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Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: Experience from the PRESENT study

Show simple item record Khutsoane D. Sharma S.K. Almustafa M. Jang H.C. Azar S.T. Danciulescu R. Shestakova M. Ayad N.M.A. Guler S. Bech O.M.
dc.contributor.editor Mar-2008 2017-10-05T15:37:27Z 2017-10-05T15:37:27Z 2008
dc.identifier 10.1111/j.1463-1326.2007.00826.x
dc.identifier.issn 14628902
dc.description.abstract Aim: The Physicians'Routine Evaluation of Safety and Efficacy of NovoMix® 30 Therapy (PRESENT) study aims to assess the safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) in patients with type 2 diabetes mellitus in routine clinical practice. Methods: This was a 6-month, prospective, multinational, multiethnic observational study involving 21977 patients from 13 countries (India, Iraq, Jordan, Kuwait, Lebanon, Qatar, Romania, Russia, Saudi Arabia, South Africa, South Korea, Turkey and the United Arab Emirates). The patients were transferred to BIAsp 30 with or without oral antidiabetic drugs (OADs) from prior treatment with OAD (n = 8583), insulin (n = 5942), OAD+insulin (n = 4673) or diet (i.e. treatment naive) (n = 1707). One thousand and seventy-two patients had incomplete or no information on previous treatment. Results: At 3 and 6 months, significant reductions from baseline were observed in the mean haemoglobin A 1c (HbA 1c) (-1.33 and -1.81percent), fasting plasma glucose (-3.02 and -3.74mmol-l) and postprandial plasma glucose (-4.76 and -5.82mmol-l) (p 0.001). A significantly greater proportion of patients achieved target HbA 1c of less than 7percent at 3months (15.3percent) and 6months (27.7percent) compared with baseline (4.8percent) (p 0.001). Overall, the mean HbA 1c at 6months was lowered in patients regardless of prior treatment: -2.15percent (OAD), -1.45percent (insulin), -1.47percent (OAD+insulin) and -2.35percent (treatment naive). In the overall cohort, the rate of total hypoglycaemia was reduced from 5.4 events per patient-year at baseline to 2.2 events per patient-year at study end (p 0.001). Among prior treatment subgroups, the rates of total hypoglycaemia were reduced from 2.5 to 2.1 events per patient-year in the OAD group, from 9.6 to 2.2 events per patient-year in the insulin group and from 7.6 to 2.5 events per patient-year in the OAD+insulin group but were increased from 1.0 to 1.8 events per patient-year in the treatment-naive group (p 0.001). There were 444 adverse drug reactions (ADRs), including 13 serious ADRs: lipodystrophy (three events), symptoms of generalized hypersensitivity (two events), acute painful neuropathy (one event), worsening of diabetic retinopathy (one event), oedema (one event) and unspecified ADRs (five events). Conclusion: The use of BIAsp 30 monotherapy or in combination with OADs in clinical practice was effective and safe in patients with poorly controlled type 2 diabetes mellitus. © 2008 Blackwell Publishing Ltd.
dc.format.extent Pages: (212-222)
dc.language English
dc.publisher OXFORD
dc.relation.ispartof Publication Name: Diabetes, Obesity and Metabolism; Publication Year: 2008; Volume: 10; no. 3; Pages: (212-222);
dc.source Scopus
dc.title Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: Experience from the PRESENT study
dc.type Article
dc.contributor.affiliation Khutsoane, D., Medi-Clinic, Kellner Street, Bloemfontein 9301, South Africa
dc.contributor.affiliation Sharma, S.K., Department of Medicine, M G Medical College, Jaipur, India
dc.contributor.affiliation Almustafa, M., Department of Diabetes, Al Mustansiriya University, Baghdad, Iraq
dc.contributor.affiliation Jang, H.C., Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea
dc.contributor.affiliation Azar, S.T., Department of Endocrinology, American University of Beirut, Beirut, Lebanon
dc.contributor.affiliation Danciulescu, R., Department of Diabetes, N. Paulescu Institute, Bucharest, Romania
dc.contributor.affiliation Shestakova, M., Institute of Diabetes, Federal Scientific Centre of Endocrinology, Moscow, Russian Federation
dc.contributor.affiliation Ayad, N.M.A., Department of Internal Medicine, Taiba Hospital, Kuwait
dc.contributor.affiliation Guler, S., Department of Endocrinology and Metabolism, Ankara Numune Training and Research Hospital, Ankara, Turkey
dc.contributor.affiliation Bech, O.M., Novo Nordisk International Operations Clinical Development Centre, Beijing, China
dc.contributor.authorAddress Khutsoane, D.; Medi-Clinic, Kellner Street, Bloemfontein 9301, South Africa; email:
dc.contributor.authorCorporate University: American University of Beirut Medical Center; Faculty: Faculty of Medicine; Department: Internal Medicine;
dc.contributor.authorDepartment Internal Medicine
dc.contributor.authorFaculty Faculty of Medicine
dc.contributor.authorInitials Khutsoane, D
dc.contributor.authorInitials Sharma, SK
dc.contributor.authorInitials Almustafa, M
dc.contributor.authorInitials Jang, HC
dc.contributor.authorInitials Azar, ST
dc.contributor.authorInitials Danciulescu, R
dc.contributor.authorInitials Shestakova, M
dc.contributor.authorInitials Ayad, NMA
dc.contributor.authorInitials Guler, S
dc.contributor.authorInitials Bech, OM
dc.contributor.authorReprintAddress Khutsoane, D (reprint author), Medi Clin, Suite 510,Kollner St, ZA-9301 Bloemfontein, South Africa.
