Maurice B Bizino1, Ingrid M Jazet2, Huub J van Eyk2, Patrick C N Rensen2, Petronella H Geelhoed-Duijvestijn3, Aan V Kharagjitsingh2,4, Elisabeth H M Paiman5, Johannes W Smit6, Hildebrandus J Lamb5. 1. Department of Radiology, Leiden University Medical Center, LUMC Postzone C2S, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands. m.b.bizino@lumc.nl. 2. Department of Medicine, Division of Endocrinology, and Einthoven Laboratory for Experimental Vascular Medicine, Leiden University Medical Center, Leiden, The Netherlands. 3. Department of Medicine, Haaglanden Medical Center, The Hague, The Netherlands. 4. Department of Diabetology and Endocrinology and Diabetes Research Center, Vrije Universiteit Brussel, Brussels, Belgium. 5. Department of Radiology, Leiden University Medical Center, LUMC Postzone C2S, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands. 6. Department of Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
Abstract
AIMS: Data on the effect of liraglutide on glycemic endpoints in people with T2DM using multiple daily insulin injections (MDI) are scarce, especially in the context of ethnicity. METHODS: This is a secondary analysis of the placebo-controlled randomized clinical "MAGNA VICTORIA" trials in Western European (WE) and South Asian (SA) people with T2DM. Participants had inadequate glycemic control despite using metformin and/or sulfonylurea derivatives and/or insulin. Participants were assigned to liraglutide (1.8 mg) or placebo for 6 months, in addition to standard care. The primary endpoint number of participants reaching target HbA1c was compared for liraglutide versus placebo in the complete dataset and MDI-treated participants using Chi-square test. Liraglutide's efficacy in WE and SA was compared using a generalized linear model. RESULTS:Forty-five subjects were randomized to liraglutide and 51 to placebo. In each group, one participant did not complete the study. Liraglutide-treated patients reached target HbA1c more frequently: 23/45 (51%) vs 11/51 (22%), relative probability 2.4 (1.3-4.3), p = 0.002. Subgroup analysis in 43 MDI participants showed that the proportion reaching target HbA1c using liraglutide was significantly higher than in placebo: 9/22 (41%) vs 1/21 (5%), p = 0.005. There was no difference between WE and SA in terms of liraglutide efficacy (p = 0.18). CONCLUSIONS:Liraglutide treatment resulted in increased chance of reaching target HbA1c as compared to placebo. Liraglutide efficacy was sustained in participants using MDI regimens and those of SA descent. Liraglutide should be considered for T2DM people with inadequate glycemic control despite MDI.
RCT Entities:
AIMS: Data on the effect of liraglutide on glycemic endpoints in people with T2DM using multiple daily insulin injections (MDI) are scarce, especially in the context of ethnicity. METHODS: This is a secondary analysis of the placebo-controlled randomized clinical "MAGNA VICTORIA" trials in Western European (WE) and South Asian (SA) people with T2DM. Participants had inadequate glycemic control despite using metformin and/or sulfonylurea derivatives and/or insulin. Participants were assigned to liraglutide (1.8 mg) or placebo for 6 months, in addition to standard care. The primary endpoint number of participants reaching target HbA1c was compared for liraglutide versus placebo in the complete dataset and MDI-treated participants using Chi-square test. Liraglutide's efficacy in WE and SA was compared using a generalized linear model. RESULTS: Forty-five subjects were randomized to liraglutide and 51 to placebo. In each group, one participant did not complete the study. Liraglutide-treated patients reached target HbA1c more frequently: 23/45 (51%) vs 11/51 (22%), relative probability 2.4 (1.3-4.3), p = 0.002. Subgroup analysis in 43 MDI participants showed that the proportion reaching target HbA1c using liraglutide was significantly higher than in placebo: 9/22 (41%) vs 1/21 (5%), p = 0.005. There was no difference between WE and SA in terms of liraglutide efficacy (p = 0.18). CONCLUSIONS: Liraglutide treatment resulted in increased chance of reaching target HbA1c as compared to placebo. Liraglutide efficacy was sustained in participants using MDI regimens and those of SA descent. Liraglutide should be considered for T2DM people with inadequate glycemic control despite MDI.
Entities:
Keywords:
Glucagon-like peptide-1 receptor agonist; Liraglutide; Multiple daily insulin injections; South Asian; Type 2 diabetes mellitus
Authors: Angus G Jones; Timothy J McDonald; Beverley M Shields; Anita V Hill; Christopher J Hyde; Bridget A Knight; Andrew T Hattersley Journal: Diabetes Care Date: 2015-08-04 Impact factor: 19.112