Real-World Clinical Effectiveness and Tolerability of Hydroxychloroquine 400 Mg in Uncontrolled Type 2 Diabetes Subjects who are not Willing to Initiate Insulin Therapy (HYQ-Real-World Study)

2019 ◽  
Vol 15 (6) ◽  
pp. 510-519 ◽  
Author(s):  
Amit Gupta

Objective: The epidemic of T2DM is rising across the globe. Systemic inflammation plays a pivotal role in the pathogenesis and complications of T2DM. Combination of two or more oral hypoglycemic agents (OHA) is widely prescribed in patients with T2DM, however many patients have poor glycemic control despite receiving combination therapy. The new antidiabetic drugs are relatively costly or many patients have anxiety over the use of injectable insulin. The objective of this observational study was to investigate the effectiveness and tolerability of hydroxychloroquine (HCQ) in T2DM patients uncontrolled on multiple OHA and despite high sugar level not willing to initiate insulin therapy in a real-world clinical setting. Methods: A prospective, investigator-initiated, observational, single-centred study was conducted where 250 patients (18-65 years) with T2DM for more than 5 years, with uncontrolled glycemia despite on a combination of multiple OHA, HbA1c between ≥7% and <10.5%, FPG >130 mg/dL or PPG >180 mg/dL and BMI between >25 and <39 kg/m2, were prescribed hydroxychloroquine sulphate 400 mg once daily for 48 weeks. Percentage of drugs used at the baseline were as follows: metformin 2000 mg (100%), glimepiride 4 mg (100%), pioglitazone 30 mg (100%), sitagliptin 100 mg (100%), canagliflozin 300 mg (52.4%), empagliflozin 25 mg (22.8%), dapagliflozin 10 mg (17.6%) and voglibose 0.3 mg (62%). Mean change in HbA1c, blood glucose and hs-CRP at baseline, week 12, 24 and 48 were assessed using the paired t-test. Results: After 48 weeks of add-on treatment with HCQ, almost all SGLT-2 inhibitors were withdrawn; metformin dose was reduced to 1000 mg, glimepiride reduced to 1 mg and sitagliptin reduced to 50 mg OD. Patients continued to have good glycemic control. HbA1c was reduced from 8.83% to 6.44%. Reduction in FPG was 40.78% (baseline 177.30 mg/dL) and PPG was reduced by 58.95% (baseline 329.86 mg/dL). Change in mean body weight was -4.66 Kg. The reduction in glycemic parameters and mean body weight was significant (p < 0.0001). Hs-CRP was significantly reduced from 2.70±1.98 mg/L to 0.71±0.30 mg/L 9 (p < 0.0001). More reduction in glycemic parameters and body weight was observed among the patients with higher hs-CRP (> 3 mg/L) as compared to patients with baseline hs- CRP ≤ 3 mg/L. Most common adverse events reported with the drug therapy were GI irritation (3.6%) and hypoglycemia (2%). None of the patients required medical assistance for hypoglycemia. Conclusion: Add-on treatment of HCQ effectively improved glycemic control in T2DM patients uncontrolled on multiple antidiabetic drugs. By virtue of its antidiabetic and anti-inflammatory properties, it may emerge as a valuable therapeutic intervention for the patients with T2DM.

2012 ◽  
Vol 56 (7) ◽  
pp. 405-414 ◽  
Author(s):  
Carlos Antonio Negrato ◽  
Renan Magalhães Montenegro Junior ◽  
Lilia Maria Von Kostrisch ◽  
Maria Fatima Guedes ◽  
Rosiane Mattar ◽  
...  

Pregnancy affects both maternal and fetal metabolism, and even in non-diabetic women, it exerts a diabetogenic effect. Among pregnant women, 2% to 14% develop gestational diabetes. Pregnancy can also occur in women with preexisting diabetes, which may predispose the fetus to many alterations in organogenesis, restrict growth, and the mother, to some diabetes-related complications, such as retinopathy and nephropathy, or to acceleration of the course of these complications, if they are already present. Women with gestational diabetes generally start their treatment with diet and lifestyle changes; when these changes are not enough for optimal glycemic control, insulin therapy must then be considered. Women with type 2 diabetes using oral hypoglycemic agents are advised to change to insulin therapy. Those with preexisting type 1 diabetes should start intensive glycemic control. As basal insulin analogues have frequently been used off-label in pregnant women, there is a need to evaluate their safety and efficacy. The aim of this review is to report the use of both short- and long-acting insulin analogues during pregnancy and to enable clinicians, obstetricians, and endocrinologists to choose the best insulin treatment for their patients.