dc.contributor.authorResearcherID Jang, Hak Chul-D-9637-2012
dc.contributor.authorUniversity American University of Beirut Medical Center
dc.description.cited American Diabetes Association, 2001, DIABETES CARE S1, V24, pS33; 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; Bonora E, 2001, DIABETOLOGIA, V44, P2107, DOI 10.1007-s001250100020; Chiasson JL, 2003, JAMA-J AM MED ASSOC, V290, P486, DOI 10.1001-jama.290.4.486; Christiansen JS, 2003, DIABETES OBES METAB, V5, P446, DOI 10.1046-j.1463-1326.2003.00300.x; Davidson J, 2005, CLIN THER, V27, pS75, DOI 10.1016-j.clinthera.2005.11.022; Davies M, 2005, DIABETES CARE, V28, P1282, DOI 10.2337-diacare.28.6.1282; De Backer G, 2003, EUR HEART J, V24, P1601, DOI 10.1016-S0195-668X(03)00347-6; El-Kebbi IM, 2004, DIABETES CARE, V27, P335, DOI 10.2337-diacare.27.2.335; Esposito K, 2004, CIRCULATION, V110, P214, DOI 10.1161-01.CIR.0000134501.57864.66; Garber AJ, 2006, DRUGS, V66, P31, DOI 10.2165-00003495-200666010-00003; Garber AJ, 2007, DIABETES OBES METAB, V9, P630, DOI 10.1111-j.1463-1326.2006.00654.x; Garber AJ, 2006, DIABETES OBES METAB, V8, P58, DOI 10.1111-j.1463-1326.2005.00563.x; Guven A, 2000, POSTGRAD MED J, V76, P150; Hanefeld M, 1996, DIABETOLOGIA, V39, P1577, DOI 10.1007-s001250050617; HENRICSSON M, 1995, DIABETES CARE, V18, P1571, DOI 10.2337-diacare.18.12.1571; HOLMAN RR, 1988, DIABETIC MED, V5, P582; Jacobsen LV, 2000, EUR J CLIN PHARMACOL, V56, P399, DOI 10.1007-s002280000159; Joshi S R, 2005, J Assoc Physicians India, V53, P775; KAPITZA C, 2004, DIABETIC MED, V21, P497; Kilo C, 2003, J DIABETES COMPLICAT, V17, P307, DOI 10.1016-S1056-8727(03)00076-X; Kitzmiller JL, 1999, DIABETES CARE, V22, P874, DOI 10.2337-diacare.22.5.874; Kvapil M, 2006, Diabetes Obes Metab, V8, P39, DOI 10.1111-j.1463-1326.2005.00492.x; Leiter LA, 2005, CLIN THER, V27, pS42, DOI 10.1016-j.clinthera.2005.11.020; LIGHTELM RJ, 2007, DIABETES S1, V56, pA540; Ligthelm RJ, 2007, CLIN THER, V29, P1284, DOI 10.1016-j.clinthera.2007.07.004; LLEWELYN JG, 1986, ACTA NEUROPATHOL, V72, P157; Mendoza Ana, 2005, Endocr Pract, V11, P91; Monnier L, 2003, DIABETES CARE, V26, P881, DOI 10.2337-diacare.26.3.881; Raskin P, 2005, DIABETES CARE, V28, P260, DOI 10.2337-diacare.28.2.260; ROYSARKAR TK, 1993, AM J OPHTHALMOL, V115, P560; Sievers ML, 1999, DIABETES, V48, P896, DOI 10.2337-diabetes.48.4.896; Sridhar GR, 2006, DIABETES RES CLIN PR, V71, P105, DOI 10.1016-j.diabres.2005.08.002; Turner RC, 1999, JAMA-J AM MED ASSOC, V281, P2005, DOI 10.1001-jama.281.21.2005; Turner RC, 1998, LANCET, V352, P837; Warren ML, 2004, DIABETES RES CLIN PR, V66, P23, DOI 10.1016-j.diabetes.2004.02.010; Zammitt NN, 2005, DIABETES CARE, V28, P2948, DOI 10.2337-diacare.28.12.2948
dc.description.citedCount 40
dc.description.citedTotWOSCount 32
dc.description.citedWOSCount 23
dc.format.extentCount 11
dc.identifier.coden DOMEF
dc.identifier.pubmedID 18269636
dc.identifier.scopusID 39049090368
dc.publisher.address 9600 GARSINGTON RD, OXFORD OX4 2DQ, OXON, ENGLAND
dc.relation.ispartOfISOAbbr Diabetes Obes. Metab.
