Benefit of Early Add-on of Linagliptin to Insulin in Japanese Patients With Type 2 Diabetes Mellitus : Randomized-Controlled Open-Label Trial (TRUST2)
INTRODUCTION: This trial was conducted to assess the long-term safety, efficacy, and benefit of early add-on of linagliptin to insulin in patients with type 2 diabetes mellitus (T2DM).
METHODS: This trial enrolled 246 subjects. The subjects were randomized to the linagliptin group or the control group and were observed for 156 weeks. After week 16, subjects in the control group were also allowed to add linagliptin to evaluate the benefit of early add-on of linagliptin to insulin. The primary end point was a change in HbA1c from baseline to week 16. Secondary end points included fasting plasma glucose, daily insulin dose, and frequency of adverse events.
RESULTS: HbA1c and fasting plasma glucose levels significantly decreased from baseline to week 16 in the linagliptin group compared with the control group. The significant improvement in HbA1c continued until week 52. The daily insulin dose significantly decreased in the linagliptin group compared with the control group. The frequency of hypoglycemia and adverse events was comparable in both groups.
CONCLUSIONS: Add-on of linagliptin to insulin was tolerated, improved glycemic control, and reduced the daily insulin dose. This study demonstrates the long-term safety, efficacy and benefit of early add-on of linagliptin to insulin in Japanese T2DM patients.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:38 |
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| Enthalten in: |
Advances in therapy - 38(2021), 3 vom: 28. März, Seite 1514-1535 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Katsuno, Tomoyuki [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 14.04.2021 Date Revised 07.12.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1007/s12325-021-01631-y |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM320691462 |
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| 024 | 7 | |a 10.1007/s12325-021-01631-y |2 doi | |
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| 041 | |a eng | ||
| 100 | 1 | |a Katsuno, Tomoyuki |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Benefit of Early Add-on of Linagliptin to Insulin in Japanese Patients With Type 2 Diabetes Mellitus |b Randomized-Controlled Open-Label Trial (TRUST2) |
| 264 | 1 | |c 2021 | |
| 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 14.04.2021 | ||
| 500 | |a Date Revised 07.12.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a INTRODUCTION: This trial was conducted to assess the long-term safety, efficacy, and benefit of early add-on of linagliptin to insulin in patients with type 2 diabetes mellitus (T2DM) | ||
| 520 | |a METHODS: This trial enrolled 246 subjects. The subjects were randomized to the linagliptin group or the control group and were observed for 156 weeks. After week 16, subjects in the control group were also allowed to add linagliptin to evaluate the benefit of early add-on of linagliptin to insulin. The primary end point was a change in HbA1c from baseline to week 16. Secondary end points included fasting plasma glucose, daily insulin dose, and frequency of adverse events | ||
| 520 | |a RESULTS: HbA1c and fasting plasma glucose levels significantly decreased from baseline to week 16 in the linagliptin group compared with the control group. The significant improvement in HbA1c continued until week 52. The daily insulin dose significantly decreased in the linagliptin group compared with the control group. The frequency of hypoglycemia and adverse events was comparable in both groups | ||
