Raman Shetty

Current status of management, control, complications and psychosocial aspects of patients with diabetes in India: Results from the DiabCare India 2011 Study

Objectives: DiabCare India 2011 was a cross-sectional study in patients with diabetes mellitus, undertaken to investigate the relationship between diabetes control, management and complications in a subset of urban Indian diabetes patients treated at referral diabetes care centres in India. Materials and Methods: This was a cross-sectional, multicentre (330 centres) survey in 6168 diabetes patients treated at general hospitals, diabetes clinics and referral clinics across India. Patient data, including medical and clinical examination reports during the past year were collected during their routine visit. The patients’ and physicians’ perceptions about diabetes management were recorded using a questionnaire. Results: A total of 6168 subjects with diabetes (95.8% type 2), mean age 51.9 ± 12.4 years and mean duration of diabetes, 6.9 ± 6.4 years were included. Mean HbA1c was 8.9 ± 2.1% and the mean fasting (FPG), post prandial (PPG) and random (RBG) plasma glucose levels were 148 ± 50 mg/dl 205 ± 66 mg/dl and 193 ± 68mg/dl respectively. Neuropathy was the most common complication (41.4%); other complications were: Foot (32.7%), eye (19.7%), cardiovascular (6.8%) and nephropathy (6.2%). The number of diabetic complications increased with mean duration of diabetes. Most (93.2%) of the patients were on oral anti-diabetic drugs (OADs) and 35.2% were on insulin (±OADs). More than 15% physicians felt that the greatest barrier to insulin therapy from patients perspective were pain and fear of using injectable modality; 5.2% felt that the greatest barrier to insulin therapy from physicians perspective was the treatment cost; 4.8% felt that the major barriers to achieve optimum diabetic care in practice was loss to follow-up followed by lack of counselling (3.9%) and treatment compliance (3.6%). Conclusion: DiabCare India 2011 has shown that type 2 diabetes sets in early in Indians and glycaemic control is often sub-optimal in these patients. These results indicate a need for more structured intervention at an early stage of the disease and need for increased awareness on benefits of good glycaemic control. It cannot be overemphasized that the status of diabetes care in India needs to be further improved. (ClinTrials.gov identifier: NCT01351922)

Improving management practices and clinical outcomes in type 2 diabetes study: Prevalence of complications in people with type 2 diabetes in India

Introduction: Diabetes is the fourth leading cause of disease-related death and almost 80% of diabetes-related deaths occur in developing countries. Optimal glycemic control, in particular HbA1c level less than 7% with effective management of dyslipidemia and hypertension can reduce development of diabetes-related complications. Delay in initiating/or optimizing appropriate anti-diabetic therapy including insulin could be a possible cause of the increase in complications. Method: Improving management practices and clinical outcomes in type 2 diabetes (IMPACT) was a prospective, open-label, 26-week, comparative, multi-center study to compare efficacy and safety of the Indian insulin guideline (IIG) group versus routine clinical practice (RCP) group in type 2 diabetes patients. A total of 20,653 subjects from 885 centers across India were enrolled. Results: A total of 4695 patients (22.7%) (IIG, 4113 [22.6%]; RCP, 582 [23.5%]) had macrovascular complications and 8640 patients (41.8%) (IIG, 7486 [41.2%]; RCP, 1154 [46.6%]) had microvascular complications. Of 4695 patients with macrovascular complications, 2850 patients (60.7%) had coronary heart disease followed by 1457 patients (31.0%) with peripheral vascular disease. Of all the microvascular complications recorded, 5627 patients (65.1%) had peripheral neuropathy followed by 3313 patients (38.3%) with retinopathy. Conclusion: The rates of complications were high in patients with type 2 diabetes at the time of being initiated on insulin therapy in India.

Physician perceptions and practices in management of diabetes in India: Results from the IMPROVE Control program.