2016 ◽  
Vol 9 ◽  
pp. CMED.S38077 ◽  
Author(s):  
Wafaa AlSaggaf ◽  
Mohammed Asiri ◽  
Balgees Ajlan ◽  
Alaa Bin Afif ◽  
Roaa Khalil ◽  
...  

Aim To compare the effect of different treatment regimens (oral hypoglycemic agents [OHGs], insulin therapy, and combination of both) on glycemic control and other cardiometabolic risk factors in type 2 diabetes mellitus (T2DM) patients in Saudi. Subjects and Methods Patients with T2DM, but no serious diabetic complications, were randomly recruited from the diabetes clinics at two large hospitals in Jeddah, Saudi Arabia, during June 2013 to July 2014. Only those without change in treatment modality for the last 18 months were included. Blood pressure and anthropometric measurements were measured. Treatment plan was recorded from the patients' files. Fasting blood sample was obtained to measure glucose, HbA1c, and lipid profile. Results A total of 197 patients were recruited; 41.1% were men and 58.9% were women. The mean (±SD) age was 58.5 ± 10.5 years. Most patients (60.7%) were on OHGs, 11.5% on insulin therapy, and 27.7% were using a combination of insulin and OHGs. The mean HbA1c was lower in patients using OHGs only, compared with means in those using insulin, or combined therapy in patients with disease duration of #10 years ( P = 0.001) and also in those with a longer duration of the disease ( P < 0.001). A lower mean diastolic and systolic blood pressure was found among patients on insulin alone ( P < 0.01). No significant differences were found in lipid profiles among the groups. Conclusion Insulin therapy, without adequate diabetes education, fails to control hyperglycemia adequately in Saudi T2DM patients. There is a challenge to find out reasons for poor control and the ways as to how to improve glycemic control in T2DM.


Author(s):  
PanPan Zuo ◽  
JianFeng Shi ◽  
Juan Yan ◽  
LiHong Yang ◽  
Chao Liu ◽  
...  

Abstract Objective The purpose of the study was to compare glycemic control in patients with type 2 diabetes (T2DM) receiving insulin therapy (IT) or oral hypoglycemic agents (OHA), and explore associations between treatment modality and pancreatic beta-cell function. Methods A matched, case-control study was conducted from April, 2016 to November, 2016. 2 272 patients with T2DM were identified from electronic medical records at four academic hospitals in China. Based on 1 136 eligible patients using IT, eligible 1 136 OHA patients were matched by age and duration at a ratio of 1:1. Logistic regression was used to examine the relationship between IT and glycemic control. Multiple linear regression addressed impact factors of HOMA-β. Results There was no significant difference between IT and OHA groups in gender, age, diabetes duration, body mass index (BMI), fasting plasma glucose (FPG), systolic blood pressure (SBP), serum lipids and smoking history (p>0.05). We stratified subjects by diabetes duration, only when the duration was less than 5 years, HbA1c in OHA group was superior to IT (P=0.017). There were no significant differences between groups in HbA1c when disease duration was≥5 years. Even in subjects with short diabetes duration (<5 years), IT did not significantly impact glycemic control (p=0.071, OR=0.577). Multiple linear regression analysis showed that IT (p=0.001), diabetes duration (p=0.038), BMI (P<0.001), sulfonylurea use (P=0.001) were significant and independent predictors of HOMA-β. Conclusions In patients with short diabetes duration (<5 years), oral hypoglycemic therapy achieved better glycemic control than insulin therapy. Moreover, insulin use was not an impact factor of poor glycemic control. In addition, using insulin can protect beta-cell function.


