PMID- 32141343 OWN - NLM STAT- MEDLINE DCOM- 20210311 LR - 20210311 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 36 IP - 5 DP - 2020 May TI - Comparative study of dulaglutide single-use pen Ateos versus insulin degludec FlexTouch on learning and mock administration time in Japanese patients with type 2 diabetes mellitus - a post-hoc analysis. PG - 765-769 LID - 10.1080/03007995.2020.1739636 [doi] AB - Aims: Clinical data have shown that patients with diabetes require shorter training time to use Ateos versus FlexTouch. Using data acquired from a previous study, self-administration procedures that necessitated more time and repetition during mock injection were evaluated.Methods: In this open-label task- and interview-based crossover study, 48 self-injection naive participants with type 2 diabetes mellitus (T2DM) were randomized to 1 of 2 sequences to perform a mock injection of Ateos and FlexTouch into a rubber pad after receiving training. Time needed to conduct mock injection steps (preparation, pre-injection set-up, injection, clean-up), and the number and time needed for repeated steps due to procedural errors, were measured as post-hoc analyses.Results: Mean time for preparation, injection, and clean-up was shorter for Ateos (13, 15, 9 s) versus FlexTouch (96, 53, 36 s). Overall time for administration including repeated steps was 75 s for Ateos and 288 s for FlexTouch. Nine participants repeated procedures due to errors when using Ateos (preparation: 6; pre-injection set-up: 2; injection: 1), and 7 participants when using FlexTouch (preparation: 2; pre-injection set-up: 2; injection: 5). There was 1 repeat per person for Ateos injections versus multiple repeats for FlexTouch injections.Conclusions:Post-hoc analysis demonstrates the time needed for overall administration was shorter for Ateos than FlexTouch, and time for each procedure was shorter or similar for Ateos versus FlexTouch. Ateos was easy for participants with T2DM to learn with fewer repeated steps due to procedural errors, and easy for healthcare professionals to introduce to their patients. FAU - Asakura, Toshinari AU - Asakura T AD - Faculty of Pharmaceutical Sciences, Niigata University of Pharmacy and Applied Life Sciences, Niigata, Japan. FAU - Yamazaki, Toshinobu AU - Yamazaki T AD - Faculty of Pharmaceutical Sciences, Niigata University of Pharmacy and Applied Life Sciences, Niigata, Japan. FAU - Cai, Zhihong AU - Cai Z AD - Statistical Science, Medicines Development Unit-Japan, Eli Lilly Japan K.K, Kobe, Japan. FAU - Aranishi, Toshihiko AU - Aranishi T AUID- ORCID: 0000-0001-8862-9468 AD - Health Outcomes, Health Technology Assessment, Real World Evidence, Medicines Development Unit-Japan, Eli Lilly Japan K.K., Kobe, Japan. LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20200319 PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Hypoglycemic Agents) RN - 0 (Immunoglobulin Fc Fragments) RN - 0 (Insulin, Long-Acting) RN - 0 (Recombinant Fusion Proteins) RN - 54Q18076QB (insulin degludec) RN - 62340-29-8 (Glucagon-Like Peptides) RN - WTT295HSY5 (dulaglutide) SB - IM MH - Adult MH - Aged MH - Cross-Over Studies MH - Diabetes Mellitus, Type 2/*drug therapy MH - Female MH - Glucagon-Like Peptides/administration & dosage/*analogs & derivatives MH - Humans MH - Hypoglycemic Agents/*administration & dosage MH - Immunoglobulin Fc Fragments/*administration & dosage MH - Injections MH - Insulin, Long-Acting/*administration & dosage MH - Learning MH - Male MH - Middle Aged MH - Recombinant Fusion Proteins/*administration & dosage MH - Self Administration OTO - NOTNLM OT - Type 2 diabetes mellitus OT - dulaglutide OT - insulin degludec OT - self-administration OT - self-injection EDAT- 2020/03/07 06:00 MHDA- 2021/03/12 06:00 CRDT- 2020/03/07 06:00 PHST- 2020/03/07 06:00 [pubmed] PHST- 2021/03/12 06:00 [medline] PHST- 2020/03/07 06:00 [entrez] AID - 10.1080/03007995.2020.1739636 [doi] PST - ppublish SO - Curr Med Res Opin. 2020 May;36(5):765-769. doi: 10.1080/03007995.2020.1739636. Epub 2020 Mar 19.