Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus
Objective: The goal of this study was to compare the efficacy and safety profiles of biphasic insulin aspart 30 (30% soluble insulin aspart and 70% protaminated insulin aspart [BIAsp 30]) and biphasic insulin lispro 25 (25% soluble insulin lispro and 75% neutral protamine lispro [Mix25]) used in a B...
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| Veröffentlicht in: | Clinical therapeutics 2004-04, Vol.26 (4), p.531-540 |
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| creator | Niskanen, Leo Jensen, Linda Elise Råstam, Jacob Nygaard-Pedersen, Lars Erichsen, Knut Vora, Jiten P |
| description | Objective: The goal of this study was to compare the efficacy and safety profiles of biphasic insulin aspart 30 (30% soluble insulin aspart and 70% protaminated insulin aspart [BIAsp 30]) and biphasic insulin lispro 25 (25% soluble insulin lispro and 75% neutral protamine lispro [Mix25]) used in a BID injection regimen in patients with type 2 diabetes mellitus (DM). Also assessed was patients' preference for pen device—the NovoMix® 30 FlexPen®/NovoLog® Mix 70/30 FlexPen® (FlexPen) versus the Humalog® Mix25
TM Pen/Humalog® Mix75/25
TM Pen (Humalog Pen).
Methods: Patients with type 2 DM receiving current insulin treatment were randomized to a multinational, multicenter, open-label, 2-period, crossover comparison of BIAsp 30 and Mix25. Efficacy (by analyses of variance) and safety profiles were assessed after 12 weeks of treatment. Patients' preference for pen device was assessed by questionnaires.
Results: A total of 137 patients were randomized to treatment; 4 were withdrawn during the 2-week run-in treatment with biphasic human insulin 30. The mean (SD) characteristics of the remaining 133 patients (79 men, 54 women) were as follows: age, 62.3 (9.2) years; body mass index, 28.1 (3.9) kg/m
2; and glycosylatd hemoglobin (HbA
1c), 8.5% (1.1). Glycemic control was assessed by the measurement of HbA
1c after 12 weeks of treatment. Treatment with BIAsp 30 was noninferior to treatment with Mix25 (upper limit of 90% CI for estimated difference [BIAsp 30 - Mix25] was |
| doi_str_mv | 10.1016/S0149-2918(04)90055-0 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_72004507</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0149291804900550</els_id><sourcerecordid>72004507</sourcerecordid><originalsourceid>FETCH-LOGICAL-c419t-57d6fc2fd12889ce73849423fadd6d2b43acdc8232c4110e20aa16f0c332bc9f3</originalsourceid><addsrcrecordid>eNqFkduK1jAUhYMozu_oIygBURSmupM0bXMlMniCAcEDeBfSZJfJ0DY1SX8ZH88nM_8BFb3wKoH9rb0XaxFyn8EzBqx5_hFYrSquWPcE6qcKQMoKbpAN61pVMVZ_uUk2v5ATcielKwAQSvLb5IRJ1qlWwob8-GBmFyb_Hd0ZndYx-9lkH2YzntGw4FyNpsfy59WC0YcC2RhSCluM1IZpMdGnMNMw0N4vlyZ5S_2c1tHP1KQyzVQALSf-HY8-LTFQLvfjcoo63HqLie60rlihS7GCc070m8-XNF8vSDl1vjjKBZtwHH1e011yazBjwnvH95R8fv3q0_nb6uL9m3fnLy8qWzOVK9m6ZrB8cIx3nbLYiq5WNReDca5xvK-Fsc52XPDCM0AOxrBmACsE760axCl5fNhbbH9dMWU9-WSLCTNjWJNuOUAtoS3gw7_Aq7DGEmnSDARXnCvBCyUP1D7QiINeop9MvC6Q3lWs9xXrXX8aar2vWEPRPThuX_sJ3W_VsdMCPDoCJlkzDtHM1qc_uLaBRsrCvThwWELbeow62RK3Recj2qxd8P-x8hOrMsWd</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1032922932</pqid></control><display><type>article</type><title>Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><source>ProQuest Central UK/Ireland</source><creator>Niskanen, Leo ; Jensen, Linda Elise ; Råstam, Jacob ; Nygaard-Pedersen, Lars ; Erichsen, Knut ; Vora, Jiten P</creator><creatorcontrib>Niskanen, Leo ; Jensen, Linda Elise ; Råstam, Jacob ; Nygaard-Pedersen, Lars ; Erichsen, Knut ; Vora, Jiten P</creatorcontrib><description>Objective: The goal of this study was to compare the efficacy and safety profiles of biphasic insulin aspart 30 (30% soluble insulin aspart and 70% protaminated insulin aspart [BIAsp 30]) and biphasic insulin lispro 25 (25% soluble insulin lispro and 75% neutral protamine lispro [Mix25]) used in a BID injection regimen in patients with type 2 diabetes mellitus (DM). Also assessed was patients' preference for pen device—the NovoMix® 30 FlexPen®/NovoLog® Mix 70/30 FlexPen® (FlexPen) versus the Humalog® Mix25
TM Pen/Humalog® Mix75/25
TM Pen (Humalog Pen).