| 520 | |a CONCLUSIONS: Add-on of linagliptin to insulin was tolerated, improved glycemic control, and reduced the daily insulin dose. This study demonstrates the long-term safety, efficacy and benefit of early add-on of linagliptin to insulin in Japanese T2DM patients | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a DPP-4 inhibitor | |
| 650 | 4 | |a Glycemic control | |
| 650 | 4 | |a Insulin | |
| 650 | 4 | |a Linagliptin | |
| 650 | 4 | |a Quality of life | |
| 650 | 4 | |a Type 2 diabetes mellitus | |
| 650 | 7 | |a Blood Glucose |2 NLM | |
| 650 | 7 | |a Dipeptidyl-Peptidase IV Inhibitors |2 NLM | |
| 650 | 7 | |a Glycated Hemoglobin A |2 NLM | |
| 650 | 7 | |a Hypoglycemic Agents |2 NLM | |
| 650 | 7 | |a Insulin |2 NLM | |
| 650 | 7 | |a Linagliptin |2 NLM | |
| 650 | 7 | |a 3X29ZEJ4R2 |2 NLM | |
| 700 | 1 | |a Shiraiwa, Toshihiko |e verfasserin |4 aut | |
| 700 | 1 | |a Iwasaki, Shingo |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Hyohun |e verfasserin |4 aut | |
| 700 | 1 | |a Watanabe, Nobuaki |e verfasserin |4 aut | |
| 700 | 1 | |a Kaneko, Shizuka |e verfasserin |4 aut | |
| 700 | 1 | |a Terasaki, Jungo |e verfasserin |4 aut | |
| 700 | 1 | |a Hanafusa, Toshiaki |e verfasserin |4 aut | |
| 700 | 1 | |a Imagawa, Akihisa |e verfasserin |4 aut | |
| 700 | 1 | |a Shimomura, Iichiro |e verfasserin |4 aut | |
| 700 | 1 | |a Ikegami, Hiroshi |e verfasserin |4 aut | |
| 700 | 1 | |a Koyama, Hidenori |e verfasserin |4 aut | |
| 700 | 1 | |a Namba, Mitsuyoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Miyagawa, Jun-Ichiro |e verfasserin |4 aut | |
| 700 | 0 | |a TRUST2 study group |e verfasserin |4 aut | |
| 700 | 1 | |a Seino, H |e investigator |4 oth | |
| 700 | 1 | |a Nakata, S |e investigator |4 oth | |
| 700 | 1 | |a Uchida, D |e investigator |4 oth | |
| 700 | 1 | |a Komi, R |e investigator |4 oth | |
| 700 | 1 | |a Ooka, A |e investigator |4 oth | |
| 700 | 1 | |a Tanaka, A |e investigator |4 oth | |
| 700 | 1 | |a Nawa, C |e investigator |4 oth | |
| 700 | 1 | |a Moriwaki, M |e investigator |4 oth | |
| 700 | 1 | |a Haseda, F |e investigator |4 oth | |
| 700 | 1 | |a Murata, K |e investigator |4 oth | |
| 700 | 1 | |a Hiromine, Y |e investigator |4 oth | |
| 700 | 1 | |a Nishimura, H |e investigator |4 oth | |
| 700 | 1 | |a Matsutani, S |e investigator |4 oth | |
| 700 | 1 | |a Tsunoda, T |e investigator |4 oth | |
| 700 | 1 | |a Konya, H |e investigator |4 oth | |
| 700 | 1 | |a Sakane, S |e investigator |4 oth | |
| 700 | 1 | |a Ohashi, H |e investigator |4 oth | |
| 700 | 1 | |a Nagao, A |e investigator |4 oth | |
| 700 | 1 | |a Arimitsu, A |e investigator |4 oth | |
| 700 | 1 | |a Kurebayashi, S |e investigator |4 oth | |
| 700 | 1 | |a Fujii, H |e investigator |4 oth | |
| 700 | 1 | |a Imbe, H |e investigator |4 oth | |
| 700 | 1 | |a Miyawaki, M |e investigator |4 oth | |
| 700 | 1 | |a Mishiba, Y |e investigator |4 oth | |
| 700 | 1 | |a Onishi, M |e investigator |4 oth | |
| 700 | 1 | |a Tanimoto, K |e investigator |4 oth | |
| 700 | 1 | |a Nakatsuji, F |e investigator |4 oth | |
| 700 | 1 | |a Kozawa, J |e investigator |4 oth | |
| 700 | 1 | |a Iwahashi, H |e investigator |4 oth | |
| 700 | 1 | |a Fukui, K |e investigator |4 oth | |
| 700 | 1 | |a Yamamoto, T |e investigator |4 oth | |
| 700 | 1 | |a Kojima, Y |e investigator |4 oth | |
| 700 | 1 | |a Aida, A |e investigator |4 oth | |
| 700 | 1 | |a Hiyoshi, T |e investigator |4 oth | |
| 700 | 1 | |a Menjyu, M |e investigator |4 oth | |
| 700 | 1 | |a Hayashi, I |e investigator |4 oth | |
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