A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec when Switching from Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults with Type 2 Diabetes

开始日期2024-06-20

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Novo Nordisk India Pvt Ltd.

CTRI/2023/07/055739 / Not yet recruiting临床3期

The cardiovascular safety of cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) once-weekly in participants with established cardiovascular disease - REDEFINE3

开始日期2023-09-28

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Novo Nordisk India Pvt Ltd.

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2021-11-01·Indian Journal of Dermatology4区 · 医学

Unearthing the Capital Choice in Chronic Idiopathic Urticaria (CIU) – A Randomized Controlled Trial

4区 · 医学

ArticleOA

作者: James, Jerin ; Varadarajan, Sathyanarayanan ; Ansari, Sanofer ; Fayaz, Syed H

Background:Chronic Idiopathic Urticaria (CIU) is a debilitating disease characterised by almost daily presence of urticarial symptoms like short-lived wheals, itching, and erythema for at least 6 weeks without an identifiable cause there by leading to impairment of quality of life of the patient.Aim:To evaluate the efficacy and safety of loratadine and rupatadine in chronic idiopathic urticaria.Methods:This is a prospective, randomized, single-blind, parallel arm study conducted to evaluate the efficacy and safety of loratadine and rupatadine in patients with CIU. The study was registered prospectively with Clinical Trial registry of India (CTRI/2017/05/008624). Institutional Ethics Committee clearance was obtained. Written informed consent was obtained from all the participants before enrolment into the trial. The study was conducted in the outpatient department of Dermatology, SRM Medical College, Kattankulathur, Tamil Nadu, India, during the period from June 2017 to August 2018. Patients with CIU enrolled into the study based on inclusion-exclusion criteria were given the intervention drugs; Loratadine 10 mg once daily or rupatadine10 mg once daily orally for 6 weeks.Results:Rupatadine is more efficacious than loratadine in the reduction of Total Leucocyte Count, Differential Count and Absolute Eosinophil Count, the key determinants of allergy. Rupatadine also produced better improvement in Total symptom Score, Dermatology Life Quality Index in patients with CIU.Conclusion:Analysis of all the parameters of efficacy and safety establishes the probable superiority of rupatadine over loratadine for the treatment of urticaria.

2014-01-01·Indian Journal of Endocrinology and Metabolism

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

Article

作者: Das, Ashok Kumar ; Sahay, Binode Kumar ; Kalra, Sanjay ; Rao, P V ; Wangnoo, Subhash Kumar ; Joshi, Shashank R ; Shah, Siddharth N ; Shetty, Raman V ; Sharma, Surendra Kumar ; Seshiah, V ; Banerjee, Samar ; Akhtar, Shahid ; Kumar, Ajay ; Unnikrishnan, A G ; Mohan, Viswanathan

OBJECTIVESDiabCare 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 METHODSThis 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.RESULTSA 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 patient's perspective were pain and fear of using injectable modality; 5.2% felt that the greatest barrier to insulin therapy from physician's 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%).CONCLUSIONDiabCare 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).

2013-01-01·Indian Journal of Endocrinology and Metabolism

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

Article

作者: Sen, Ranjini ; Singh, Awadhesh Kumar ; Gangopadhyay, Kalyan Kumar ; Majumdar, Sujoy ; Shetty, Raman ; Majumder, Anirban

BACKGROUNDThe 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 METHODSData was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from Kolkata, India.RESULTSA total of 576 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 = 417), insulin detemir (n = 70), insulin aspart (n = 55), basal insulin plus insulin aspart (n = 19) and other insulin combinations (n = 15). At baseline, glycaemic control was poor for both insulin naïve (mean HbA1c: 8.3%) and insulin user (mean HbA1c: 8.6%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA1c (insulin naïve: -1.3%, insulin users: -1.4%). SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients.CONCLUSIONStarting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia.

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