Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1253-2025 | Other Identifier | World Health Organization (WHO) | |
| jRCT1051210008 | Registry Identifier | JAPIC (Japan) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to collect information on how Xultophy® works with other oral anti diabetic medication in patients with type 2 diabetes.
Participants will get Xultophy® as prescribed by the study doctor. The study will last for about 26 weeks. Participants will be asked questions about health and diabetes treatment and lab tests as part of normal doctor's appointment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDegLira | Real-world adult population with type 2 diabetes mellitus in Japan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDegLira | Drug | Patients will be treated with commercially available Xultophy® (IDegLira) in a pre-filled pen injector (FlexTouch®) at the discretion of the treating physician in accordance with the Xultophy® label in Japan. The decision to initiate treatment with Xultophy® is at the treating physician's discretion according to the approved Xultophy® label in Japan and independent from the decision to include the patient in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in local laboratory measured HbA1c (Glycated haemoglobin ) | % point | From baseline (Visit 1) to 26 weeks (Visit 3) |
| Measure | Description | Time Frame |
|---|---|---|
| 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® |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Real-world adult population with type 2 diabetes mellitus in Japan
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seino Internal Medicine Clinic_Internal medicine | Koriyama-shi | Fukushima, Japan | 963 8851 | Japan | ||
| Naka Kinen Clinic_Internal medicine |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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) |
| Naka |
| Ibaraki, Japan |
| 311 0113 |
| Japan |
| Tsuruma Kaneshiro Diabetes Clinic_Internal medicine | Yamato-shi | Kanagawa | 242-0004 | Japan |
| Jinnouchi Hospital_Internal Medicine | Kumamoto | Kumamoto, Japan | 862-0976 | Japan |
| Heiwadai Hospital_Internal Medicine | Miyazaki | Miyazaki | 880-0034 | Japan |
| Abe Diabetes Clinic_Internal Medicine | Ōita | Oita, Japan | 870 0039 | Japan |
| Asano Clinic | Kawagoe-shi | Saitama, Japan | 350-0851 | Japan |
| TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology | Aichi | 468-0009 | Japan |
| Kumanomae Nishimura Naika Clinic_Internal Medicine | 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_Diabetes and Endocrinology | Chiba | 299-1144 | Japan |
| Akaicho Clinic | Chiba-shi, Chiba | 260-0804 | Japan |
| The Institute of Medical Science, Asahi Life Foundation_Internal Medicine | Chuo-ku, Tokyo | 103-0002 | Japan |
| Soyokaze CardioVascular Medicine and Diabetes Care | Ehime | 790-0026 | Japan |
| Futata Tetsuhiro Clinic Meinohama_Internal medicine | Fukuoka-shi, Fukuoka | 819-0006 | Japan |
| Kawada Clinic | Gunma | 373-0036 | Japan |
| H.E.C Science Clinic | Kanagawa | 235-0045 | Japan |
| Chigasaki Municipal Hospital_Endocrinology and Metabolism | 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_Diabetes, Metabolism and Endo. | Minatoku | 105-8471 | Japan |
| Nakayama Clinic_Nagoya-shi, Aichi | Nagoya-shi, Aichi | 456-0058 | Japan |
| Abies Kanno Clinic | Numakunai | 021-0002 | Japan |
| Sumi Clinic | Oita-shi, Oita | 870-0955 | Japan |
| Oita Endocrinology Diabetes Clinic | Oita-shi, Oita | 8700831 | Japan |
| Takagi hospital, Internal Medicine | Okawa-shi, Fukuoka | 831-0016 | Japan |
| Kansai Electric Power Hospital_Center for Diabetes | Osaka | 553-0003 | Japan |
| Nakajima Diabetes Clinic | Osaka | 553-0023 | Japan |
| Matsuda Gastroenterology and Diabetes Clinic | Osaka | 591-8006 | Japan |
| Okamoto Clinic for Diabetes and Endocrinology | Ōita | 879-7301 | Japan |
| Budounoki Clinic | Saga-shi, Saga | 8400054 | Japan |
| Japan Red Cross Shizuoka Hospital_Diabetes and Endocrinology | Shizuoka | 420-0853 | Japan |
| Suruga Clinic | Shizuoka-shi, Shizuoka | 424-0853 | Japan |
| Soka Sugiura Internal Medicine Clinic | Soka-shi, Saitama | 340-0015 | Japan |
| Higashi Diabetes and Cardiovascular Clinic, Internal | Tamana-shi, Kumamoto | 865 0016 | Japan |
| Oyama East Clinic_Internal Medicine | Tochigi | 323-0022 | Japan |
| Clinic Mirai Tachikawa | Tokyo | 190-0023 | Japan |
| Tamacenter Clinic Mirai | Tokyo | 206-0033 | Japan |
| Seishinkai Okamoto Naika Iin | Yaizu-shi, Shizuoka | 425-0022 | Japan |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613158 | IDegLira |
Not provided
Not provided
Not provided