Methods: Patients with type 2 DM receiving current insulin treatment were randomized to a multinational, multicenter, open-label, 2-period, crossover comparison of BIAsp 30 and Mix25. Efficacy (by analyses of variance) and safety profiles were assessed after 12 weeks of treatment. Patients' preference for pen device was assessed by questionnaires.
Results: A total of 137 patients were randomized to treatment; 4 were withdrawn during the 2-week run-in treatment with biphasic human insulin 30. The mean (SD) characteristics of the remaining 133 patients (79 men, 54 women) were as follows: age, 62.3 (9.2) years; body mass index, 28.1 (3.9) kg/m
2; and glycosylatd hemoglobin (HbA
1c), 8.5% (1.1). Glycemic control was assessed by the measurement of HbA
1c after 12 weeks of treatment. Treatment with BIAsp 30 was noninferior to treatment with Mix25 (upper limit of 90% CI for estimated difference [BIAsp 30 - Mix25] was <0.4%). Self-monitored blood glucose levels were comparable (
P = NS). Adverse-event profiles were similar between treatments, as was the incidence of hypoglycemic episodes (0.69 episode/mo with BIAsp 30 and 0.62 episode/mo with Mix25, P = 0.292). For all device features assessed, the FlexPen consistently received higher scores (all
P < 0.005). A total of 9.0% of patients experienced problems with the FlexPen, compared with 32.4% with the Humalog Pen (
P < 0.001). Furthermore, 74.6% preferred to continue using the FlexPen, whereas 14.3% preferred the Humalog Pen (
P < 0.001).
Conclusions: In this study, glycemic control with BIAsp 30 and Mix25 was found to be comparable in these patients with type 2 DM. Safety profiles were similar for both regimens. Patients preferred and experienced fewer problems with the FlexPen than the Humalog Pen.</description><identifier>ISSN: 0149-2918</identifier><identifier>EISSN: 1879-114X</identifier><identifier>DOI: 10.1016/S0149-2918(04)90055-0</identifier><identifier>PMID: 15189750</identifier><language>eng</language><publisher>Belle Mead, NJ: EM Inc USA</publisher><subject>Biological and medical sciences ; biphasic insulin ; Biphasic Insulins ; Blood Glucose - drug effects ; Cross-Over Studies ; Diabetes ; Diabetes Mellitus, Type 2 - drug therapy ; Disposable Equipment ; Female ; FlexPen ; Generalized linear models ; Glycemic Index - drug effects ; Humalog Pen ; Humans ; Hypoglycemic Agents - administration & dosage ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - therapeutic use ; Injections, Subcutaneous ; Insulin ; Insulin - administration & dosage ; Insulin - adverse effects ; Insulin - analogs & derivatives ; Insulin - therapeutic use ; insulin analog ; Insulin Aspart ; Insulin Lispro ; Insulin, Isophane ; Male ; Medical sciences ; Middle Aged ; Patient Satisfaction ; Patients ; pen device ; Pharmacology. Drug treatments ; Syringes ; Treatment Outcome</subject><ispartof>Clinical therapeutics, 2004-04, Vol.26 (4), p.531-540</ispartof><rights>2004</rights><rights>2004 INIST-CNRS</rights><rights>Copyright Elsevier Limited Apr 2004</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c419t-57d6fc2fd12889ce73849423fadd6d2b43acdc8232c4110e20aa16f0c332bc9f3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1032922932?