Publication Type : Journal Article
Publisher : Advances in Therapy
Source : Advances in Therapy, Volume 26, Number 3, p.325-335 (2009)
Keywords : aged, article, autonomic neuropathy, Blood Glucose, Blood glucose monitoring, Body Mass Index, Clinical trial, cohort analysis, Cohort Studies, demography, diabetes mellitus, Diabetic Angiopathies, diabetic nephropathy, diabetic neuropathy, Diabetic Retinopathy, disease duration, drug efficacy, drug safety, female, glycemic control, Glycosylated, Hemoglobin A, hemoglobin A1c, hemoglobin blood level, human, Humans, hypoglycemia, Hypoglycemic Agents, India, Indian, insulin, insulin aspart, ischemic heart disease, major clinical study, male, microangiopathy, middle aged, multicenter study, non insulin dependent diabetes mellitus, novo mix, observational study, oral antidiabetic agent, patient satisfaction, peripheral neuropathy, peripheral vascular disease, Stroke, Type 2, unclassified drug
Year : 2009
Abstract : Introduction: The IMPROVE™ study is an openlabel, nonrandomized, observational study aimed at determining the safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) treatment in subjects with type 2 diabetes from 11 countries. Here, we report the baseline data of the Indian cohort. Methods: All subjects with type 2 diabetes requiring insulin and considered suitable for BIAsp 30 therapy based on their physician's clinical judgment were eligible to enter the study. The data recorded at baseline included demographic characteristics, detailed medical histories, physician-cited reasons for starting BIAsp 30 treatment, and the chosen dosage regimens. Results: The Indian cohort included 17,995 subjects with diabetes. Poor glycemic control (glycated hemoglobin [HbA1c], 8.7%-9.6%) was observed at baseline in all four geographical zones (North, South, East, and West) and prestudy treatment groups (no therapy, only oral antidiabetic drug [OAD], OAD ± insulin, and OAD ± insulin ± BIAsp 30). Prevalence of both micro- and macrovascular complications was high, also reflecting poor glycemic control. Improving HbA1c and fasting and postprandial blood glucose levels were the most common reasons for starting BIAsp 30 therapy. The subjects were prescribed a mean BIAsp 30 dose of approximately 24 IU, and a twice-daily regimen was employed in almost 80% of subjects. Conclusion: The baseline results of the IMPROVE study Indian cohort 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 timely and appropriately intensive insulin-based therapy. © 2009 Springer Healthcare Communications.
Cite this Research Publication : Sa Shah, Das, A. Kb, Kumar, Ac, Unnikrishnan, A. Gd, Kalra, Se, Baruah, M. Pf, Ganapathi, Bg, and Sahay, R. Kh, “Baseline characteristics of the Indian cohort from the IMPROVE™ study: A multinational, observational study of biphasic insulin aspart 30 treatment for type 2 diabetes”, Advances in Therapy, vol. 26, pp. 325-335, 2009.