Clinical Trial Details
| Trial ID: | L5227 |
| Source ID: | NCT04838743 |
| Associated Drug: | Ideglira |
| Title: | GOAL: A Research Study Looking at Long Term Blood Sugar Control in People With Type 2 Diabetes Treated With Xultophy® in Local Clinical Practice in Japan. |
| Acronym: | GOAL |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: IDegLira |
| Outcome Measures: | Primary: Change in local laboratory measured HbA1c (Glycated haemoglobin ), % point, From baseline (Visit 1) to 26 weeks (Visit 3) | Secondary: Change in local laboratory measured FPG (Fasting plasma glucose ), mg/dL, From baseline (Visit 1) to 26 weeks (Visit 3)|Number of patient-reported non-severe hypoglycaemic after initiation of treatment with Xultophy®, Count of episodes Non-severe hypoglycaemia: Defined as an episode with patient reported symptoms and/or self-measured plasma glucose value below 3.9 mmol/L (70 mg/dL). episodes, From baseline (Visit 1) to 26 weeks (Visit 3)|Number of patient-reported severe hypoglycaemic after initiation of treatment with Xultophy®, Count of episodes Severe hypoglycaemia: Defined as an episode of hypoglycaemia requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective action episodes, From baseline (Visit 1) to 26 weeks (Visit 3)|Change in concomitant OAD(s) (Oral antidiabetic drugs ) including change in number, class, and frequency of concomitant OAD(s), after initiation of treatment of Xultophy® (Yes/No), Count of patients, From baseline (Visit 1) to 26 weeks (Visit 3)|Change in daily dose of Xultophy®, Dose, From baseline (Visit 1) to 26 weeks (Visit 3) |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | |
| Enrollment: | 244 |
| Study Type: | OBSERVATIONAL |
| Study Designs: | Observational Model: |Time Perspective: p |
| Start Date: | 2021-04-23 |
| Completion Date: | 2022-10-26 |
| Results First Posted: | |
| Last Update Posted: | 2024-01-26 |
| Locations: | Seino Internal Medicine Clinic, Koriyama-shi, Fukushima, Japan, 963 8851, Japan|Naka Kinen Clinic, Naka-shi, Ibaraki, Japan, 311 0113, Japan|Tsuruma Kaneshiro Diabetes Clinic, Yamato-shi, Kanagawa, 242-0004, Japan|Jinnouchi Hospital, Kumamoto-shi, Kumamoto, Japan, 862-0976, Japan|Heiwadai Hospital, Miyazaki-shi, Miyazaki, Japan, 880-0034, Japan|Abe Diabetes Clinic_Internal Medicine, Oita-shi, Oita, Japan, 870 0039, Japan|TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology, Aichi, 468-0009, Japan|Kumanomae Nishimura Internal Medical Clinic, Arakawa-ku, Tokyo, 116-0012, Japan|Yoshida Hospital, Asahikawa-shi, Hokkaido, 070-0054, Japan|Nippon Medical School Hospital, Diabetes,Metabology,Endocrin, Bunkyo-ku, Tokyo, 113-8603, Japan|Gengendo Kimitsu Hospital, Chiba, 299-1144, Japan|The Institute of Medical Science, Asahi Life Foundation, Chuo-ku, Tokyo, 103-0002, Japan|Soyokaze CardioVascular Medicine and Diabetes Care, Ehime, 790-0026, Japan|Kawada Clinic, Gunma, 373-0036, Japan|H.E.C Science Clinic, Kanagawa, 235-0045, Japan|Chigasaki Municipal Hospital, Kanagawa, 253-0042, Japan|Hotaruno hakuyukai Medical Corporation of Japan, Kisarazu-shi, Chiba, 292-0038, Japan|Gendai Clinic, Kitakyusyu-shi, Fukuoka, 802-0974, Japan|Ohisama Clinic, Kochi-shi, Kochi, 780-0082, Japan|Kawasaki Medical School Hospital, Diabetes, Endo and Metabo, Kurashiki-shi, Okayama, 701-0192, Japan|The Jikei Medical University Hospital, Minato-ku, 105-8471, Japan|Oita Endocrinology Diabetes Clinic, Oita-shi, Oita, 8700831, Japan|Okamoto Clinic for Diabetes and Endocrinology, Oita, 879-7301, Japan|Takagi hospital, Internal Medicine, Okawa-shi, Fukuoka, 831-0016, Japan|Nakajima Diabetes Clinic, Osaka-shi, 553-0023, Japan|Matsuda Gastroenterology and Diabetes Clinic, Osaka, 591-8006, Japan|Budounoki Clinic, Saga-shi, Saga, 8400054, Japan|Suruga Clinic, Shizuoka-shi, Shizuoka, 424-0853, Japan|Japanese Red Cross Shizuoka Hospital, Shizuoka, 420-0853, Japan|Oyama East Clinic, Tochigi, 323-0022, Japan |
| URL: | https://clinicaltrials.gov/show/NCT04838743 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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