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976,64364,64366,64368,72218</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15760655$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15189750$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Niskanen, Leo</creatorcontrib><creatorcontrib>Jensen, Linda Elise</creatorcontrib><creatorcontrib>Råstam, Jacob</creatorcontrib><creatorcontrib>Nygaard-Pedersen, Lars</creatorcontrib><creatorcontrib>Erichsen, Knut</creatorcontrib><creatorcontrib>Vora, Jiten P</creatorcontrib><title>Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus</title><title>Clinical therapeutics</title><addtitle>Clin Ther</addtitle><description>Objective: The goal of this study was to compare the efficacy and safety profiles of biphasic insulin aspart 30 (30% soluble insulin aspart and 70% protaminated insulin aspart [BIAsp 30]) and biphasic insulin lispro 25 (25% soluble insulin lispro and 75% neutral protamine lispro [Mix25]) used in a BID injection regimen in patients with type 2 diabetes mellitus (DM). Also assessed was patients' preference for pen device—the NovoMix® 30 FlexPen®/NovoLog® Mix 70/30 FlexPen® (FlexPen) versus the Humalog® Mix25
TM Pen/Humalog® Mix75/25
TM Pen (Humalog Pen).
Methods: Patients with type 2 DM receiving current insulin treatment were randomized to a multinational, multicenter, open-label, 2-period, crossover comparison of BIAsp 30 and Mix25. Efficacy (by analyses of variance) and safety profiles were assessed after 12 weeks of treatment. Patients' preference for pen device was assessed by questionnaires.
Results: A total of 137 patients were randomized to treatment; 4 were withdrawn during the 2-week run-in treatment with biphasic human insulin 30. The mean (SD) characteristics of the remaining 133 patients (79 men, 54 women) were as follows: age, 62.3 (9.2) years; body mass index, 28.1 (3.9) kg/m
2; and glycosylatd hemoglobin (HbA
1c), 8.5% (1.1). Glycemic control was assessed by the measurement of HbA
1c after 12 weeks of treatment. Treatment with BIAsp 30 was noninferior to treatment with Mix25 (upper limit of 90% CI for estimated difference [BIAsp 30 - Mix25] was <0.4%). Self-monitored blood glucose levels were comparable (
P = NS). Adverse-event profiles were similar between treatments, as was the incidence of hypoglycemic episodes (0.69 episode/mo with BIAsp 30 and 0.62 episode/mo with Mix25, P = 0.292). For all device features assessed, the FlexPen consistently received higher scores (all
P < 0.005). A total of 9.0% of patients experienced problems with the FlexPen, compared with 32.4% with the Humalog Pen (
P < 0.001). Furthermore, 74.6% preferred to continue using the FlexPen, whereas 14.3% preferred the Humalog Pen (
P < 0.001).
