Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2020 Mar;22(3):365-372.
doi: 10.1111/dom.13904. Epub 2019 Dec 4.

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

Thomas C Blevins  1 , Abhijit Barve  2 , Yaron Raiter  3 , Patrick Aubonnet  4 , Sandeep Athalye  5 , Bin Sun  2 , Rafael Muniz  2
Affiliations
Clinical Trial

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

Thomas C Blevins et al. Diabetes Obes Metab. 2020 Mar.

Abstract

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.

Keywords: biosimilar; insulin glargine; switch; type 1 diabetes.

PubMed Disclaimer

Conflict of interest statement

T.C.B. has received clinical research support from AstraZeneca, Eli Lilly, Lexicon, Merck, Mylan, Novo Nordisk and Sanofi. A.B., Y.R., P.A., B.S. and R.M. are paid employees of Mylan Inc. and may hold stock or stock options in the company. S.A. is a paid employee of Biocon Research Ltd and may hold stock or stock options in the company.

Figures

Figure 1
Figure 1
A, Least squares mean change in glycated haemoglobin (HbA1c; %) from baseline at week 36, B, least squares mean difference in HbA1c (%) from baseline at week 36 between the MYL‐1501D and reference insulin glargine (IG) treatment sequences showing the confidence interval (CI) for equivalence (equivalence was declared if the 95% CI was within the prescribed acceptance range of ±0.4), and C, mean change in HbA1c (%) over time by treatment sequence. Error bars in panel A represent the standard error and in panel C represent the standard deviation
Figure 2
Figure 2
Mean actual MYL‐1501D or reference insulin glargine (IG) daily basal insulin dose over time. Error bars represent the standard deviation
Figure 3
Figure 3
Incidence of (A) anytime and (B) nocturnal hypoglycaemic events and mean actual (C) anytime and (D) nocturnal hypoglycaemic event rates (number of episodes per 30 days) by visit and treatment sequence. Error bars represent the standard deviation. IG, insulin glargine
See this image and copyright information in PMC

References

    1. American Diabetes Association , Classification and diagnosis of diabetes . 2. Classification and Diagnosis of Diabetes. Diabetes Care. 2017;40(suppl 1):S11‐S24. - PubMed
    1. American Diabetes Association . Glycemic targets. Diabetes Care. 2017;40(suppl 1):S48‐S56. - PubMed
    1. Diabetes Control and Complications Trial Research Group , Nathan DM, Genuth S, et al. The effect of intensive treatment of diabetes on the development and progression of long‐term complications in insulin‐dependent diabetes mellitus. N Engl J Med. 1993;329(14):977—986. - PubMed
    1. Nathan DM, Cleary PA, Backlund JY, et al. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005;353:2643‐2653. - PMC - PubMed
    1. Lantus [package insert] . Bridgewater. Sanofi‐Aventis US LLC: NJ; 2015.

Publication types

MeSH terms

LinkOut - more resources