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

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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Comparison of Efficacy and Safety of Sitagliptin and Glimepiride in Treatment of Type 2 Diabetes Mellitus

10.53350/pjmhs2115102800 ◽

2021 ◽

Vol 15 (10) ◽

pp. 2800-2803

Author(s):

Shabir Hussain ◽

Amjad Mustafa ◽

Arif Mumtaz ◽

Ghazala Shaheen ◽

Fawad Qaiser ◽

...

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Side Effects ◽

Drop Out ◽

Efficacy And Safety ◽

Significant Drop ◽

Group A ◽

Group B

Objective: To compare the efficacy and safety of sitagliptin and glimepiride in treatment of type 2 diabetes mellitus. Design: It was an observational open comparative study. Study Settings: This study was conducted at Department of Pharmacology over 1 year from March 2017 to March 2018 at DHQ Teaching Hospital, Kohat. Material and Methods: Sixty (60) patients were enrolled in the study meeting the inclusion criteria. Tablet glimipiride 1 mg and sitagliptin 100 mg was used as the treatment option. Patients were randomly divided into two groups: group Glimepiride (30 patients; administered glimepiride 2 mg daily) and group Sitagliptin (30 patients; administered sitagliptin 100 mg daily). If glycemic control was not reached then patient was excluded from the study and given further treatment for benefit of the patient. The samples of blood were taken at 12 weeks visit to test HbA1c level, fating blood sugar (FBG) and post prandial glucose (PPG) level. At the time of follow up patient were evaluated for efficacy, safety and tolerability. All collected data was entered then analysed in SPSS version 19.0. Results: A total of 60 patients were enrolled into the study, with 30 in each group. Mean age in sitagliptin group (A) was 45 years, while that of glimeperide group (B) was 47 years. There were 16 males and 14 females in group A, 18 males and 12 females in group B. We found a significant reduction of HbA1C and BMI in group S taking sitagliptin as compared to glimeperide group. (p<0.05) Reduction in FBS was comparable in both the groups. (p>0.05). Side effects in both the groups mostly included hypoglycemia, and vomiting, nausea and abdominal pain. These side effects were mild and did not need stoppage of medication or resulted in drop outs. Conclusion: Sitagliptin as an adjunct to present monotherapy with metformin showed significant drop out in HbA1c, PPG and FBG values after treatment of 12 weeks and was non inferior to glimepiride. However, no sitagliptin taking patients observed any episodes of hypoglycemia. Also weight loss was observed in sitagliptin group as compared to glimepiride group.. Keywords: Glimepiride, Sitagliptin, Efficacy, Safety, Type 2 Diabetes Mellitus

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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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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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Comparison of the efficacy and safety of Glimepiride and Glipizide as add-on therapy with metformin in patients of type 2 diabetes mellitus

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20170835 ◽

2017 ◽

Vol 6 (3) ◽

pp. 675

Author(s):

Madhuri Chatterjee ◽

Taruna Sharma ◽

Anita Sharma ◽

Juhi Kalra

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Glycaemic Control ◽

Tertiary Care ◽

Care Hospital ◽

Efficacy And Safety ◽

Significant Difference ◽

Group B

Background: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder carrying an enormous burden of morbidity and mortality because of its characteristic complications, many of which are preventable with strict glycaemic control. Initial management of T2DM consists of non-pharmacological interventions; it those fail, an oral anti-diabetic drug, most typically metformin, is started. Combination therapy is initiated only when monotherapy fails to achieve glycaemic control. Glipizide and glimepiride, a second and a third generation sulphonylurea respectively, are the commonest drugs added to metformin when the latter fails to achieve euglycaemia on its own. Aims and Objectives of the study were to compare the efficacy and safety of glimepiride and glipizide as add-on therapy to metformin in patients of uncontrolled T2DM.Methods: This prospective, observational and analytical study was conducted by the Department of Pharmacology among patients attending the Internal Medicine OPD of a tertiary-care hospital. Fifty patients were assigned to two groups of 25 patients each: Group A - Glimepiride + Metformin and Group B - Glipizide + Metformin. Patients were followed up for three months. Data were analysed by Student's t-test.Results: There was a significant decrease in the HbA1c, FBS and 2h-PPBS in both groups. However there was no significant difference between the two groups during the three-month period of follow-up.Conclusions: The combination of glimepiride and metformin is just as effective and safe as the combination of glipizide and metformin in patients not controlled on monotherapy with metformin.

