Search: onr:"swepub:oai:DiVA.org:oru-42065" > Better glycaemic co...
Fältnamn | Indikatorer | Metadata |
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000 | 04324naa a2200373 4500 | |
001 | oai:DiVA.org:oru-42065 | |
003 | SwePub | |
008 | 150119s2014 | |||||||||||000 ||eng| | |
024 | 7 | a https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-420652 URI |
024 | 7 | a https://doi.org/10.1007/s00125-014-3355-02 DOI |
040 | a (SwePub)oru | |
041 | a engb eng | |
042 | 9 SwePub | |
072 | 7 | a vet2 swepub-contenttype |
072 | 7 | a art2 swepub-publicationtype |
100 | 1 | a Jendle, Johan,d 1963-u Örebro universitet,Institutionen för hälsovetenskap och medicin,Endocrine and Diabetes Center, University of Örebro, Örebro, Sweden4 aut0 (Swepub:oru)jje |
245 | 1 0 | a Better glycaemic control and less weight gain with once weekly dulaglutide vs bedtime insulin glargine, both combined with thrice daily lispro, in type 2 diabetes (AWARD-4) |
264 | c 2014-08-19 | |
264 | 1 | b Springer Science and Business Media LLC,c 2014 |
338 | a print2 rdacarrier | |
520 | a Background and aims: This 52 week, parallel-arm, open-label, phase 3 study compared two doses of the once weekly GLP-1 receptor agonist dulaglutide (DU) versus bedtime insulin glargine, all combined with pre-meal insulin lispro with or without metformin, in patients with type 2 diabetes mellitus inadequately controlled on conventional insulin therapy. Insulin glargine and insulin lispro were titrated to attempt to reach glycaemic targets.Materials and methods: Patients (N = 884; mean baseline characteristics: age 59.4 years; duration of diabetes 12.7 years; HbA1c 8.5%; body weight 91.1 kg; BMI 32.5 kg/m2; total daily insulin dose 56 U) were randomised (1:1:1) to once weekly DU 1.5 mg, DU 0.75 mg, or bedtime insulin glargine titrated-to-target. The primary objective was to compare the change in HbA1c from baseline of DU 1.5 mg with insulin glargine at 26 weeks for noninferiority (margin 0.4%) and if met, then superiority was tested.Results: At 26 and 52 weeks, both DU doses were statistically superior to insulin glargine for HbA1c change from baseline. Insulin glargine was associ-ated with greater fasting serum glucose reduction compared with both DU doses. The mean prandial insulin doses at 26 weeks were 93 U for DU 1.5 mg, 97 U for DU 0.75 mg, and 68 U for insulin glargine. The insulin glargine dose was 65 U. Similar insulin doses were observed at 52 weeks. Body weight decreased with DU 1.5 mg and increased with DU 0.75 mg and insulin glar-gine at 52 weeks. The rate of documented symptomatic hypoglycaemia (≤3.9 mmol/L) at 52 weeks was 31.0, 35.0,and 39.9 events/patient/year for DU 1.5 mg, DU 0.75 mg, and insulin glargine, respectively. The number of severe hypoglycaemia events was 11 for DU 1.5 mg, 15 for DU 0.75 mg, and 22 for insulin glargine. Nausea, diarrhoea, and vomiting were more common with DU 1.5 mg (25.8%, 16.6%, and 12.2%, respectively) and DU 0.75 mg (17.7%, 15.7%, and 10.6%) versus insulin glargine (3.4%, 6.1%, and 1.7%).Conclusion: DU compared to insulin glargine, both combined with insu-lin lispro, resulted in better glycaemic control, less body weight gain, no in-creased risk of hypoglycaemia, and more common reporting of gastrointes-tinal adverse events. | |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Endokrinologi och diabetes0 (SwePub)302052 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Endocrinology and Diabetes0 (SwePub)302052 hsv//eng |
700 | 1 | a Blonde, L.u Ochsner Medical Center, New Orleans LA, USA4 aut |
700 | 1 | a Rosenstock, J.u Dallas Diabetes and Endocrine Center, Dallas, USA4 aut |
700 | 1 | a Woo, V.u University of Manitoba, Winnipeg, Canada4 aut |
700 | 1 | a Gross, J.u Federal University of Rio Grande do Sul, Porto Alegre, Brazil4 aut |
700 | 1 | a Jiang, H.u Eli Lilly and Company, Indianapolis, USA4 aut |
700 | 1 | a Milicevic, Z.u Eli Lilly and Company, Vienna, Austria4 aut |
710 | 2 | a Örebro universitetb Institutionen för hälsovetenskap och medicin4 org |
773 | 0 | t Diabetologiad : Springer Science and Business Media LLCg 57:Suppl 1, s. S23-S24q 57:Suppl 1<S23-S24x 0012-186Xx 1432-0428 |
856 | 4 | u https://link.springer.com/content/pdf/10.1007%2Fs00125-014-3355-0.pdf |
856 | 4 8 | u https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-42065 |
856 | 4 8 | u https://doi.org/10.1007/s00125-014-3355-0 |
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