Introduction: The impact of IMPROVE Control Training program was evaluated by a non-interventional study and validated by a physician perception questionnaire. From a survey on 1086 physicians providing diabetes care in India, we report their practices and perceptions about diabetes care and insulin therapy. Materials and Methods: The responses were collected using a questionnaire validated by the IMPROVE Control Steering Committee. Results: Majority [558 (51.4%)] of the physicians accepted the ADA defined HbA1c target of <7% as the standard for good glycemic control in their practice. However, 541 (49.8%) of the physicians agreed that only 20-40% of their patients were able to achieve this target. For patients who do not achieve the glycemic control with oral anti-diabetic drugs (OADs) within 6 months of initiation of therapy, initiation of an optimal insulin regimen was the preferred choice for 492 (45.3%) of the participating physicians. Premixed insulin was preferred for initiating insulin therapy in patients with type 2 diabetes, by 676 (62.2%) of the participants [as compared to basal by 375 (34.5%) participants]. Once daily premixed insulin, intensified to twice daily was preferred as most optimal insulin regimen for initiation and subsequent intensification of insulin therapy [487 (44.8%) participants]. Most of the participants preferred adopting a multi-targeted approach for treating diabetes, hypertension, and dyslipidemia. Conclusions: Physicians prefer treatment goals similar to those recommended in the current guidelines of the American Diabetes Association for managing their patients with diabetes. Premixed insulin is preferred for initiation and intensification of insulin therapy.

Clinical experience of switching from biphasic human insulin to biphasic insulin aspart 30 in Indian patients with type 2 diabetes in the A1chieve study.

Aim: The aim of the following study is to evaluate the safety and effectiveness of switching from biphasic human insulin (BHI) to biphasic insulin aspart 30 (BIAsp 30) in Indian patients with type 2 diabetes as a sub-analysis of the 24-week, non-interventional A1chieve study. Materials and Methods: Indian patients switching from BHI to BIAsp 30 based on the physicians’ decisions were included. The primary outcome was the incidence of serious adverse drug reactions (SADRs), including major hypoglycemic events; secondary outcomes included changes in hypoglycemia in the 4 weeks preceding baseline and week 24 and changes from baseline to week 24 in glycated hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), body weight and quality of life (QoL). Results: Overall, 1976 patients (mean ± standard deviation age, 55.1 ± 10.6 years and diabetes duration, 10.1 ± 5.3 years) on a mean pre-study BHI dose of 0.44 ± 0.18 U/kg were included. The mean BIAsp 30 dose was 0.43 ± 0.17 U/kg at baseline and 0.44 ± 0.17 U/kg at week 24. No SADRs were reported. The proportion of patients reporting overall hypoglycemic events reduced significantly from baseline to week 24 (15.0% vs. 2.9%, P < 0.0001). The mean HbA1c level improved significantly from 9.1 ± 1.4% at baseline to 7.5 ± 1.0% at week 24, along with improvements in FPG, post-breakfast PPPG and QoL (P < 0.001). The mean body weight decreased from 69.3 ± 10.8 kg at baseline to 69.1 ± 10.4 kg at week 24 (P = 0.003). Conclusion: Switching from BHI to BIAsp 30 therapy was well-tolerated and was associated with improved glycemic control.

Baseline results indicate poor glycemic control and delay in initiation and optimization of insulin therapy: results from the improving management practices and clinical outcomes in type 2 diabetes study.

Introduction: Improving management practices and clinical outcomes in type 2 diabetes (IMPACT), was a prospective, open-label, 26- week, comparative, multi-center study to compare efficacy and safety of the Indian insulin guideline (IIG) group versus routine clinical practice (RCP) group in patients with type 2 diabetes. Materials and Methods: A total of 20,653 patients from 885 centers across India were enrolled and treated with premixed insulin therapy as per IIG or routine care. Results: Most of the participating centers (81.7%) reported following a diabetes guideline in their practice routinely but only 20.4% targeted HbA1c <7%. Very few of the physicians (2.7%) reported that most of their patients (>75%) achieved an HbA1c <7%. Most of the physicians (39.8%) also agreed that only 10-25% of the patients agree to start insulin therapy at the first counseling. Mean duration of diabetes before initiating insulin in patients using oral anti-diabetic drugs (OADs) was 7 years, indicating a delay in initiating insulin therapy. The difference in mean daily dose of insulin at initiation vs. at 26 weeks was only 0.8 U (25.8 ± 11.3 at initiation compared to 26.6 ± 9.5, respectively, p = ns) suggesting lack of treatment optimization. Weekly titration till achieving HbA1c <7% was done in 51.1% of the patients and only 8.9% performed self-titration. Conclusion: Baseline glycemic control in these patients was poor and reflects a delay in initiating insulin therapy. Data also reflect a lack of optimization of insulin doses.