Conclusions: In this study, glycemic control with BIAsp 30 and Mix25 was found to be comparable in these patients with type 2 DM. Safety profiles were similar for both regimens. Patients preferred and experienced fewer problems with the FlexPen than the Humalog Pen.</description><subject>Biological and medical sciences</subject><subject>biphasic insulin</subject><subject>Biphasic Insulins</subject><subject>Blood Glucose - drug effects</subject><subject>Cross-Over Studies</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Disposable Equipment</subject><subject>Female</subject><subject>FlexPen</subject><subject>Generalized linear models</subject><subject>Glycemic Index - drug effects</subject><subject>Humalog Pen</subject><subject>Humans</subject><subject>Hypoglycemic Agents - administration & dosage</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Injections, Subcutaneous</subject><subject>Insulin</subject><subject>Insulin - administration & dosage</subject><subject>Insulin - adverse effects</subject><subject>Insulin - analogs & derivatives</subject><subject>Insulin - therapeutic use</subject><subject>insulin analog</subject><subject>Insulin Aspart</subject><subject>Insulin Lispro</subject><subject>Insulin, Isophane</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Patient Satisfaction</subject><subject>Patients</subject><subject>pen device</subject><subject>Pharmacology. Drug treatments</subject><subject>Syringes</subject><subject>Treatment Outcome</subject><issn>0149-2918</issn><issn>1879-114X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkduK1jAUhYMozu_oIygBURSmupM0bXMlMniCAcEDeBfSZJfJ0DY1SX8ZH88nM_8BFb3wKoH9rb0XaxFyn8EzBqx5_hFYrSquWPcE6qcKQMoKbpAN61pVMVZ_uUk2v5ATcielKwAQSvLb5IRJ1qlWwob8-GBmFyb_Hd0ZndYx-9lkH2YzntGw4FyNpsfy59WC0YcC2RhSCluM1IZpMdGnMNMw0N4vlyZ5S_2c1tHP1KQyzVQALSf-HY8-LTFQLvfjcoo63HqLie60rlihS7GCc070m8-XNF8vSDl1vjjKBZtwHH1e011yazBjwnvH95R8fv3q0_nb6uL9m3fnLy8qWzOVK9m6ZrB8cIx3nbLYiq5WNReDca5xvK-Fsc52XPDCM0AOxrBmACsE760axCl5fNhbbH9dMWU9-WSLCTNjWJNuOUAtoS3gw7_Aq7DGEmnSDARXnCvBCyUP1D7QiINeop9MvC6Q3lWs9xXrXX8aar2vWEPRPThuX_sJ3W_VsdMCPDoCJlkzDtHM1qc_uLaBRsrCvThwWELbeow62RK3Recj2qxd8P-x8hOrMsWd</recordid><startdate>20040401</startdate><enddate>20040401</enddate><creator>Niskanen, Leo</creator><creator>Jensen, Linda Elise</creator><creator>Råstam, Jacob</creator><creator>Nygaard-Pedersen, Lars</creator><creator>Erichsen, Knut</creator><creator>Vora, Jiten P</creator><general>EM Inc USA</general><general>Excerpta Medica</general><general>Elsevier Limited</general><scope>IQODW</scope><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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20040401</creationdate><title>Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus</title><author>Niskanen, Leo ; Jensen, Linda Elise ; Råstam, Jacob ; Nygaard-Pedersen, Lars ; Erichsen, Knut ; Vora, Jiten P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c419t-57d6fc2fd12889ce73849423fadd6d2b43acdc8232c4110e20aa16f0c332bc9f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Biological and medical sciences</topic><topic>biphasic insulin</topic><topic>Biphasic Insulins</topic><topic>Blood Glucose - drug effects</topic><topic>Cross-Over Studies</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Disposable Equipment</topic><topic>Female</topic><topic>FlexPen</topic><topic>Generalized linear models</topic><topic>Glycemic Index - drug effects</topic><topic>Humalog Pen</topic><topic>Humans</topic><topic>Hypoglycemic Agents - administration & dosage</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Injections, Subcutaneous</topic><topic>Insulin</topic><topic>Insulin - administration & dosage</topic><topic>Insulin - adverse effects</topic><topic>Insulin - analogs & derivatives</topic><topic>Insulin - therapeutic use</topic><topic>insulin analog</topic><topic>Insulin Aspart</topic><topic>Insulin Lispro</topic><topic>Insulin, Isophane</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Patient Satisfaction</topic><topic>Patients</topic><topic>pen device</topic><topic>Pharmacology. Drug treatments</topic><topic>Syringes</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Niskanen, Leo</creatorcontrib><creatorcontrib>Jensen, Linda Elise</creatorcontrib><creatorcontrib>Råstam, Jacob</creatorcontrib><creatorcontrib>Nygaard-Pedersen, Lars</creatorcontrib><creatorcontrib>Erichsen, Knut</creatorcontrib><creatorcontrib>Vora, Jiten P</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Niskanen, Leo</au><au>Jensen, Linda Elise</au><au>Råstam, Jacob</au><au>Nygaard-Pedersen, Lars</au><au>Erichsen, Knut</au><au>Vora, Jiten P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus</atitle><jtitle>Clinical therapeutics</jtitle><addtitle>Clin Ther</addtitle><date>2004-04-01</date><risdate>2004</risdate><volume>26</volume><issue>4</issue><spage>531</spage><epage>540</epage><pages>531-540</pages><issn>0149-2918</issn><eissn>1879-114X</eissn><abstract>Objective: The goal of this study was to compare the efficacy and safety profiles of biphasic insulin aspart 30 (30% soluble insulin aspart and 70% protaminated insulin aspart [BIAsp 30]) and biphasic insulin lispro 25 (25% soluble insulin lispro and 75% neutral protamine lispro [Mix25]) used in a BID injection regimen in patients with type 2 diabetes mellitus (DM). Also assessed was patients' preference for pen device—the NovoMix® 30 FlexPen®/NovoLog® Mix 70/30 FlexPen® (FlexPen) versus the Humalog® Mix25
TM Pen/Humalog® Mix75/25
TM Pen (Humalog Pen).
