Diabetes Care and Research Center

Bīkāner, India

Diabetes Care and Research Center

Bīkāner, India
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Russell-Jones D.,University of Surrey | Cuddihy R.M.,International Diabetes Center | Hanefeld M.,TU Dresden | Kumar A.,Diabetes Care and Research Center | And 4 more authors.
Diabetes Care | Year: 2012

OBJECTIVE - To test the safety and efficacy of exenatide once weekly (EQW) compared with metformin (MET), pioglitazone (PIO), and sitagliptin (SITA) over 26 weeks, in suboptimally treated (diet and exercise) drug-naive patients with type 2 diabetes. RESEARCH DESIGN AND METHODS - Patients were randomized to subcutaneous (SC) EQW 2.0 mg + oral placebo (n = 248), MET 2,000 mg/day + SC placebo (n = 246), PIO45 mg/day + SC placebo (n = 163), or SITA 100 mg/day + SC placebo (n = 163) for 26 weeks. MET and PIO therapies were increased to maximum-tolerated dosages. Injections with EQW or placebo were administered weekly, while oral medication or placebo was administered daily. RESULTS - Baseline characteristics were as follows: 59% men, 67% Caucasian, mean age 54 years, HbA1c 8.5%, fasting serum glucose 9.9 mmol/L, body weight 87.0 kg, and diabetes duration 2.7 years. HbA 1c reductions (%) at 26 weeks (least-squares means) with EQW versus MET, PIO, and SITA were -1.53 vs. -1.48 (P = 0.620), -1.63 (P = 0.328), and -1.15 (P < 0.001), respectively. Weight changes (kg) were -2.0 vs. -2.0 (P = 0.892), +1.5 (P < 0.001), and -0.8 (P < 0.001), respectively. Common adverse events were as follows: EQW, nausea (11.3%) and diarrhea (10.9%); MET, diarrhea (12.6%) and headache (12.2%); PIO, nasopharyngitis (8.6%) and headache (8.0%); and SIT, nasopharyngitis (9.8%) and headache (9.2%). Minor (confirmed) hypoglycemia was rarely reported. No major hypoglycemia occurred. CONCLUSIONS - EQW was noninferior to MET but not PIO and superior to SITA with regard to HbA1c reduction at 26 weeks. Of the agents studied, EQW and MET provided similar improvements in glycemic control along with the benefit of weight reduction and no increased risk of hypoglycemia. © 2012 by the American Diabetes Association.


Christiansen J.S.,University of Aarhus | Home P.,Northumbria University | Kumar A.,Diabetes Care and Research Center
Expert Review of Endocrinology and Metabolism | Year: 2016

SUMMARYThe co-formulation insulin degludec/insulin aspart (IDegAsp) contains insulin degludec (IDeg), a basal insulin, and the rapid-acting insulin aspart (IAsp). Its unique pharmacodynamic profile provides a stable basal insulin action over a 24-h period due to the flat, ultra-long effect of IDeg, combined with prandial control from IAsp, which is unaffected by the basal component. IDegAsp provides a distinct mealtime insulin peak effect and reduces the likelihood of postprandial glucose excursions. The phase 2 and 3 clinical trial program demonstrates that IDegAsp provides effective glycemic control with lower rates of hypoglycemia compared with the current standard of care for insulins. Compared with premixed insulin formulations, IDegAsp allows mealtime flexibility, enabling the time of injection to be adjusted to a different meal(s) on a daily basis to suit changing needs, and has the potential to improve adherence rates. IDegAsp offers a promising new insulin strategy for the treatment of type 2 diabetes. © 2016 Taylor & Francis.


Kumar A.,Diabetes Care and Research Center | Sharma S.K.,MG Medical College | Rajput R.,PGIMS | Unnikrishnan A.G.,Amrita Institute of Medical science
Journal of Association of Physicians of India | Year: 2013

