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Transferring type 2 diabetes patients with uncontrolled glycaemia from biphasic human insulin to biphasic insulin aspart 30: Experiences from the PRESENT study

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dc.contributor.author Shestakova M.
dc.contributor.author Sharma S.K.
dc.contributor.author Almustafa M.
dc.contributor.author Min K.W.
dc.contributor.author Ayad N.
dc.contributor.author Azar S.T.
dc.contributor.author Danciulescu R.
dc.contributor.author Khutsoane D.
dc.contributor.author Guler S.
dc.contributor.editor
dc.date Dec-2007
dc.date.accessioned 2017-10-05T15:39:05Z
dc.date.available 2017-10-05T15:39:05Z
dc.date.issued 2007
dc.identifier 10.1185/030079907X253636
dc.identifier.isbn
dc.identifier.issn 03007995
dc.identifier.uri http://hdl.handle.net/10938/16672
dc.description.abstract Aim: The Physician's Routine Evaluation of Safety and Efficacy of NovoMix* 30 Therapy (PRESENT) aims to assess the safety and efficacy of biphasic insulin aspart (BIAsp30) used in routine clinical practice. Methods: This was a large, multi-national, multi-centre, prospective, 6-month study in type 2 diabetes mellitus patients who were prescribed BIAsp30. Efficacy endpoints included changes in HbA1c, fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), and proportion who achieved target HbA 1c andlt;7percent. Changes from baseline were analysed using paired t-test. Safety endpoints were incidence and rate of hypoglycaemic episodes. A subgroup of patients previously uncontrolled (HbA1c ≥7.0percent) on biphasic human insulin (BHI) were analysed. Results: Glycaemia improved significantly (mean ± SD): HbA1c by 1.58 ± 1.69percent points (from 9.32 ± 1.64percent to 7.70 ± 1.29percent), FPG by 2.92 ± 3.71 mmol-L and PPPG by 4.75 ± 4.87 mmol-L. The incidence of hypoglycaemic episodes decreased over time, from 38.7percent (baseline) to 20.8percent (6 months). Episodes were mostly minor (reduced from 37.7 to 20.6percent at 6 months), occurring during the day (reduced from 31.5 to 17.1percent at 6 months). Major episodes were less frequently reported (reduced from 5.0 to 0.4percent at 6 months). The rate of hypoglycaemia (episodes-patient year) from baseline to end of study decreased over time for overall (8.9-2.2), major (0.7-0.1), minor (8.2-2.2) and nocturnal (2.9-0.5) episodes. Conclusions: In this observational study, in the type 2 diabetes mellitus patients who were poorly controlled on BHI, glycaemia improved when transferred to BIAsp30, and a lower incidence or rate of hypoglycaemia was observed in these patients. © 2007 Librapharm Limited.
dc.format.extent
dc.format.extent Pages: (3209-3214)
dc.language English
dc.publisher LONDON
dc.relation.ispartof Publication Name: Current Medical Research and Opinion; Publication Year: 2007; Volume: 23; no. 12; Pages: (3209-3214);
dc.relation.ispartofseries
dc.relation.uri
dc.source Scopus
dc.subject.other
dc.title Transferring type 2 diabetes patients with uncontrolled glycaemia from biphasic human insulin to biphasic insulin aspart 30: Experiences from the PRESENT study
dc.type Article
dc.contributor.affiliation Shestakova, M., Institute of Diabetes, Moscow, Russian Federation, Institute of Diabetes, Federal Scientific Centre of Endocrinology, Federal Agency of Rosmedtechnology, Dmitryia Uljanova, No. 11, 117036 Moscow, Russian Federation
dc.contributor.affiliation Sharma, S.K., M.G. Medical College, Jaipur, India
dc.contributor.affiliation Almustafa, M., National Diabetes Center, Baghdad, Iraq
dc.contributor.affiliation Min, K.W., Eulji Hospital, Seoul, South Korea
dc.contributor.affiliation Ayad, N., Taiba Hospital, Kuwait, Kuwait
dc.contributor.affiliation Azar, S.T., American University of Beirut, Beirut, Lebanon
