Baseline characteristics of the Indian cohort from the IMPROVE™ study: a multinational, observational study of biphasic insulin aspart 30 treatment for type 2 diabetes

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...

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Veröffentlicht in:Advances in therapy 2009-03, Vol.26 (3), p.325-335
Hauptverfasser: Shah, Siddharth, Das, A. K., Kumar, Ajay, Unnikrishnan, A. G., Kalra, Sanjay, Baruah, M. P., Ganapathi, B., Sahay, R. K.
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container_end_page 335
container_issue 3
container_start_page 325
container_title Advances in therapy
container_volume 26
creator Shah, Siddharth
Das, A. K.
Kumar, Ajay
Unnikrishnan, A. G.
Kalra, Sanjay
Baruah, M. P.
Ganapathi, B.
Sahay, R. K.
description 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.
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K. ; Kumar, Ajay ; Unnikrishnan, A. G. ; Kalra, Sanjay ; Baruah, M. P. ; Ganapathi, B. ; Sahay, R. K.</creator><creatorcontrib>Shah, Siddharth ; Das, A. K. ; Kumar, Ajay ; Unnikrishnan, A. G. ; Kalra, Sanjay ; Baruah, M. P. ; Ganapathi, B. ; Sahay, R. K.</creatorcontrib><description>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.</description><identifier>ISSN: 0741-238X</identifier><identifier>EISSN: 1865-8652</identifier><identifier>DOI: 10.1007/s12325-009-0006-9</identifier><identifier>PMID: 19252828</identifier><language>eng</language><publisher>Heidelberg: Springer Healthcare Communications</publisher><subject><![CDATA[Aged ; Biphasic Insulins ; Blood Glucose - drug effects ; Body Mass Index ; Cardiology ; Cohort Studies ; Demography ; Diabetes Mellitus, Type 2 - complications ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetic Angiopathies - prevention & control ; Endocrinology ; Female ; Glycated Hemoglobin A - drug effects ; Health technology assessment ; Humans ; Hypoglycemia - chemically induced ; Hypoglycemia - prevention & control ; Hypoglycemic Agents - administration & dosage ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - therapeutic use ; India ; Insulin - administration & dosage ; Insulin - adverse effects ; Insulin - analogs & derivatives ; Insulin - therapeutic use ; Insulin Aspart ; Insulin, Isophane ; Internal Medicine ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Oncology ; Original Research ; Patient Satisfaction ; Pharmacology/Toxicology ; Rheumatology]]></subject><ispartof>Advances in therapy, 2009-03, Vol.26 (3), p.325-335</ispartof><rights>Springer Healthcare Communications 2009</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c343t-91668a294d699085cb96a13408accb1bded5080fe546380fb4caf7c1891ec7d13</citedby><cites>FETCH-LOGICAL-c343t-91668a294d699085cb96a13408accb1bded5080fe546380fb4caf7c1891ec7d13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12325-009-0006-9$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12325-009-0006-9$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19252828$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shah, Siddharth</creatorcontrib><creatorcontrib>Das, A. K.</creatorcontrib><creatorcontrib>Kumar, Ajay</creatorcontrib><creatorcontrib>Unnikrishnan, A. G.</creatorcontrib><creatorcontrib>Kalra, Sanjay</creatorcontrib><creatorcontrib>Baruah, M. P.</creatorcontrib><creatorcontrib>Ganapathi, B.</creatorcontrib><creatorcontrib>Sahay, R. K.</creatorcontrib><title>Baseline characteristics of the Indian cohort from the IMPROVE™ study: a multinational, observational study of biphasic insulin aspart 30 treatment for type 2 diabetes</title><title>Advances in therapy</title><addtitle>Adv Therapy</addtitle><addtitle>Adv Ther</addtitle><description>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. 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K.</creatorcontrib><creatorcontrib>Kumar, Ajay</creatorcontrib><creatorcontrib>Unnikrishnan, A. G.</creatorcontrib><creatorcontrib>Kalra, Sanjay</creatorcontrib><creatorcontrib>Baruah, M. P.</creatorcontrib><creatorcontrib>Ganapathi, B.</creatorcontrib><creatorcontrib>Sahay, R. K.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Advances in therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shah, Siddharth</au><au>Das, A. K.</au><au>Kumar, Ajay</au><au>Unnikrishnan, A. G.</au><au>Kalra, Sanjay</au><au>Baruah, M. P.</au><au>Ganapathi, B.</au><au>Sahay, R. K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Baseline characteristics of the Indian cohort from the IMPROVE™ study: a multinational, observational study of biphasic insulin aspart 30 treatment for type 2 diabetes</atitle><jtitle>Advances in therapy</jtitle><stitle>Adv Therapy</stitle><addtitle>Adv Ther</addtitle><date>2009-03-01</date><risdate>2009</risdate><volume>26</volume><issue>3</issue><spage>325</spage><epage>335</epage><pages>325-335</pages><issn>0741-238X</issn><eissn>1865-8652</eissn><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 [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.</abstract><cop>Heidelberg</cop><pub>Springer Healthcare Communications</pub><pmid>19252828</pmid><doi>10.1007/s12325-009-0006-9</doi><tpages>11</tpages></addata></record>
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subjects Aged
Biphasic Insulins
Blood Glucose - drug effects
Body Mass Index
Cardiology
Cohort Studies
Demography
Diabetes Mellitus, Type 2 - complications
Diabetes Mellitus, Type 2 - drug therapy
Diabetic Angiopathies - prevention & control
Endocrinology
Female
Glycated Hemoglobin A - drug effects
Health technology assessment
Humans
Hypoglycemia - chemically induced
Hypoglycemia - prevention & control
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - adverse effects
Hypoglycemic Agents - therapeutic use
India
Insulin - administration & dosage
Insulin - adverse effects
Insulin - analogs & derivatives
Insulin - therapeutic use
Insulin Aspart
Insulin, Isophane
Internal Medicine
Male
Medicine
Medicine & Public Health
Middle Aged
Oncology
Original Research
Patient Satisfaction
Pharmacology/Toxicology
Rheumatology
title Baseline characteristics of the Indian cohort from the IMPROVE™ study: a multinational, observational study of biphasic insulin aspart 30 treatment for type 2 diabetes
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