2009 ◽  
Vol 05 (01) ◽  
pp. 40
Author(s):  
Morali D Sharma ◽  
Alan J Garber ◽  
◽  

Initiating insulin therapy is an important step in the management of patients with type 2 diabetes. The insulin regimen prescribed should be physiological and designed to control fasting and post-prandial glucose levels. The primary goals of therapy are achieving and maintaining tight glycemic control. The optimal insulin regimen should be patient-specific, taking the patient’s lifestyle into consideration. As their diabetes progresses, an increasing number of patients require insulin therapy. An initial approach is to add basal insulin to oral hypoglycemic agents. When this regimen fails to achieve glycemic control, it should be intensified by either adding a rapid-acting insulin analog to control postprandial hyperglycemia or switching to pre-mixed insulin injection initiated once daily and subsequently up to three times daily. More tools are now available, including injection devices, insulin pens, glucose monitoring devices, and insulin pumps, to overcome the barriers to initiating and intensifying insulin therapy. With new insulin analogs it is possible to intensify insulin therapy to achieve glycemic control targets without increasing the risk for hypoglycemia or causing excessive weight gain.


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.


Author(s):  
Leena Das ◽  
Bijay Kumar Meher ◽  
Sagar Parida ◽  
Deepti Damayanty Pradhan ◽  
Lucy Das ◽  
...  

Background: Insulin has been the primary mode of therapy in diabetic mother for glycemic control as oral hypoglycemic agents (OHA) were initially thought to have teratogenic effect. Recent data supports the use of certain OHA; this study was designed to compare the perinatal outcomes in infants born to diabetic mother treated with insulin vs. oral hypoglycemic agents and to find out the relation of adverse perinatal events to glycemic control in both groups.Methods: This prospective observational study was conducted in a tertiary care hospital. 108 neonates born to diabetic mother between October 2014 to September 2016 were taken for study immediately after delivery after excluding the mothers who were treated with lifestyle modification and/or dietary modification alone only. 60 mothers had received insulin and 48 OHA for glycaemic control. Glycemic control was assessed by HbA1C estimation on the day of delivery. The infants were followed up in neonatal care unit for perinatal complications. Main outcome measure(s): birth weight, gestational age, respiratory problems, birth injury, birth asphyxia, congenital anomalies, hypoglycemia, hypocalcaemia, hyperbillirubinemia.Results: Out of 108 infants, 27 were born to pregestational and 81 to gestational diabetic mothers. 60(55.5%) were treated with insulin and rest with OHA, 53(49.1%) had optimal glycemic control. Both the groups had similar glycemic control in the third trimester. None of the perinatal outcomes showed significant difference between insulin and OHA group except neonatal hyperbillirubinemia. (p=0.013, RR=8 and OR=0.106). Within the optimal glycemic control (HbA1C <8), LGA has significant association with the insulin group than OHA (p=0.012, RR=2.217 and OR=4.2018).Conclusions: As compared to insulin, oral hypoglycemic agents have similar glycemic control and no adverse perinatal outcomes and can be used in pregnant mothers with diabetes mellitus from poor socioeconomic and educational background for its low cost and better patient compliance. Within the glycemic control, maternal treatment with insulin showed significant difference in LGA compared to OHA which needs further studies for validation.


2021 ◽  
Vol 8 (3) ◽  
pp. 205-207
Author(s):  
Abhijit Trailokya ◽  
Amol Aiwale ◽  
Roshan Pawar ◽  
Suhas Erande

This study aimed to assess effectiveness and safety of Evogliptin 5 mg in patients with T2DM who were prescribed Evogliptin alone or with other oral hypoglycemic agents in real world scenario. Overall 20 patients who received Evogliptin as routine clinical practice in management of T2DM were analyzed retrospectively from single center. Data collected from past medical records. Primary endpoint was mean changes in HbA1c from baseline to weeks 24 and secondary endpoints were Change in HbA1c from baseline to weeks 12 Change from baseline in FPG & PPG at weeks 12 & 24.Significant reduction in HbA1c at the end of 12 and 24 weeks of Evogliptin therapy was - 0.9% and -1.45% respectively from the baseline of HbA1c 8.6% (p value &#60;0.001). At the end of 12 and 24 weeks of addition of Evogliptin, significant reduction in FBG were seen i.e -49.5 mg/dl and -90.7mg/dl respectively from base line of 182 mg/dl and reduction in PPG was -79.4mg/dl and -116.6mg/dl respectively from base line 277 mg/dl (p value &#60;0.001). Evogliptin was found to be effective when added to the patients who were uncontrolled on dual / triple oral anti-diabetic medications and even in treatment naïve patient. It effectively showed reduction in HbA1c, FBG and PPG and the end of 12 and 24 weeks when added to existing anti-diabetic medications & well tolerated in type 2 diabetes Indian patients.Small sample size and retrospective study


