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

2020 ◽  
Vol 17 ◽  
Author(s):  
Anand Shankar

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

2018 ◽  
Vol 2018 ◽  
pp. 1-9
Author(s):  
Shuo Lin ◽  
Mu Chen ◽  
Wanling Chen ◽  
Keyi Lin ◽  
Panwei Mu ◽  
...  

Aims. Basal insulin plus oral hypoglycemic agents (OHAs) has not been investigated for early intensive antihyperglycemic treatment in people with newly diagnosed type 2 diabetes. This study is aimed at comparing the short-term (over a period of 12 days) effects of basal insulin glargine plus OHAs and continuous subcutaneous insulin infusion (CSII) on glycemic control and beta-cell function in this setting. Methods. An open-label parallel-group study. Newly diagnosed hospitalized patients with type 2 diabetes and fasting plasma glucose (FPG) ≥11.1 mmol/L or glycated hemoglobin (HbA1c) ≥9% (75 mmol/mol) were randomized to CSII or insulin glargine in combination with metformin and gliclazide. The primary outcome measure was the mean amplitude of glycemic excursions (MAGE), and secondary endpoints included time to reach glycemic control target (FPG < 7 mmol/L and 2-hour postprandial plasma glucose < 10 mmol/L), markers of β-cell function, and hypoglycemia. Results. Subjects in the CSII (n=35) and basal insulin plus OHA (n=33) groups had a similar significant reduction from baseline to end of treatment in glycated albumin (−6.44 ± 3.23% and− 6.42 ± 3.56%, P=0.970). Groups A and B have comparable time to glycemic control (3.6 ± 1.2 days and 4.0 ± 1.4 days), MAGE (3.40 ± 1.40 mmol/L vs. 3.16 ± 1.38 mmol/L; p=0.484), and 24-hour mean blood glucose (7.49 ± 0.96 mmol/L vs. 7.02 ± 1.03 mmol/L). Changes in the C-peptide reactivity index, the secretory unit of islet in transplantation index, and insulin secretion-sensitivity index-2 indicated a greater β-cell function improvement with basal insulin plus OHAs versus CSII. Conclusions. Short-term insulin glargine plus OHAs may be an alternative to CSII for initial intensive therapy in people with newly diagnosed type 2 diabetes.


2021 ◽  
Vol 8 (12) ◽  
pp. 1817
Author(s):  
Vishal Kumar Gupta ◽  
Richa Giri ◽  
Saurabh Agrawal

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.


2011 ◽  
Vol 2011 ◽  
pp. 1-5 ◽  
Author(s):  
N. Papanas ◽  
M. Demetriou ◽  
N. Katsiki ◽  
K. Papatheodorou ◽  
D. Papazoglou ◽  
...  

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.


2000 ◽  
Vol 85 (9) ◽  
pp. 3348-3351
Author(s):  
Hiroshi Obayashi ◽  
Goji Hasegawa ◽  
Michiaki Fukui ◽  
Kenji Kamiuchi ◽  
Akane Kitamura ◽  
...  

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.


2014 ◽  
Vol 33 (4) ◽  
pp. 347-355
Author(s):  
Ljiljana Popović ◽  
Katarina Lalić ◽  
Olga Vasović ◽  
Danijela Drašković Radojković ◽  
Nataša Rajković ◽  
...  

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.


2017 ◽  
Vol 4 (1) ◽  
pp. 58
Author(s):  
Varun K. Singh ◽  
K. R. C. Reddy

<p class="abstract"><strong>Background:</strong> <span lang="EN-IN">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. </span></p><p class="abstract"><strong>Methods:</strong> <span lang="EN-IN">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 &amp; 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.</span></p><p class="abstract"><strong>Results:</strong> <span lang="EN-IN">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).  </span></p><p class="abstract"><strong>Conclusions:</strong> 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.</p>


Author(s):  
Riyaz Mohammed ◽  
Mohammed Azfar Ali

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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