dc.relation.ispartOfIssue 3
dc.relation.ispartofPubTitle Diabetes, Obesity and Metabolism
dc.relation.ispartofPubTitleAbbr Diabetes Obes. Metab.
dc.relation.ispartOfVolume 10
dc.source.ID WOS:000252929700003
dc.type.publication Journal
dc.subject.otherAuthKeyword Biphasic insulin aspart 30
dc.subject.otherAuthKeyword Clinical practice
dc.subject.otherAuthKeyword Insulin analogue
dc.subject.otherAuthKeyword Observational study
dc.subject.otherAuthKeyword PRESENT study
dc.subject.otherAuthKeyword Type 2 diabetes mellitus
dc.subject.otherChemCAS biguanide, 56-03-1
dc.subject.otherChemCAS glucose, 50-99-7, 84778-64-3
dc.subject.otherChemCAS hemoglobin A1c, 62572-11-6
dc.subject.otherChemCAS human insulin, 11061-68-0
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 biguanide
dc.subject.otherIndex glucose
dc.subject.otherIndex hemoglobin A1c
dc.subject.otherIndex human insulin
dc.subject.otherIndex insulin aspart
dc.subject.otherIndex insulin derivative
dc.subject.otherIndex oral antidiabetic agent
dc.subject.otherIndex sulfonylurea
dc.subject.otherIndex adult
dc.subject.otherIndex aged
dc.subject.otherIndex article
dc.subject.otherIndex clinical practice
dc.subject.otherIndex clinical trial
dc.subject.otherIndex combination chemotherapy
dc.subject.otherIndex controlled clinical trial
dc.subject.otherIndex controlled study
dc.subject.otherIndex diabetic retinopathy
dc.subject.otherIndex diet restriction
dc.subject.otherIndex disease control
dc.subject.otherIndex disease duration
dc.subject.otherIndex drug dose regimen
dc.subject.otherIndex drug efficacy
dc.subject.otherIndex drug hypersensitivity
dc.subject.otherIndex drug safety
dc.subject.otherIndex edema
dc.subject.otherIndex ethnic difference
dc.subject.otherIndex female
dc.subject.otherIndex glucose blood level
dc.subject.otherIndex glycemic control
dc.subject.otherIndex human
dc.subject.otherIndex hypoglycemia
dc.subject.otherIndex India
dc.subject.otherIndex Iraq
dc.subject.otherIndex Jordan
dc.subject.otherIndex Kuwait
dc.subject.otherIndex Lebanon
dc.subject.otherIndex lipodystrophy
dc.subject.otherIndex major clinical study
dc.subject.otherIndex male
dc.subject.otherIndex monotherapy
dc.subject.otherIndex multicenter study
dc.subject.otherIndex neuropathy
dc.subject.otherIndex non insulin dependent diabetes mellitus
dc.subject.otherIndex observational study
dc.subject.otherIndex postprandial state
dc.subject.otherIndex Qatar
dc.subject.otherIndex refraction error
dc.subject.otherIndex Romania
dc.subject.otherIndex Russian Federation
dc.subject.otherIndex Saudi Arabia
dc.subject.otherIndex side effect
dc.subject.otherIndex South Africa
dc.subject.otherIndex South Korea
dc.subject.otherIndex treatment duration
dc.subject.otherIndex Turkey (republic)
dc.subject.otherIndex United Arab Emirates
dc.subject.otherIndex unspecified side effect
dc.subject.otherIndex weight gain
dc.subject.otherIndex Blood Glucose
dc.subject.otherIndex Diabetes Mellitus, Type 2
dc.subject.otherIndex Family Practice
dc.subject.otherIndex Humans
dc.subject.otherIndex Hypoglycemia
dc.subject.otherIndex Hypoglycemic Agents
dc.subject.otherIndex Insulin
dc.subject.otherIndex Treatment Outcome
dc.subject.otherKeywordPlus BLOOD-GLUCOSE CONTROL
dc.subject.otherKeywordPlus CARDIOVASCULAR-DISEASE
dc.subject.otherKeywordPlus NPH INSULIN
dc.subject.otherKeywordPlus RISK
dc.subject.otherKeywordPlus HYPOGLYCEMIA
dc.subject.otherKeywordPlus MELLITUS
dc.subject.otherKeywordPlus NIDDM
dc.subject.otherKeywordPlus HYPERGLYCEMIA
dc.subject.otherKeywordPlus RETINOPATHY
dc.subject.otherKeywordPlus METFORMIN
dc.subject.otherWOS Endocrinology and Metabolism

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