Efficacy and safety of MYL‐1501D versus insulin glargine in people with type 1 diabetes mellitus: Results of the INSTRIDE 3 phase 3 switch study
Aims To assess the efficacy, insulin dose, safety and immunogenicity when people with type 1 diabetes mellitus switched between MYL‐1501D and reference insulin glargine (Lantus®; Sanofi‐Aventis US LLC, Bridgewater, New Jersey). Materials and methods Eligible participants from INSTRIDE 1 who complete...
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Published in | Diabetes, obesity & metabolism Vol. 22; no. 3; pp. 365 - 372 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
Published |
Oxford, UK
Blackwell Publishing Ltd
01.03.2020
Wiley Subscription Services, Inc |
Subjects | |
Online Access | Get full text |
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Summary: | Aims
To assess the efficacy, insulin dose, safety and immunogenicity when people with type 1 diabetes mellitus switched between MYL‐1501D and reference insulin glargine (Lantus®; Sanofi‐Aventis US LLC, Bridgewater, New Jersey).
Materials and methods
Eligible participants from INSTRIDE 1 who completed 52 weeks of reference insulin glargine treatment were randomized 1:1 to the reference sequence (n = 63; reference insulin glargine for 36 weeks) or to the treatment‐switching sequence (n = 64; MYL‐1501D [weeks 0–12], reference insulin glargine [weeks 12–24] and MYL‐1501D [weeks 24–36]). Change in glycated haemoglobin (HbA1c) from baseline to week 36 was the primary efficacy endpoint used to demonstrate equivalence between the two treatment sequences. Secondary endpoints included: change in fasting plasma glucose (FPG), self‐monitored blood glucose (SMBG) and insulin dose; immunogenicity; and adverse events, including hypoglycaemia.
Results
Mean changes in HbA1c (least squares [LS] mean [SE]) from baseline to week 36 were −0.05 (0.032) and −0.06 (0.034) for the treatment‐switching and reference sequences, respectively (LS mean difference 0.01 [95% CI −0.085 to 0.101]). Treatment sequences were comparable in terms of secondary endpoints, including FPG, SMBG and insulin dose, and the safety and immunogenicity profiles of the two sequences were similar.
Conclusions
Switching participants between MYL‐1501D and reference insulin glargine demonstrated equivalent efficacy and similar safety and immunogenicity, showing that people taking reference insulin glargine can safely switch to MYL‐1501D. |
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Bibliography: | Funding information Financial support for this study was provided by Mylan Inc, Canonsburg, Pennsylvania, and Biocon Ltd, Bangalore, India. Editorial assistance was provided under the direction of the authors by Elizabeth A. Harvie, PhD, ELS and Jennifer Rossi, MA, ELS, MedThink SciCom, with support from Mylan Inc. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 ObjectType-News-3 content type line 23 Peer Review The peer review history for this article is available at https://publons.com/publon/10.1111/dom.13904. Funding information Financial support for this study was provided by Mylan Inc, Canonsburg, Pennsylvania, and Biocon Ltd, Bangalore, India. Editorial assistance was provided under the direction of the authors by Elizabeth A. Harvie, PhD, ELS and Jennifer Rossi, MA, ELS, MedThink SciCom, with support from Mylan Inc. |
ISSN: | 1462-8902 1463-1326 |
DOI: | 10.1111/dom.13904 |