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Type 2 diabetes mellitus status in obese patients following sleeve gastrectomy or one anastomosis gastric bypass

Scientific Reports ◽

10.1038/s41598-021-83807-8 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Gavriella Zoi Vrakopoulou ◽

Charalampos Theodoropoulos ◽

Vasileios Kalles ◽

George Zografos ◽

Konstantinos Almpanopoulos

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Weight Loss ◽

Gastric Bypass ◽

Type 2 Diabetes Mellitus ◽

Obese Patients ◽

Group A ◽

Insulin Dependent ◽

Group B

AbstractThis study aims to compare sleeve gastrectomy (SG) and one anastomosis gastric bypass (OAGB) in terms of remission of type 2 diabetes mellitus (T2DM) in obese patients. All T2DM patients were followed-up for at least 36 months. The primary outcome was remission of T2DM. Secondary endpoints included weight reduction and the procedure’s impact on quality of life. In total, 53/1177 morbidly obese patients who underwent SG (Group A, n = 28) or OAGB (Group B, n = 25) had T2DM. Preoperatively, the mean Body Mass Index (BMI) values were 52.2 ± 8.5 kg/m2 and 52.9 ± 10.9 kg/m2 for Group A and Group B, respectively. Six patients in Group A were insulin dependent, while 8 were insulin dependent in Group B. After 36 months, diabetes remission was achieved by only 10 patients (35.7%) in Group A. However, in Group B, 22 patients (88%) remained off antidiabetic agents (p < 0.0001), with ΔHbA1c (%) reaching 1.4 ± 1.5% in Group A and 2.7 ± 2.1% in Group B (p = 0.02). Excess weight loss% (%EWL) was again significantly different between the two groups (MA = 79.8 ± 14.5%, MB = 93.3 ± 16.0%, p = 0.003). OAGB is more effective in improving glycaemic control and %EWL, with almost immediate resolution of diabetes, as well as long-term weight loss.

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Tumour Necrosis Factor-α Levels in Non-Diabetic Offspring of Patients with Type 2 Diabetes Mellitus

Journal of International Medical Research ◽

10.1177/147323000203000605 ◽

2002 ◽

Vol 30 (6) ◽

pp. 576-583 ◽

Cited By ~ 9

Author(s):

E Maltezos ◽

D Papazoglou ◽

T Exiara ◽

L Papazoglou ◽

E Karathanasis ◽

...

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Tumour Necrosis Factor Α ◽

Tnf Α ◽

Group A ◽

Group B ◽

Factor Α ◽

Necrosis Factor

Tumour necrosis factor-α (TNF-α) is considered to be involved in the insulin resistance of type 2 diabetes mellitus. The offspring of patients with type 2 diabetes mellitus are at increased risk of developing diabetes and several metabolic abnormalities, but the underlying defects responsible are not known. We studied serum TNF-α levels in 30 healthy non-diabetic offspring of type 2 diabetic parents (group A), and the relationship between TNF-α levels and variables associated with insulin resistance and diabetes. For comparison, 30 healthy offspring of non-diabetic parents (group B) were also studied. The median serum concentration of TNF-α was significantly higher in group A than in group B, 3.5 pg/ml compared with 2.0 pg/ml, respectively. The individuals of group A also had significantly elevated levels of glycosylated haemoglobin, fasting glucose, glucose 2 h after an oral glucose tolerance test and triglycerides. We conclude that serum TNF-α concentration is significantly elevated in non-diabetic offspring of type 2 diabetics and this may predict later impairment of insulin action in these individuals.

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SITAGLIPTIN;

The Professional Medical Journal ◽

10.29309/tpmj/2017.24.11.675 ◽

2017 ◽

Vol 24 (11) ◽

pp. 1755-1760

Author(s):