Methods: Patients with type 2 DM receiving current insulin treatment were randomized to a multinational, multicenter, open-label, 2-period, crossover comparison of BIAsp 30 and Mix25. Efficacy (by analyses of variance) and safety profiles were assessed after 12 weeks of treatment. Patients' preference for pen device was assessed by questionnaires.
Results: A total of 137 patients were randomized to treatment; 4 were withdrawn during the 2-week run-in treatment with biphasic human insulin 30. The mean (SD) characteristics of the remaining 133 patients (79 men, 54 women) were as follows: age, 62.3 (9.2) years; body mass index, 28.1 (3.9) kg/m
2; and glycosylatd hemoglobin (HbA
1c), 8.5% (1.1). Glycemic control was assessed by the measurement of HbA
1c after 12 weeks of treatment. Treatment with BIAsp 30 was noninferior to treatment with Mix25 (upper limit of 90% CI for estimated difference [BIAsp 30 - Mix25] was <0.4%). Self-monitored blood glucose levels were comparable (
P = NS). Adverse-event profiles were similar between treatments, as was the incidence of hypoglycemic episodes (0.69 episode/mo with BIAsp 30 and 0.62 episode/mo with Mix25, P = 0.292). For all device features assessed, the FlexPen consistently received higher scores (all
P < 0.005). A total of 9.0% of patients experienced problems with the FlexPen, compared with 32.4% with the Humalog Pen (
P < 0.001). Furthermore, 74.6% preferred to continue using the FlexPen, whereas 14.3% preferred the Humalog Pen (
P < 0.001).
Conclusions: In this study, glycemic control with BIAsp 30 and Mix25 was found to be comparable in these patients with type 2 DM. Safety profiles were similar for both regimens. Patients preferred and experienced fewer problems with the FlexPen than the Humalog Pen.</abstract><cop>Belle Mead, NJ</cop><pub>EM Inc USA</pub><pmid>15189750</pmid><doi>10.1016/S0149-2918(04)90055-0</doi><tpages>10</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0149-2918 |
| ispartof | Clinical therapeutics, 2004-04, Vol.26 (4), p.531-540 |
| issn | 0149-2918 1879-114X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_72004507 |
| source | MEDLINE; Elsevier ScienceDirect Journals; ProQuest Central UK/Ireland |
| subjects | Biological and medical sciences biphasic insulin Biphasic Insulins Blood Glucose - drug effects Cross-Over Studies Diabetes Diabetes Mellitus, Type 2 - drug therapy Disposable Equipment Female FlexPen Generalized linear models Glycemic Index - drug effects Humalog Pen Humans Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - adverse effects Hypoglycemic Agents - therapeutic use Injections, Subcutaneous Insulin Insulin - administration & dosage Insulin - adverse effects Insulin - analogs & derivatives Insulin - therapeutic use insulin analog Insulin Aspart Insulin Lispro Insulin, Isophane Male Medical sciences Middle Aged Patient Satisfaction Patients pen device Pharmacology. Drug treatments Syringes Treatment Outcome |
| title | Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus |
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