Document Detail

Baseline characteristics of the Indian cohort from the IMPROVE study: a multinational, observational study of biphasic insulin aspart 30 treatment for type 2 diabetes.
MedLine Citation:
PMID:  19252828     Owner:  NLM     Status:  MEDLINE    
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 [HbA(1c)], 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 HbA(1c) 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.
Siddharth Shah; A K Das; Ajay Kumar; A G Unnikrishnan; Sanjay Kalra; M P Baruah; B Ganapathi; R K Sahay
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2009-02-27
Journal Detail:
Title:  Advances in therapy     Volume:  26     ISSN:  1865-8652     ISO Abbreviation:  Adv Ther     Publication Date:  2009 Mar 
Date Detail:
Created Date:  2009-04-14     Completed Date:  2010-02-18     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8611864     Medline TA:  Adv Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  325-35     Citation Subset:  T    
Department of Endocrinology, S. L. Raheja Hospital, Mumbai, India.
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MeSH Terms
Blood Glucose / drug effects
Body Mass Index
Cohort Studies
Diabetes Mellitus, Type 2 / complications,  drug therapy*
Diabetic Angiopathies / prevention & control*
Hemoglobin A, Glycosylated / drug effects
Hypoglycemia / chemically induced,  prevention & control
Hypoglycemic Agents / administration & dosage,  adverse effects,  therapeutic use*
Insulin / administration & dosage,  adverse effects,  analogs & derivatives*,  therapeutic use
Middle Aged
Patient Satisfaction
Reg. No./Substance:
0/Blood Glucose; 0/Hemoglobin A, Glycosylated; 0/Hypoglycemic Agents; 0/insulin aspart; 11061-68-0/Insulin

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