Zaheer Ahmed ◽

Hassan Fareed ◽

Muhammad Usman Musharraf

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Blood Sugar ◽

T Test ◽

P Value ◽

Diabetic Patients ◽

Group A ◽

Group B

The objective of this stidy is to compare the mean reduction of HbA1c in patientstaking sitagliptin insulin combination with insulin alone in patients of type II Diabetes mellitus.Study Design: Randomized control trial (RCT). Setting: Medicine Department, Allied Hospital,Faisalabad. Period: August 2013 to February 2014. Methodology: Patients of both genderswith ages between 18 and 60 years having uncontrolled type 2 diabetes mellitus with HbA1ctaking insulin were included in the study while Pregnant or lactating mothers, patients withchronic liver disease and patients with renal insufficiency (creatinine >3.0mg/dl) were excludedfrom study. Patients were randomly divided into two groups (A &B) using computer generatedrandom number table. Group A was given Sitagliptin 50mg per day and dose was increasedto 100mg per day after 2 weeks if fasting blood sugar was more than 110mg/dl or 2 hourspostprandial blood sugar more than 140mg/dl. Dose of insulin in group A remained same asbefore start of study. Group B was kept on same regimen of insulin they were already taking anddose remained same. HbA1c was done at start of study and after 24 weeks. Primary outcomemeasure was mean reduction in HbA1c levels at 24 weeks from baseline. Results: 60 patientswere included in the study. Mean age was 52.7+8.43 years. 36(60%) were male and 24(40%)were female. Mean HbA1c at baseline was 8.361+0.523% in Group A on Sitagliptin-insulincombination and 8.187+0.432% in group B on insulin alone. Mean HbA1c at 24 weeks was7.767+0.428% in group A on Sitagliptin-insulin combination and 7.69+0.407% in group B oninsulin alone.Independent sample t-test was applied to change in HbA1c in Group A and Bduring 24 weeks of treatment. Mean change in HbA1c after 24 weeks in Group A was 0.600+ 0.315 and 0.49+ 0.19 in Group B after 24 weeks treatment (p-value 0.002) which is highlysignificant. Paired sample t-test was applied to HbA1c at baseline and 24 weeks of treatmentin group A and group B. There was a significant change in both groups after 24 weeks oftreatment in both groups (p-value <0 .000) which is highly significant. Chi Square test wasapplied on efficacy in group A and B. 22(73.33%) patients in group A and 14(46.67%) patientsin group B which achieved significant reduction in HbA1c. 8(26.67%) patients in group A and16(53.33%) patients in group B failed to achieve significant reduction in HbA1c. (P-value <0.032). Conclusion: It has been concluded from this study that insulin and sitagliptin-insulincombination both significantly reduce HbA1c in type 2 diabetes mellitus. However addition ofsitagliptin to uncontrolled diabetic patients already taking insulin, is more effective than insulinfor glycemic control of patients with type 2 diabetes mellitus.

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A study to analyze the effectiveness of Swiss ball exercise versus resistance training in type 2 diabetes mellitus

Biomedicine ◽

10.51248/.v41i2.1065 ◽

2021 ◽

Vol 41 (2) ◽

pp. 493-497

Author(s):

Kamatchi Kaviraja ◽

Arimbit K. Sangma ◽

Priya Kumara ◽

N. Kaviraja ◽

S.Jennifer Agustina

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Resistance Training ◽

Dietary Pattern ◽

Exclusion Criteria ◽

Group A ◽

Group B ◽

Swiss Ball

Introduction and Aim: Diabetes is a disease rising all over the world affecting larger number of populations. In India largest number of diabetic patients are reported. Lack of physical activity, dietary pattern change, and sedentary life style are the major causes for concern. Aneffective lifestyle intervention including changes in dietary pattern, regular exercises would enhance in preventing or postponing the onset of diabetes. The aim of the study is to analyse the effectiveness of Swiss ball exercise and resistance training in type 2 diabetes mellitus patients. Materials and Methods:The study design is comparative type. The study was conducted in Faculty of Physiotherapy, Dr. MGR Educational and Research Institute, Chennai. The study sample of 30 subjects both male and female were selected based on the inclusion and exclusion criteria. The subjects were sorted into two groups.Inclusion criteria were patients with clear history of Type 2 diabetes, clinically diagnosed, an inactive lifestyle, age between 30-60 years. Exclusion criteria were uncontrolled hypertension, coronary artery disease, advanced retinopathy, neuropathy, severe orthopedic conditions. 30 subjects between the age group of 30-60 years were divided into two groups, group A and group B. Individuals in the group A (n=15) received the Swiss ball exercise and group B (n=15) received resistance training exercise for 5 session/ week for 12 weeks for 30 minutes. Results: On comparing pre-test and post-test within group A andgroup B on fasting, post prandial blood sugar level and diabetes distress screening scale show highly significant difference in mean values at P ? 0.001. Conclusion:The study concluded that both the groupshad substantial effect. On comparing Swiss ball exercise and resistance training, both the exercise programs were found to be equally effective.

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