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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1271-8967 | Other Identifier | World Health Organization (WHO) |
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Sponsor decision
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The purpose of this study is to look at the blood sugar control in participants with type 2 diabetes previously treated with premix insulins and initiating treatment with IDegLira. Participants will get IDegLira as prescribed by study doctor regardless of participant's decision to participate in the study. Decision to initiate treatment with IDegLira will be made by study doctor independent from the study. The study will last for about 36 weeks. Participants will be asked questions about their health and diabetes treatment and lab tests as part of their normal doctor's appointment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with type 2 diabetes (T2D) | Participants with T2D previously treated with premix insulin for at least 12 weeks (3 months) based on local clinical guidelines will initiate treatment with IDegLira at the treating physician's discretion according to the approved IDegLira label in Croatia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDegLira | Drug | Participants will be treated with IDegLira at the treating physician's discretion according to the approved IDegLira label in Croatia and independent from the decision to include the participant in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated Haemoglobin A1c (HbA1c) | Measured in percentage (%) point. | From baseline to end of study (week 36 ± 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with HbA1c less than (<) 7.0% | Number of participants having Yes/No. | At end of study (week 36 ± 6 weeks) |
| Starting dose of IDegLira | Measured in dose steps/day. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with Type 2 Diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| At baseline |
| Dose of IDegLira at end of study | Measured in dose steps/day. | At end of study (week 36 ± 6 weeks) |
| Change in body weight | Measured in kilograms (kg). | From baseline to end of study (week 36 ± 6 weeks) |
| 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 |
|---|---|
| C000613158 | IDegLira |
| C000629636 | Xultophy |
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