The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3
Abstract Aims To evaluate the effect of concomitant dipeptidyl peptidase IV inhibitor (DPPIVi) use on efficacy and safety of insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100) in people with type 2 diabetes on oral antihyperglycaemic drugs. Methods A post hoc patient-level me...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science
2018
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| Online Access: | http://eprints.uanl.mx/17157/1/262.pdf |
| _version_ | 1824414809598197760 |
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| author | Yale, Jean François Pettus, Jeremy Hodson Brito Sanfiel, Miguel Lavalle González, Fernando Javier Merino Trigo, Ana Stella, Peter Chevalier, Soazig Buzzetti, Raffaella |
| author_facet | Yale, Jean François Pettus, Jeremy Hodson Brito Sanfiel, Miguel Lavalle González, Fernando Javier Merino Trigo, Ana Stella, Peter Chevalier, Soazig Buzzetti, Raffaella |
| author_sort | Yale, Jean François |
| collection | Repositorio Institucional |
| description | Abstract
Aims
To evaluate the effect of concomitant dipeptidyl peptidase IV inhibitor (DPPIVi) use on efficacy and safety of insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100) in people with type 2 diabetes on oral antihyperglycaemic drugs.
Methods
A post hoc patient-level meta-analysis was performed using data from EDITION 2 (basal insulin [N = 811]) and EDITION 3 (insulin-naïve [N = 878]), multicentre, randomised, openlabel, parallel-group, phase 3a trials of similar design. Endpoints analysed included HbA1c, hypoglycaemia and adverse events, investigated in subgroups of participants with and without concomitant DPPIVi use.
Results
Of 1689 participants randomised, 107 (13%, Gla-300) and 133 (16%, Gla-100) received DPPIVi therapy. The least squares mean change in HbA1c (baseline to month 6) was comparable between treatment groups, irrespective of DPPIVi use (no evidence of heterogeneity of treatment effect across subgroups, p = 0.753), although group sizes were unbalanced. The cumulative mean number of confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemic events, and the risk and annualised rate of such events, were consistently lower for Gla-300 than Gla-100 during the night (between 00:00 and 05:59 h) or at any time of day (24 h period), irrespective of DPPIVi use. Severe hypoglycaemia occurred in 8/838 and 10/844 participants in the Gla-300 and Gla-100 groups, respectively, and was not affected by DPPIVi use. The adverse event profile was similar between treatment groups and DPPIVi subgroups.
Conclusions
Glycaemic control with Gla-300 was comparable to Gla-100, with less hypoglycaemia during the night and at any time of day (24 h), irrespective of concomitant DPPIVi use. |
| format | Article |
| id | eprints-17157 |
| institution | UANL |
| language | English |
| publishDate | 2018 |
| publisher | Public Library of Science |
| record_format | eprints |
| spelling | eprints-171572024-03-05T15:36:00Z http://eprints.uanl.mx/17157/ The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3 Yale, Jean François Pettus, Jeremy Hodson Brito Sanfiel, Miguel Lavalle González, Fernando Javier Merino Trigo, Ana Stella, Peter Chevalier, Soazig Buzzetti, Raffaella Q Ciencias en General Abstract Aims To evaluate the effect of concomitant dipeptidyl peptidase IV inhibitor (DPPIVi) use on efficacy and safety of insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100) in people with type 2 diabetes on oral antihyperglycaemic drugs. Methods A post hoc patient-level meta-analysis was performed using data from EDITION 2 (basal insulin [N = 811]) and EDITION 3 (insulin-naïve [N = 878]), multicentre, randomised, openlabel, parallel-group, phase 3a trials of similar design. Endpoints analysed included HbA1c, hypoglycaemia and adverse events, investigated in subgroups of participants with and without concomitant DPPIVi use. Results Of 1689 participants randomised, 107 (13%, Gla-300) and 133 (16%, Gla-100) received DPPIVi therapy. The least squares mean change in HbA1c (baseline to month 6) was comparable between treatment groups, irrespective of DPPIVi use (no evidence of heterogeneity of treatment effect across subgroups, p = 0.753), although group sizes were unbalanced. The cumulative mean number of confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemic events, and the risk and annualised rate of such events, were consistently lower for Gla-300 than Gla-100 during the night (between 00:00 and 05:59 h) or at any time of day (24 h period), irrespective of DPPIVi use. Severe hypoglycaemia occurred in 8/838 and 10/844 participants in the Gla-300 and Gla-100 groups, respectively, and was not affected by DPPIVi use. The adverse event profile was similar between treatment groups and DPPIVi subgroups. Conclusions Glycaemic control with Gla-300 was comparable to Gla-100, with less hypoglycaemia during the night and at any time of day (24 h), irrespective of concomitant DPPIVi use. Public Library of Science 2018-01-25 Article PeerReviewed text en cc_by_nc_nd http://eprints.uanl.mx/17157/1/262.pdf http://eprints.uanl.mx/17157/1.haspreviewThumbnailVersion/262.pdf Yale, Jean François y Pettus, Jeremy Hodson y Brito Sanfiel, Miguel y Lavalle González, Fernando Javier y Merino Trigo, Ana y Stella, Peter y Chevalier, Soazig y Buzzetti, Raffaella (2018) The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3. PloS one, 13 (1). pp. 1-12. ISSN 1932-6203 http://doi.org/10.1371/journal.pone.0190579 doi:10.1371/journal.pone.0190579 |
| spellingShingle | Q Ciencias en General Yale, Jean François Pettus, Jeremy Hodson Brito Sanfiel, Miguel Lavalle González, Fernando Javier Merino Trigo, Ana Stella, Peter Chevalier, Soazig Buzzetti, Raffaella The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3 |
| thumbnail | https://rediab.uanl.mx/themes/sandal5/images/online.png |
| title | The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3 |
| title_full | The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3 |
| title_fullStr | The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3 |
| title_full_unstemmed | The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3 |
| title_short | The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3 |
| title_sort | effect of concomitant dppivi use on glycaemic control and hypoglycaemia with insulin glargine 300 u ml gla 300 versus insulin glargine 100 u ml gla 100 in people with type 2 diabetes a patient level meta analysis of edition 2 and 3 |
| topic | Q Ciencias en General |
| url | http://eprints.uanl.mx/17157/1/262.pdf |
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