Biphasic insulin aspart 30 (BIAsp 30) has been used in patients for almost a decade; There is a wealth of knowledge from clinical trials to document its efficacy and safety and suggest that BIAsp 30 is an option for initiation and intensification of insulin therapy in patients with type 2 diabetes mellitus (T2DM). The A1chieve® was a non-interventional study that explored the safety and effectiveness of initiating or switching to insulin analogues in routine clinical practice in more than 60,000 patients from 28 different countries. In this manuscript, we discuss the findings from the subgroup of the Indian cohort who were treated with BIAsp 30. In a cohort of 15287 who were on BIAsp 30, 12645 (83%) were insulin naïve and 2642 (17%) had been on insulin therapy earlier. Glycaemic parameters were high at baseline. Mean (SD) HbA1c was 9.2% (1.3) in the these and was comparable in the insulin naïve and insulin experienced groups. After 24 weeks of therapy with BIAsp 30, there were reductions in HbA1c in both the insulin naïve group, [-1.8 (1.3)] and insulin experienced group [-1.6 (1.3)]. Fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) levels were also reduced significantly from baseline [-3.4 (2.7) and -4.8 (3.8) mmol/L, respectively, p< 0.05). Overall, hypoglycaemia decreased from 1.33 events/ patient years at baseline to 0.19 events/ patient years at 24 weeks. There was also an increase in quality of life score as evaluated by EQ-5D questionnaire. Initiating insulin therapy with or switching to BIAsp 30 in patients with poor glycaemic control leads to an improvement in glycaemic profile with no major hypoglycaemia or clinically significant weight gain. Therapy with BIAsp 30 also improves the quality of life in patients with type 2 diabetes. © SUPPLEMENT TO JAPI.


Yang W.,China Japan Friendship Hospital | Chen L.,Wuhan Union Hospital | Ji Q.,Xijing University | Liu X.,Harbin Medical University | And 8 more authors.
Diabetes, Obesity and Metabolism | Year: 2011

Aim: To assess and compare the efficacy and safety of liraglutide with those of glimepiride, both in combination with metformin for the treatment of type 2 diabetes in Asian population from China, South Korea and India. Methods: A 16-week, randomized, double-blind, double-dummy, four-arm, active control trial was carried out. In total, 929 subjects with type 2 diabetes with a mean (±s.d.) age of 53.3 ± 9.5 years, HbA1c of 8.6 ± 1.0% and body weight of 68.1 ± 11.7 kg were randomized (liraglutide 0.6, 1.2 or 1.8 mg once daily or glimepiride 4 mg once daily all in combination with metformin: 1 1 1 1). One subject withdrew immediately after randomization and before exposure. Results: HbA1c was significantly reduced in all groups compared with baseline. Treatment with liraglutide 1.2 and 1.8 mg was non-inferior to glimepiride (mean HbA1c reduction: 1.36% points, 1.45% points and 1.39% points, respectively). No significant difference was shown in the percentage of subjects reaching American Diabetes Association HbA1c target <7% or American Association of Clinical Endocrinologists target ≤6.5% between liraglutide 1.2 and 1.8 mg and glimepiride. Liraglutide was associated with a 1.8-2.4 kg mean weight reduction, compared with a 0.1 kg mean weight gain with glimepiride. Liraglutide led to a significantly greater reduction in systolic blood pressure (SBP) compared with glimepiride. Two subjects in the glimepiride group reported major hypoglycaemia while none in the liraglutide groups. Liraglutide was associated with about 10-fold lower incidence of minor hypoglycaemia than glimepiride. Gastrointestinal disorders were the most common adverse events (AEs) for liraglutide, but were transient and resulted in few withdrawals. Conclusions: In Asian subjects with type 2 diabetes, once-daily liraglutide led to improvement in glycaemic control similar to that with glimepiride but with less frequent major and minor hypoglycaemia. Liraglutide also induced a significant weight loss and reduced SBP and was generally well tolerated. The most frequently reported AE was transient nausea. The effect of liraglutide in this Asian population is comparable to the effects seen in Caucasian, African American and Hispanic populations in global liraglutide phase 3 trials. © 2010 Blackwell Publishing Ltd.


