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| ID | Type | Description | Link |
|---|---|---|---|
| 1111-1211-7084 | Other Identifier | World Health Organization |
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The aim of this study is to assess the safety and effectiveness of Xultophy® initiated according to label in adults with type 2 diabetes mellitus (T2DM) under routine clinical practice conditions. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xultophy® | Korean adults with type 2 diabetes mellitus (T2DM) initiating Xultophy® under routine clinical practice and according to approved label in Korea. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xultophy® (insulin degludec/liraglutide) | Drug | Xultophy® is a fixed ratio combination of the long-acting basal insulin, insulin degludec, and the glucagon-like peptide 1 receptor agonist (GLP-1 RA), liraglutide, administered under the skin. Patients will be treated according to routine clinical practice at the discretion of the treating physician according to the label approved by MFDS. The assignment of the patient to Xultophy® is not decided in advance by the protocol but falls within current practice and the prescription of Xultophy® is clearly separated from the decision to include the patient in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) by preferred term | Count of events | baseline (Visit1, 0 week) to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia | Plasma Glucose (PG) less than 54 mg/dL (3.0 mmol/L) | Visit1 (0 week) to 26 weeks |
| Change in body weight | Kilograms |
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Inclusion Criteria:
Exclusion Criteria:
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Korean adults with type 2 diabetes mellitus (T2DM) initiating Xultophy® under routine clinical practice and according to approved label in Korea.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 1452 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daejeon Endo Internal Medicine Clinic | Daejeon | Cheongsa-ro, Seo-gu | 35220 | South Korea | ||
| Soon Chun Hyang University Hospital Cheonan |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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|
|
| Visit 1 (0 week), Visit 3 (13 weeks) |
| Change in body weight | kilograms | Visit 1 (0 week), Visit 4 (26 weeks) |
| Change of Xultophy® dose | Units | Visit 1 (0 week), 13 weeks (Visit 3) |
| Change of Xultophy® dose | Units | Visit (0 week), Visit 4 (26 weeks) |
| Change in Glycosylated Haemoglobin (HbA1c) | Percentage | Visit 1 (0 week), Visit 3 (13 weeks) |
| Change in HbA1c | Percentage | Visit 1 (0 week), Visit 4 (26 weeks) |
| Individuals achieving HbA1c target less than 7.0 % | Percentage | Visit 1 (0 week), Visit 3 (13 weeks) |
| Individuals achieving HbA1c target less than 7.0 % | Percentage | Visit 1 (0 week), Visit 4 (26 weeks) |
| Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) | mg/dl | Visit 1 (0 week), Visit 3 (13 weeks) |
| Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) | mg/dl | Visit 1 (0 week), Visit 4 (26 weeks) |
| Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) | mg/dl | Visit 1 (0 week), Visit 3 (13 weeks) |
| Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) | mg/dl | Visit 1 (0 week), Visit 3 (26 weeks) |
| Cheonan |
| Chungcheongnam-do |
| 31151 |
| South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| The Catholic University of Korea, ST. Vincent's Hospital | Suwon | Gyeonggi-do | 16247 | South Korea |
| Jeonbuk National University Hospital | Jeonju | Jeollabuk-do | 54907 | South Korea |
| Isam Hospital | Busan | 47354 | South Korea |
| Inje University Busan Paik Hospital | Busan | 47392 | South Korea |
| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 42601 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 42601 | South Korea |
| Eulji University Hospital_Daejeon | Daejeon | 302-120 | South Korea |
| Daejeon Endo Internal Medicine Clinic | Daejeon | 35220 | South Korea |
| Chungbuk National University Hospital | Daejeon | 361-711 | South Korea |
| Dongguk University Ilsan Hospital | Goyang | 10326 | South Korea |
| Hyewon Medical Foundation Sejong General Hospital | Gyeonggi-do | 14754 | South Korea |
| Ajou University Hospital | Gyeonggi-do | 16499 | South Korea |
| Dongtan Jeil Women's Hospital | Gyeonggi-do | 18450 | South Korea |
| Gyeongsang National University Hospital | Gyeongsangnam-do | 52727 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Hanil General Hospital | Seoul | 01450 | South Korea |
| Nowon Eulji Medical Center, Eulji University | Seoul | 01830 | South Korea |
| Sahm Yook Medical Center | Seoul | 02500 | South Korea |
| Yonsei Leehyunchul Internal Medicine | Seoul | 04058 | South Korea |
| Inje University Seoul Paik Hospital | Seoul | 04551 | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | 05278 | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | 06591 | South Korea |
| The Catholic University of Korea, Yeouido ST. Mary's Hospital | Seoul | 07345 | South Korea |
| KangNam Sacred Heart Hospital | Seoul | 07441 | South Korea |
| Jae Clinic | Seoul | 08226 | South Korea |
| Uijeongbu Eulji university Hospital | Uijeongbu-si | 11759 | South Korea |
| Ulsan Hospital | Ulsan | 44686 | South Korea |
| Ulsan University Hospital | Ulsan | 682-060 | South Korea |
| 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 |
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| ID | Term |
|---|---|
| C000629636 | Xultophy |
| C571886 | insulin degludec |
| D000069450 | Liraglutide |
| C000613158 | IDegLira |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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