dc.contributor.affiliation Danciulescu, R., N. Paulescu Institute, Bucharest, Romania
dc.contributor.affiliation Khutsoane, D., Medi-Clinic, Bloemfontein, South Africa
dc.contributor.affiliation Guler, S., Ankara Numune Training and Research Hospital, Ankara, Turkey
dc.contributor.authorAddress Shestakova, M.; Institute of Diabetes, Federal Scientific Centre of Endocrinology, Federal Agency of Rosmedtechnology, Dmitryia Uljanova, No. 11, 117036 Moscow, Russian Federation; email: nephro@endocrincentr.ru
dc.contributor.authorCorporate University: American University of Beirut Medical Center; Faculty: Faculty of Medicine; Department: Internal Medicine;
dc.contributor.authorDepartment Internal Medicine
dc.contributor.authorDivision
dc.contributor.authorEmail nephro@endocrincentr.ru
dc.contributor.authorFaculty Faculty of Medicine
dc.contributor.authorInitials Shestakova, M
dc.contributor.authorInitials Sharma, SK
dc.contributor.authorInitials Almustafa, M
dc.contributor.authorInitials Min, KW
dc.contributor.authorInitials Ayad, N
dc.contributor.authorInitials Azar, ST
dc.contributor.authorInitials Danciulescu, R
dc.contributor.authorInitials Khutsoane, D
dc.contributor.authorInitials Guler, S
dc.contributor.authorOrcidID
dc.contributor.authorReprintAddress Shestakova, M (reprint author), Fed Agcy Rosmedtechnol, Fed Sci Ctr Endocrinol, Inst Diabet, Dmitryia Uljanova 11, Moscow 117036, Russia.
dc.contributor.authorResearcherID
dc.contributor.authorUniversity American University of Beirut Medical Center
dc.description.cited Abrahamian H, 2005, HORM METAB RES, V37, P684, DOI 10.1055-s-870579; American Diabetes Association, 2004, DIABETES CARE S1, V27, pS15; Boehm BO, 2002, DIABETIC MED, V19, P393, DOI 10.1046-j.1464-5491.2002.00733.x; Boehm BO, 2004, EUR J INTERN MED, V15, P496, DOI 10.1016-j.ejim.2004.10.001; Bolli GB, 1999, DIABETOLOGIA, V42, P1151, DOI 10.1007-s001250051286; Brange J, 1999, ADV DRUG DELIVER REV, V35, P307, DOI 10.1016-S0169-409X(98)00079-9; Davidson J, 2005, CLIN THER, V27, pS75, DOI 10.1016-j.clinthera.2005.11.022; Garber AJ, 2006, DIABETES OBES METAB, V8, P58, DOI 10.1111-j.1463-1326.2005.00563.x; HEINEMANN L, 1995, DIABETIC MED, V12, P449; International Diabetes Federation, 2005, IDF CLIN GUID TASK F; Jacobsen LV, 2000, EUR J CLIN PHARMACOL, V56, P399, DOI 10.1007-s002280000159; Liebl A, 2006, DIABETOLOGIA, V49, P610; LIGTHELM RJ, 2006, EXP CLIN ENDOCRINOL, V114, P5611; Ligthelm RJ, 2007, CLIN THER, V29, P1284, DOI 10.1016-j.clinthera.2007.07.004; McNally PG, 2007, DIABETES CARE, V30, P1044, DOI 10.2337-dc06-1328; McSorley PT, 2002, CLIN THER, V24, P530, DOI 10.1016-S0149-2918(02)85129-3; Overmann H, 1999, DIABETES RES CLIN PR, V43, P137, DOI 10.1016-S0168-8227(98)00132-6; Raskin P, 2005, DIABETES CARE, V28, P260, DOI 10.2337-diacare.28.2.260; Raskin PR, 2007, EUR J INTERN MED, V18, P56, DOI 10.1016-j.ejim.2006.09.006; Raz I, 2003, CLIN THER, V25, P3109, DOI 10.1016-S0149-2918(03)90095-6; Rizvi AA, 2007, INSULIN, V2, P68, DOI 10.1016-S1557-0843(07)80018-2; Schwartz S, 2003, DIABETES CARE, V26, P2238, DOI 10.2337-diacare.26.8.2238
dc.description.citedCount 26
dc.description.citedTotWOSCount 22
dc.description.citedWOSCount 20
dc.format.extentCount 6
dc.identifier.articleNo
dc.identifier.coden CMROC
dc.identifier.pubmedID 18005503
dc.identifier.scopusID 37749014620
dc.identifier.url
dc.publisher.address TELEPHONE HOUSE, 69-77 PAUL STREET, LONDON EC2A 4 LQ, ENGLAND
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dc.relation.ispartofConferenceDate
dc.relation.ispartofConferenceHosting
dc.relation.ispartofConferenceLoc
dc.relation.ispartofConferenceSponsor
dc.relation.ispartofConferenceTitle
dc.relation.ispartofFundingAgency
dc.relation.ispartOfISOAbbr Curr. Med. Res. Opin.
