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 |
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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. |
doi_str_mv | 10.1007/s12325-009-0006-9 |
format | Article |
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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. These results also highlight the need for timely and appropriately intensive insulin-based therapy.</description><subject>Aged</subject><subject>Biphasic Insulins</subject><subject>Blood Glucose - drug effects</subject><subject>Body Mass Index</subject><subject>Cardiology</subject><subject>Cohort Studies</subject><subject>Demography</subject><subject>Diabetes Mellitus, Type 2 - complications</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetic Angiopathies - prevention & control</subject><subject>Endocrinology</subject><subject>Female</subject><subject>Glycated Hemoglobin A - drug effects</subject><subject>Health technology assessment</subject><subject>Humans</subject><subject>Hypoglycemia - chemically induced</subject><subject>Hypoglycemia - prevention & control</subject><subject>Hypoglycemic Agents - administration & dosage</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>India</subject><subject>Insulin - administration & dosage</subject><subject>Insulin - adverse effects</subject><subject>Insulin - analogs & derivatives</subject><subject>Insulin - therapeutic use</subject><subject>Insulin Aspart</subject><subject>Insulin, Isophane</subject><subject>Internal Medicine</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Oncology</subject><subject>Original Research</subject><subject>Patient Satisfaction</subject><subject>Pharmacology/Toxicology</subject><subject>Rheumatology</subject><issn>0741-238X</issn><issn>1865-8652</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc2KFTEQhYMoznX0AdxIdm5szU__JO50GHVgZERU3IV0utqboTtpU2nh7n0Sd76WT2IufcGdi0pRyalzIB8hjzl7zhnrXiAXUjQVY7oUayt9h-y4apuqlLhLdqyreSWk-npGHiDeMiZY16j75Ixr0Qgl1I78fm0RJh-Aur1N1mVIHrN3SONI8x7oVRi8DdTFfUyZjinO2_X7Dx9vvlz--fmLYl6Hw0tq6bxO2QebfQx2ekZjj5B-nMZNdTTt_bK36B31AdeSTC0utlhLRnMCm2cIJScmmg8LUEFLfA8Z8CG5N9oJ4dGpn5PPby4_Xbyrrm_eXl28uq6crGWuNG9bZYWuh1ZrphrX69ZyWTNlnet5P8DQMMVGaOpWlt7Xzo6d40pzcN3A5Tl5uvkuKX5fAbOZPTqYJhsgrmg6KaVoy1GUfFO6FBETjGZJfrbpYDgzR0BmA2QKIHMEZHTZeXJyX_sZhn8bJyJFIDYBlqfwDZK5jWsqP4j_cf0Ls6WfDg</recordid><startdate>20090301</startdate><enddate>20090301</enddate><creator>Shah, Siddharth</creator><creator>Das, A. K.</creator><creator>Kumar, Ajay</creator><creator>Unnikrishnan, A. G.</creator><creator>Kalra, Sanjay</creator><creator>Baruah, M. P.</creator><creator>Ganapathi, B.</creator><creator>Sahay, R. K.</creator><general>Springer Healthcare Communications</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20090301</creationdate><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><author>Shah, Siddharth ; Das, A. K. ; Kumar, Ajay ; Unnikrishnan, A. G. ; Kalra, Sanjay ; Baruah, M. P. ; Ganapathi, B. ; Sahay, R. K.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c343t-91668a294d699085cb96a13408accb1bded5080fe546380fb4caf7c1891ec7d13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Aged</topic><topic>Biphasic Insulins</topic><topic>Blood Glucose - drug effects</topic><topic>Body Mass Index</topic><topic>Cardiology</topic><topic>Cohort Studies</topic><topic>Demography</topic><topic>Diabetes Mellitus, Type 2 - complications</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetic Angiopathies - prevention & control</topic><topic>Endocrinology</topic><topic>Female</topic><topic>Glycated Hemoglobin A - drug effects</topic><topic>Health technology assessment</topic><topic>Humans</topic><topic>Hypoglycemia - chemically induced</topic><topic>Hypoglycemia - prevention & control</topic><topic>Hypoglycemic Agents - administration & dosage</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>India</topic><topic>Insulin - administration & dosage</topic><topic>Insulin - adverse effects</topic><topic>Insulin - analogs & derivatives</topic><topic>Insulin - therapeutic use</topic><topic>Insulin Aspart</topic><topic>Insulin, Isophane</topic><topic>Internal Medicine</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Oncology</topic><topic>Original Research</topic><topic>Patient Satisfaction</topic><topic>Pharmacology/Toxicology</topic><topic>Rheumatology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><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><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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