of antiviral therapy and presented a significantly greater occurrence of adverse drug reactions (P<0.05). The two groups did not significantly differ in time from admission to clinical symptom improvement or from disease onset to negative outcomes according to nucleic acid testing, the appearance of IgG or the appearance of IgM. They also did not significantly differ in length of stay. Older imported COVID-19 patients, particularly those with type 2 diabetes, showed a broader pulmonary extent and faster development of the disease, more severe pathogenetic conditions and a greater risk of developing a critically severe type. Increased attention should be given to this population in clinical practice.

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Efficacy and Safety of Empagliflozin as Add-On Therapy in Patients of Type-2 Diabetes Mellitus

Journal of Gandhara Medical and Dental Science ◽

10.37762/jgmds.9-1.173 ◽

2022 ◽

Vol 9 (1) ◽

pp. 24-27

Author(s):

Nauman Wazir ◽

Shafqat Ur Rehman

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Side Effects ◽

Glycaemic Control ◽

Group A ◽

Group B ◽

Tract Infections ◽

Mycotic Infections

OBJECTIVES: To assess efficacy of two doses i.e., 10 mg and 25 mg in lowering the glycated haemoglobin (HbA1C) and fasting blood glucose (FBG) in patients of type 2 diabetes mellitus (T2DM) having suboptimal glycaemic control on maximal doses of Metformin and Sitagliptin, and to see the frequency of its side-effects. METHODOLOGY: The study design was a randomized control trial. Fifty nine adult patients of T2DM who were already on 2000 mg of Metformin and 100 mg of Sitagliptin and were having suboptimal glycaemic control (HBA1C >7% and <12%) were randomized to two groups, one group receiving 10 mg (Group A) and the other group receiving 25 mg of empagliflozin (Group B) as an additional treatment. HbA1C and FBG were taken before and 12 weeks after addition of empagliflozin in both the groups. Side effects of empagliflozin such as urinary tract infections (UTI) and genital mycotic infections were also recorded in both the groups. RESULTS: Total patients in-group A were 31 and their mean age was 51.48±4.29 years. In-group B there were 28 patients and their mean age was 52.39±5.20 years. There was a statistically significant reduction of both HbA1C and FBG in both the groups after empagliflozin treatment; (p=0.000) for both HbA1C and FBG in both the groups. Although numerically UTI and genital mycotic infections were more than pre-treatment numbers, they were not statistically significant (p>0.05). CONCLUSION: Empagliflozin can be safely added to the oral anti-diabetic regimen of patients with type 2 diabetes mellitus who have suboptimal glycaemic control and results in significant improvement in HbA1C.

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