Kumar A.,Diabetes Care and Research Center | Kalra S.,Bharti Hospital
Journal of Association of Physicians of India | Year: 2011

Tight glycemic control is central to reducing the risk of long-term macrovascular and microvascular complications of type 2 diabetes and the associated morbidity and mortality. However majority of the patients do not achieve glycemic targets (HbA1c < 7%). Once insulin treatment has been initiated, each patient's regimen must be optimized and intensified to reach the target. In many guidelines, initial insulin therapy comprises a single dose of long-acting insulin or premixed insulin. Basal insulin will help to control fasting plasma glucose (FPG) level, but postprandial glucose excursions make a significant contribution to the overall daily hyperglycemia of type 2 diabetic patients. BIAsp 30 is the most prescribed analog premix and consequently has the largest evidence base in terms of randomized controlled trials (RCTs) and observational data. It follows that BIAsp 30 is therefore the analog premix most likely to be used for insulin intensification, both from basal insulin and from BIAsp 30 regimens: OD to BID and from BID to TID. © SUPPLEMENT TO JAPI.


Kumar A.,Diabetes Care and Research Center
Indian Journal of Endocrinology and Metabolism | Year: 2016

Type 2 diabetes (T2D) represents an escalating burden worldwide, particularly in China and India. Compared with Caucasians, Asian people with diabetes have lower body mass index, increased visceral adiposity, and postprandial glucose (PPG)/insulin resistance. Since postprandial hyperglycemia contributes significantly to total glycemic burden and is associated with heightened cardiovascular risk, targeting PPG early in T2D is paramount. Premixed insulin regimens are widely used in Asia due to their convenience and effectiveness. Data from randomized controlled trials and observational studies comparing efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) with biphasic insulin lispro mix (LM 25/50) and versus other insulin therapies or oral antidiabetic drugs (OADs) in T2D demonstrated that BIAsp 30 and LM 25/50 were associated with similar or greater improvements in glycemic control versus comparator regimens, such as basal-bolus insulin, in insulin-naÏve, and prior insulin users. Studies directly comparing BIAsp 30 and LM 25 provided conflicting glycemic control results. Safety data generally showed increased hypoglycemia and weight gain with premixed insulins versus basal-bolus insulin or OADs. However, large observational trials documented improvements in glycated hemoglobin, PPG, and hypoglycemia with BIAsp 30 in multi-ethnic patient populations. In summary, this literature review demonstrates that premixed insulin regimens are an appropriate and effective treatment choice in T2D.


Agrawal R.P.,Diabetes Care and Research Center | Jain S.,Diabetes Care and Research Center | Shah S.,Diabetes Care and Research Center | Chopra A.,Diabetes Care and Research Center | Agarwal V.,Diabetes Care and Research Center
European Journal of Clinical Nutrition | Year: 2011

Background/Objectives: Hypoglycemic effect of camel milk supplementation in experimental rat model and significant reduction in doses of insulin in type 1 diabetic patients have been observed in our previous studies. This long-term study was undertaken to assess the efficacy, safety and acceptability of camel milk as an adjunct to insulin therapy in type 1 diabetics. Subjects/Methods: In this 2-year randomized clinical, parallel design study, 24 type 1 diabetics were enrolled and divided into two groups. Group I (n=12) received usual care, that is, diet, exercise and insulin and Group II (n=12) received 500 ml camel milk in addition to the usual care. Insulin requirement was titrated weekly by blood glucose estimation. Results were analyzed by using the regression technique. Results: In camel milk group, there was decrease in mean blood glucose (118.58±19-93.16±17.06 mg/dl), hemoglobin A1c levels (7.81±1.39-5.44±0.81%) and insulin doses (32.50±9.99-17. 50±12.09 U/day, P<0.05). Out of 12 subjects receiving camel milk, insulin requirement in 3 subjects reduced to zero. There was nonsignificant change in plasma insulin and anti-insulin antibodies in both the groups. Conclusion: It may be stated that camel milk is safe and efficacious in improving long-term glycemic control, with a significant reduction in the doses of insulin in type 1 diabetic patients. © 2011 Macmillan Publishers Limited All rights reserved.


Kumar A.,Diabetes Care and Research Center
Diabetes/Metabolism Research and Reviews | Year: 2012

