Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 2 diabetes : A randomized, open-label clinical trial
© 2018 John Wiley & Sons Ltd..
AIM: To compare the efficacy and safety of MK-1293 insulin glargine (Mk-Gla) and Lantus (Sa-Gla) in people with type 2 diabetes mellitus (T2DM).
MATERIALS AND METHODS: This Phase 3, randomized, active-controlled, open-label, 24-week clinical trial (ClinicalTrials.gov number NCT02059187) enrolled 531 participants with T2DM (HbA1c ≤11.0%) either eligible for or currently taking basal insulin (≥10 U/day). Participants were randomized 1:1 to once-daily Mk-Gla (n = 263) or Sa-Gla (n = 263). Titration of insulin was guided by a fasting plasma glucose (FPG)-based dosing algorithm. The primary efficacy objective was to demonstrate the non-inferiority of change from baseline in HbA1c (margin of 0.40% [4.4 mmol/mol]) with Mk-Gla versus Sa-Gla after 24 weeks. The primary safety objective was anti-insulin antibody development after 24 weeks.
RESULTS: For Mk-Gla and Sa-Gla, the least squares (LS) mean HbA1c change from baseline (95% CI) was -1.28 (-1.41, -1.15)% (-14.0 [-15.4, -12.6] mmol/mol) and -1.30 (-1.43, -1.18)% (-14.2 [-15.6, -12.8] mmol/mol). The LS mean HbA1c difference (Mk-Gla minus Sa-Gla) was 0.03 (-0.12, 0.18)% (0.3 [-1.4, 1.9] mmol/mol), meeting non-inferiority and equivalence (secondary objective) criteria. Insulin doses, FPG, and seven-point plasma glucose profiles were similar between groups. Safety and tolerability, including anti-insulin antibody responses, hypoglycaemia, adverse events and body weight, were similar between insulins. The efficacy and safety of Mk-Gla and Sa-Gla were similar both in participants who were insulin-treated or insulin-naïve at baseline.
CONCLUSIONS: Mk-Gla and Sa-Gla demonstrated similar efficacy and safety over 24 weeks of treatment in people with T2DM.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2018 |
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| Erschienen: |
2018 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:20 |
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| Enthalten in: |
Diabetes, obesity & metabolism - 20(2018), 9 vom: 10. Sept., Seite 2229-2237 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hollander, Priscilla A [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 05.02.2019 Date Revised 07.12.2022 published: Print-Electronic ClinicalTrials.gov: NCT02059187 Citation Status MEDLINE |
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| doi: |
10.1111/dom.13363 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM284082236 |
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| 100 | 1 | |a Hollander, Priscilla A |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 2 diabetes |b A randomized, open-label clinical trial |
| 264 | 1 | |c 2018 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 05.02.2019 | ||
| 500 | |a Date Revised 07.12.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02059187 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2018 John Wiley & Sons Ltd. | ||
| 520 | |a AIM: To compare the efficacy and safety of MK-1293 insulin glargine (Mk-Gla) and Lantus (Sa-Gla) in people with type 2 diabetes mellitus (T2DM) | ||
| 520 | |a MATERIALS AND METHODS: This Phase 3, randomized, active-controlled, open-label, 24-week clinical trial (ClinicalTrials.gov number NCT02059187) enrolled 531 participants with T2DM (HbA1c ≤11.0%) either eligible for or currently taking basal insulin (≥10 U/day). Participants were randomized 1:1 to once-daily Mk-Gla (n = 263) or Sa-Gla (n = 263). Titration of insulin was guided by a fasting plasma glucose (FPG)-based dosing algorithm. The primary efficacy objective was to demonstrate the non-inferiority of change from baseline in HbA1c (margin of 0.40% [4.4 mmol/mol]) with Mk-Gla versus Sa-Gla after 24 weeks. The primary safety objective was anti-insulin antibody development after 24 weeks | ||
| 520 | |a RESULTS: For Mk-Gla and Sa-Gla, the least squares (LS) mean HbA1c change from baseline (95% CI) was -1.28 (-1.41, -1.15)% (-14.0 [-15.4, -12.6] mmol/mol) and -1.30 (-1.43, -1.18)% (-14.2 [-15.6, -12.8] mmol/mol). The LS mean HbA1c difference (Mk-Gla minus Sa-Gla) was 0.03 (-0.12, 0.18)% (0.3 [-1.4, 1.9] mmol/mol), meeting non-inferiority and equivalence (secondary objective) criteria. Insulin doses, FPG, and seven-point plasma glucose profiles were similar between groups. Safety and tolerability, including anti-insulin antibody responses, hypoglycaemia, adverse events and body weight, were similar between insulins. The efficacy and safety of Mk-Gla and Sa-Gla were similar both in participants who were insulin-treated or insulin-naïve at baseline | ||
| 520 | |a CONCLUSIONS: Mk-Gla and Sa-Gla demonstrated similar efficacy and safety over 24 weeks of treatment in people with T2DM | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Equivalence Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a MK-1293 | |
| 650 | 4 | |a biosimilar insulin | |
| 650 | 4 | |a insulin glargine | |
| 650 | 4 | |a type 2 diabetes | |
| 650 | 7 | |a Blood Glucose |2 NLM | |
| 650 | 7 | |a Glycated Hemoglobin A |2 NLM | |
| 650 | 7 | |a Hypoglycemic Agents |2 NLM | |
| 650 | 7 | |a Insulin Antibodies |2 NLM | |
| 650 | 7 | |a hemoglobin A1c protein, human |2 NLM | |
| 650 | 7 | |a Insulin Glargine |2 NLM | |
| 650 | 7 | |a 2ZM8CX04RZ |2 NLM | |
| 700 | 1 | |a Carofano, Wendy L |e verfasserin |4 aut | |
| 700 | 1 | |a Lam, Raymond L H |e verfasserin |4 aut | |
| 700 | 1 | |a Golm, Gregory T |e verfasserin |4 aut | |
| 700 | 1 | |a Eldor, Roy |e verfasserin |4 aut | |
| 700 | 1 | |a Crutchlow, Michael F |e verfasserin |4 aut | |
| 700 | 1 | |a Marcos, Michael C |e verfasserin |4 aut | |
| 700 | 1 | |a Rendell, Marc S |e verfasserin |4 aut | |
| 700 | 1 | |a Home, Philip D |e verfasserin |4 aut | |
| 700 | 1 | |a Gallwitz, Baptist |e verfasserin |4 aut | |
| 700 | 1 | |a Rosenstock, Julio |e verfasserin |4 aut | |
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