2012 ◽  
Vol 58 (3) ◽  
pp. 56-60
Author(s):  
I R Iarek-Martynova

The onset of insulin therapy is an important stage in the treatment of type 2 diabetes mellitus. Its timely beginning ensures better control of glycemia and reduces the negative consequences of chronic glucose cytotoxicity and lipotoxicity. The achievement and maintenance of the stable compensation of the disease are the indispensable conditions for successful prophylaxis and adequate treatment of chronic complications of diabetes mellitus. The ADA guidelines recommend to initiate insulin therapy at the early stages of the disease provided it is dictated by the clinical situation or combine it with the use of oral hypoglycemic agents if the targeted HbA1c levels fail to be reached despite the intake of one or more tableted preparations.


Author(s):  
N. B. Zelinska ◽  
K. V. Grishchenko ◽  
E. V. Globa

Introduction. Recently, many studies have been devoted to the study of type 2 diabetes mellitus (DM2) worldwide. In most countries of the world, the increase in the prevalence of DM2 among children and adolescents is accompanied by an increase in childhood obesity. The presence of obesity or overweight in children can complicate the diagnosis of various types of DM. Detection and treatment of DM2 is extremely important for the society due to the wide range of severe diabetes complications.The aim of this work was to analyze the frequency of DM2 according to the Register of patients with DM, and to determine the state of glycemic control in children with DM2. Materials and methods. An analysis of glycemic control in children with DM2 who received various treatment regimens: with diet and lifestyle modifications, or with additional oral hypoglycemic agents (metformin monotherapy, or combination with insulin therapy). The glycemic control was assessed by measurement of glycated hemoglobin (HbA1c) level. Results. According to the data Register in Ukraine, the prevalence of DM among children has a tendency to rise — from 8.6 per 10 thousand children in 2005, to 13.14 — in 2019 year. The prevalence of DM2 in 2019 was 0.47 % of all cases of DM, and its prevalence contained 0.062 per 10 thousand children under 19 years of age with significant differences in the frequency of its diagnosis in different regions of Ukraine. We analyzed the state of glycemic control in children with DM2 aged from 9 up to 19 years old (Me 16.2 [15.5; 18.0]), with a  disease duration 0.5—12 years (Me 4.5 [1.0] ; 7.5]). The age of diagnosis of DM2 was 2-17 years old (Me 11.7 [8.5; 15.0]), and 91.3 % of patients had obesity. Diet and lifestyle modifications were used in 34.8 % of patients, metformin monotherapy in 52.2 %, and metformin and insulin combination therapy in 13 % of patients. HbA1c values ​​ranged from 5.0 to 11.4 % (Me 7.2 % [5,8; 8,0]). The proportion of children who had ideal or optimal glycemic control (HbA1c 7.0—7.5 %) was 52.2 %, suboptimal (HbA1c 7.6—9.0 %) — 39.1 %, high-risk glycemic control (HbA1c> 9.1 %) — 8.7 % of children. The most unsatisfactory HbA1c levels ​​were registered in children who received metformin in combination with insulin (Me 10.6 % [10,15; 11,4]). Chronic complications of DM2 have not been reported.Conclusions. We found a low prevalence of DM2 among the pediatric population in Ukraine, more likely due to the low quality of its detection among children diagnosed with DM, as well as among children among high risk groups. Most children with DM 2 were obese. The majority of patients with DM2 (52.2 %) received metformin monotherapy, more than a third did not receive oral hypoglycemic agents. In most children with DM2 (52,2 %), the state of glycemic control corresponded to the optimal (< 7.5 %), but higher levels of HbA1c were found children who received metformin in combination with insulin.


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