Usage of Glimepiride/Metformin Fixed-dose Combination in Young Individuals with Type 2 Diabetes: The Indian Experience

Background: The prevalence of diabetes has been rising among the younger population and is a cause for concern. The present case-based questionnaire survey evaluated the treatment pattern and clinical experience of healthcare professionals (HCPs) in prescribing glimepiride/metformin fixed-dose combination (FDC) to young diabetes patients (up to 40 years of age) in the Indian setting. Material and methods: A retrospective, multicenter, observational, questionnaire-based survey was conducted in Indian healthcare centers using medical records of patients having type 2 diabetes mellitus (T2DM), who were prescribed different strengths of glimepiride/metformin FDCs. Data was collected from the patients’ medical records and were analyzed using statistical tests. Results: A total of 2,715 patients aged between 18 and 40 years were included in the study. Mean diabetes duration among the young patients was 2.76 ± 1.97 years. Among the young T2DM patients, 83.2% patients received glimepiride/metformin FDC as first-line therapy, and 16.8% received it as second-line therapy. Hypoglycemia at 6 months was noted in only 2.47% of the young patients. Mean glycated hemoglobin (HbA1c) before and after treatment was 8.7% ± 3.4% and 7.3% ± 3.9%, respectively. Mean fasting plasma glucose (FPG) was 171.8 ± 80.1 mg/dL in patients prior to treatment initiation and came down to 122.8 ± 41.8 mg/dL after treatment with glimepiride/metformin FDC. Mean postprandial plasma glucose (PPG) prior to combination therapy use was 248.7 ± 64.0 mg/dL and dropped to 177.2 ± 39.9 mg/dL after treatment. Good to excellent efficacy and tolerability were reported for 86% and 86.6% patients, respectively. Conclusion: This case-based questionnaire survey demonstrates the usage pattern of various strengths of glimepiride/metformin FDCs and the HCPs’ practice approach regarding the use of this combination in young T2DM patients in the Indian setting. The combination is commonly prescribed to young diabetes patients in India and is associated with beneficial effects on glycemic parameters

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 A 1 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 Effectiveness and Impact on Insulin Therapy Cost After Addition of Dapagliflozin to Patients with Uncontrolled Type 2 Diabetes

<p><strong>Article full text</strong></p> <p><br> The full text of this article can be found <a href="https://link.springer.com/article/10.1007/s13300-016-0204-9"><b>here</b>.</a><br> <br> <strong>Provide enhanced digital features for this article</strong><br> If you are an author of this publication and would like to provide additional enhanced digital features for your article then please contact <u>[email protected]</u>.<br> <br> The journal offers a range of additional features designed to increase visibility and readership. All features will be thoroughly peer reviewed to ensure the content is of the highest scientific standard and all features are marked as ‘peer reviewed’ to ensure readers are aware that the content has been reviewed to the same level as the articles they are being presented alongside. Moreover, all sponsorship and disclosure information is included to provide complete transparency and adherence to good publication practices. This ensures that however the content is reached the reader has a full understanding of its origin. No fees are charged for hosting additional open access content.<br> <br> Other enhanced features include, but are not limited to:<br> • Slide decks<br> • Videos and animations<br> • Audio abstracts<br> • Audio slides<u></u></p

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

Importance of achieving the composite endpoints in diabetes

Well-conducted randomized controlled trials are instrumental in providing vital data on safety and efficacy of new molecules under consideration for approval. However acquiring such data involves huge cost and focused scientific endeavor. Selection and reporting of endpoints of a therapy is essential to assess the effect(s) of an intervention on overall disease control and guidelines have suggested the use of composite endpoint (CEP) in clinical trial design over individual endpoints to demonstrate the compound effect. Composite endpoints have been preferred for their ability to assess the net clinical benefit of an intervention, avoid misinterpretation associated with competing risks, avoid the challenge of using a single outcome to validate the study objectives and reduce the sample size requirements in trials on patients treated for diabetes. Concerns for misinterpretation or difficulty in interpretation of trial results involving CEPs arise when differences in the components with respect to either clinical importance or event rates, or magnitude of treatment effect exist and when there′s a possibility of biases due to competing risk. Suggestions for construction of composite endpoints and reporting the results of trials involving CEPs have been presented to improve the interpretations of overall effect of new interventions