Clinical experience of switching from glargine or neutral protamine Hagedorn insulin to insulin detemir in type 2 diabetes: Observations from the Indian cohort in the A 1 chieve study

Aim: To explore the clinical safety and effectiveness of insulin detemir (IDet) in a subgroup of Indian patients with type 2 diabetes (T2D) switched from either insulin glargine (IGlar) or neutral protamine Hagedorn (NPH) insulin in the 24-week, non-interventional A1chieve study. Materials and Methods: Indian patients with T2D switching from pre-study IGlaror NPH insulin to IDet were included. Safety and effectiveness outcomes were evaluated by the physicians in local clinical settings. Results: A total of 102 patients switched from IGlar to IDet (GLA group) and 39 patients switched from NPH insulin to IDet (NEU group). At baseline, the mean glycated hemoglobin A1c (HbA1c) levels were 9.9 ± 1.8% in the GLA group and 9.1 ± 1.2% in the NEU group. No serious adverse drug reactions, serious adverse events, or major hypoglycemic events were reported in either group throughout the study. At baseline and Week 24, 11.8% and 7.5% of patients, respectively, reported overall hypoglycemic events in the GLA group. No hypoglycemic events were reported at Week 24 in the NEU group. At Week 24, the mean HbA1c levels were 7.6 ± 0.9% in the GLA group and 7.3 ± 0.7% in the NEU group. The mean fasting plasma glucose, postprandial plasma glucose and quality of life also appeared to improve over 24 weeks. Conclusion: Switching to IDet therapy from IGlar and NPH insulin was well-tolerated and appeared to be associated with improved glycogenic control in Indian patients.

Baseline characteristics of the IMPROVE control study population: A study to evaluate the effectiveness of a standardized healthcare professionals training program

Introduction: The IMPROVE Control Training program was designed by Indian Academy of Diabetes (IAD), and a non-intervention study was conducted to evaluate the effectiveness of this standardized healthcare professionals (HCPs) training program on achieving treatment goals in patients with diabetes mellitus and its impact on standard of care. Materials and Methods: This multi-center, parallel group, open-label, non-randomized, non-intervention study included patients with type 2 diabetes who had an HbA1c >9 at time of diagnosis or an HbA1c >7% even after 6 months of initiation of therapy with anti-diabetic agents (Oral anti diabetic agents (OADs) and/or insulin). The data recorded at baseline included demographic characteristics, medical history, and the treatment regimens. Results: The study included 20,493 patients with diabetes, of which 13,295 (64.9%) were men. The mean [standard deviation (SD)] duration of diabetes was 6.4 (4.2) years and 6608 (32.2%) reported complications of diabetes. Poor glycemic control [HbA1c = 9.4 (1.3), FPG (mg/dl) = 181.2 (45.7); mean (SD)] was observed. The postprandial glucose was also high [post-breakfast, lunch, and dinner values in mg/dl were 263.6 (68.5), 278.1 (69.6), and 250.2 (63.7), respectively] in these patients. Failure of OADs was the most common reason cited for initiation of insulin. Premixed insulin was rated the regimen of choice for initiating therapy by the physicians (62.2% vs. 34.5% who preferred basal insulin). Conclusion: The baseline results confirm the poor glycemic control and the delayed initiation and/or inadequacy of treatment in subjects with type 2 diabetes. These results also highlight the need for early and optimal insulin-based therapy.