dc.relation.ispartOfIssue 12
dc.relation.ispartOfPart
dc.relation.ispartofPubTitle Current Medical Research and Opinion
dc.relation.ispartofPubTitleAbbr Curr. Med. Res. Opin.
dc.relation.ispartOfSpecialIssue
dc.relation.ispartOfSuppl
dc.relation.ispartOfVolume 23
dc.source.ID WOS:000252462600032
dc.type.publication Journal
dc.subject.otherAuthKeyword Biphasic human insulin
dc.subject.otherAuthKeyword Biphasic insulin aspart 30
dc.subject.otherAuthKeyword HbA1c
dc.subject.otherAuthKeyword Hypoglycaemia
dc.subject.otherAuthKeyword Type 2 diabetes mellitus
dc.subject.otherChemCAS biphasic insulin, 8063-29-4
dc.subject.otherChemCAS hemoglobin A1c, 62572-11-6
dc.subject.otherChemCAS insulin aspart, 116094-23-6
dc.subject.otherChemCAS Blood Glucose
dc.subject.otherChemCAS Hypoglycemic Agents
dc.subject.otherChemCAS Insulin, 11061-68-0
dc.subject.otherChemCAS insulin, Asp(B28)-
dc.subject.otherIndex antidiabetic agent
dc.subject.otherIndex biphasic insulin
dc.subject.otherIndex hemoglobin A1c
dc.subject.otherIndex insulin aspart
dc.subject.otherIndex adult
dc.subject.otherIndex article
dc.subject.otherIndex body weight
dc.subject.otherIndex clinical trial
dc.subject.otherIndex drug efficacy
dc.subject.otherIndex drug safety
dc.subject.otherIndex drug substitution
dc.subject.otherIndex female
dc.subject.otherIndex glucose blood level
dc.subject.otherIndex glucose brain level
dc.subject.otherIndex glycemic control
dc.subject.otherIndex human
dc.subject.otherIndex hypoglycemia
dc.subject.otherIndex major clinical study
dc.subject.otherIndex male
dc.subject.otherIndex monotherapy
dc.subject.otherIndex morbidity
dc.subject.otherIndex multicenter study
dc.subject.otherIndex non insulin dependent diabetes mellitus
dc.subject.otherIndex observational study
dc.subject.otherIndex postprandial state
dc.subject.otherIndex prospective study
dc.subject.otherIndex side effect
dc.subject.otherIndex Student t test
dc.subject.otherIndex Aged
dc.subject.otherIndex Blood Glucose
dc.subject.otherIndex Diabetes Mellitus, Type 2
dc.subject.otherIndex Female
dc.subject.otherIndex Humans
dc.subject.otherIndex Hyperglycemia
dc.subject.otherIndex Hypoglycemic Agents
dc.subject.otherIndex Insulin
dc.subject.otherIndex Male
dc.subject.otherIndex Middle Aged
dc.subject.otherIndex Treatment Outcome
dc.subject.otherKeywordPlus INJECTION-MEAL-INTERVAL
dc.subject.otherKeywordPlus DOUBLE-BLIND CROSSOVER
dc.subject.otherKeywordPlus BASAL INSULIN
dc.subject.otherKeywordPlus BIPHASIC-INSULIN-ASPART-30
dc.subject.otherKeywordPlus MELLITUS
dc.subject.otherKeywordPlus THERAPY
dc.subject.otherKeywordPlus ANALOGS
dc.subject.otherKeywordPlus BIPHASIC-HUMAN-INSULIN-30
dc.subject.otherWOS Medicine, General and Internal
dc.subject.otherWOS Medicine, Research and Experimental


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