Following diagnosis, type 2 diabetic subjects are invariably treated with life style modifications and metformin. However, majority of these subjects require addition of another therapeutic agent singly or in combination; with or without insulin within few months to few years. For several decades, sulphonylureas and insulin have been the second line agent of choice. Clinical practice guidelines also suggest a similar approach. Subsequently thiazolidinediones, alpha glucose inhibitors and other agents were added to therapeutic armamentarium. Unfortunately, none of these treatment options could address the issue of progressive decline in beta cell function. Furthermore, they are responsible for unacceptable incidence of hypoglycaemia, weight gain and other side effects related to individual agents. Type 2 diabetic subjects have great propensity to develop cardiovascular complications. Sulphonylureas, insulin and thiazolidinediones have all been associated with adverse cardiovascular outcomes in differing magnitude. It has been made mandatory by regulatory agencies to ensure cardiovascular safety of any new anti-diabetic agent. Glucagon Like Peptide-1(GLP-1)-based therapies have been able to address several of these issues. Incretin mimetics and Di Peptidyl Dipeptidase IV (DPP-IV) inhibitors cause glucose-dependent insulin secretion and glucagon suppression from beta and alpha cells of the pancreas respectively. They owe this property to their binding with G-Protein-coupled receptors leading to an increased amount of c-AMP. They do not cause beta cell exhaustion. On the contrary such agents prevent beta cell apoptosis. Clinical trials have established the superiority of incretin mimetics particularly liraglutide against comparators including glimepiride, rosiglitazone and insulin Glargine in terms of efficacy. Furthermore, they have shown evidence towards beta cell protection, significant weight loss, minimal hypoglycaemia and favourable impact on surrogate markers of cardiovascular outcomes. DPP-IV inhibitors have limited ability to achieve glycaemic targets. However, they are weight neutral, cause minimal hypoglycaemia and have some beneficial effect on beta cell function. Finally, they are very well tolerated. © 2012 John Wiley & Sons, Ltd.


Kumar A.,Diabetes Care and Research Center
Expert Opinion on Biological Therapy | Year: 2014

Introduction: Existing pharmacological therapies with basal insulins are limited by weight gain and hypoglycemia, while those with glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) are limited by issues of efficacy when used alone. However, when used in combination they show a complementarity of action, in terms of reducing the incidence of hypoglycemia while providing sufficient glycemic control, that might help counterbalance their individual limitations. Clinical trials have demonstrated better efficacy and safety profile of this combination. Insulin degludec/liraglutide (IDegLira) is a once-daily fixed-dose combination of ultra-long-acting basal insulin degludec (IDeg) and GLP-1 RA, liraglutide. Areas covered: We reviewed published data regarding chemistry, pharmacokinetics, pharmacodynamics, clinical efficacy and safety of IDeg, liraglutide and the co-formulation. Literature was searched from the electronic medical database PubMed up to December 2013. Expert opinion: Preliminary studies on IDegLira indicate improved overall glycemic control, better safety profile with reduction in bodyweight and low rate of hypoglycemia compared to IDeg but higher rates of hypoglycemia than liraglutide therapy alone. Further, simplicity of fixed-dose combination offers an additional advantage of improved treatment adherence. IDegLira might be used similar to basal insulins in the current treatment algorithms, but with a greater preference for initiation instead of two or more oral drugs. © 2014 Informa UK, Ltd.


PubMed | Diabetes Care and Research Center
Type: Journal Article | Journal: Indian journal of endocrinology and metabolism | Year: 2016

Type 2 diabetes (T2D) represents an escalating burden worldwide, particularly in China and India. Compared with Caucasians, Asian people with diabetes have lower body mass index, increased visceral adiposity, and postprandial glucose (PPG)/insulin resistance. Since postprandial hyperglycemia contributes significantly to total glycemic burden and is associated with heightened cardiovascular risk, targeting PPG early in T2D is paramount. Premixed insulin regimens are widely used in Asia due to their convenience and effectiveness. Data from randomized controlled trials and observational studies comparing efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) with biphasic insulin lispro mix (LM 25/50) and versus other insulin therapies or oral antidiabetic drugs (OADs) in T2D demonstrated that BIAsp 30 and LM 25/50 were associated with similar or greater improvements in glycemic control versus comparator regimens, such as basal-bolus insulin, in insulin-nave, and prior insulin users. Studies directly comparing BIAsp 30 and LM 25 provided conflicting glycemic control results. Safety data generally showed increased hypoglycemia and weight gain with premixed insulins versus basal-bolus insulin or OADs. However, large observational trials documented improvements in glycated hemoglobin, PPG, and hypoglycemia with BIAsp 30 in multi-ethnic patient populations. In summary, this literature review demonstrates that premixed insulin regimens are an appropriate and effective treatment choice in T2D.

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