Liraglutide effect and action in diabetes-In (LEAD-In): A prospective observational study assessing safety and effectiveness of liraglutide in patients with type 2 diabetes mellitus treated under routine clinical practice conditions in India.

Background: This 26-week, open-label observational study assessed the incidence and type of adverse events (AEs) associated with liraglutide use according to the standard clinical practice settings and the local label in India. Materials and Methods: A total of 1416 adults with type 2 diabetes (T2D) treated with liraglutide in 125 sites across India were included in the study. Participants were newly diagnosed or already receiving antidiabetic medications. Safety and efficacy data were collected at baseline and at approximately weeks 13 and 26. The primary outcome was incidence and type of AEs while using liraglutide, with events classified by Medical Dictionary for Regulatory Activities system organ class and preferred term. The secondary objective was to assess other clinical parameters related to effective T2D management. Results: Twenty AEs, predominately gastrointestinal, were reported in 1.3% of the study population in scheduled visits up to week 26. No serious AEs, including death, were reported. Hypoglycemic episodes were reported in 7.3% of participants at baseline and 0.7% at week 26. No major hypoglycemic events were reported up to week 26 (baseline: 0.4%). Glycated hemoglobin was reduced from baseline (8.8 ± 1.3%) to week 26 by 1.6 ± 1.1% (P < 0.0001); significant improvements in fasting blood glucose, and 2-h postprandial blood glucose (post-breakfast, -lunch, and -dinner) were also observed. Mean body weight decreased by 8.1 ± 6.5 kg from baseline (92.5 ± 14.6 kg; P < 0.0001). Conclusions: From the number of AEs reported, it is suggested that liraglutide was well tolerated in subjects with T2D treated under standard clinical practice conditions in India. Liraglutide was effective, and no new safety concerns were identified.

Switching from basal or basal-bolus insulin to biphasic insulin aspart 30: Results from the Indian cohort of the A 1 chieve study

Aim: To determine the safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) therapy in the Indian patients with type 2 diabetes previously on basal or basal-bolus insulin therapies. Materials and Methods: Patients switching from insulin glargine, neutral protamine Hagedorn (NPH) insulin, or basal-bolus insulin to BIAsp 30 in the Indian cohort of the A1 chieve study were included. Safety and efficacy of treatment was evaluated over 24 weeks. Results: A total of 422 patients (pre-study basal-bolus insulin, 49; NPH insulin, 157; insulin glargine, 216) switched to BIAsp 30. Pre-study insulin doses were 0.61 ± 0.26 U/kg, 0.34 ± 0.2 U/kg and 0.40 ± 0.21 U/kg and the mean week 24 BIAsp 30 doses were 0.50 ± 0.21 U/kg, 0.35 ± 0.15 U/kg and 0.42 ± 0.16 U/kg in the prior basal-bolus insulin, NPH insulin and insulin glargine groups, respectively. No serious adverse drug reactions, major or nocturnal hypoglycemia were reported. The proportion of patients experiencing overall hypoglycemia was significantly lower from baseline (5.6%) to week 24 (1.0%) in the pre-study insulin-glargine group and appeared to be lower in pre-study NPH insulin and basal-bolus insulin groups. Glycemic control improved significantly from baseline week 24 in the pre-study NPH insulin and insulin-glargine groups (P < 0.001), while it appeared to improve in the pre-study basal-bolus group. Quality of life was positively impacted after 24 weeks in all 3 groups. Conclusion: The switch from basal or basal-bolus insulin to BIAsp 30 was safe, well tolerated and improved the glycemic control in this Indian cohort.

Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the North India cohort of the A 1 chieve study

Background: The A1chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66,726) in routine clinical care across four continents. Materials and Methods: Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from West India. Results: A total of 4192 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Patients had started on or were switched to biphasic insulin aspart (n = 2846), insulin detemir (n = 596), insulin aspart (n = 517), basal insulin plus insulin aspart (n = 140) and other insulin combinations (n = 83). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 8.8%) and insulin user (mean HbA1c: 9.1%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA1c (insulin naïve: −1.6%, insulin users: −1.7%). SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients. Conclusion: Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia.