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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1235-6983 | Other Identifier | World Health Organization (WHO) |
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The study is investigating Ryzodeg®,a medication prescribed to patients with type 2 diabetes mellitus.The study is being carried out to investigate the effect of Ryzodeg® on the change of glycated haemoglobin levels and other diabetes indicators. Participants participation will not affect their medical care. In this retrospective study, the study doctor will collect data from the participants patient files available at the study site. Participants will need to sign the informed consent form during a single visit. Participants files will be reviewed and data relevant to the study will be extracted, within 26 weeks before and after Ryzodeg® treatment initiation (total of 52 weeks). Chart review for all patients is expected to take approximately 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ryzodeg® | Participants are patients with Type 2 Diabetes (T2D) treated with Ryzodeg® (Insulin Degludec/Insulin Aspart) in a real-world adult population in Lebanon |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Degludec/Insulin Aspart | Drug | All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in Lebanon. Decision to initiate treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) | Percent (%) point. For all primary and secondary outcome measures: Baseline values for effect assessment will be collected as close to and prior to Ryzodeg® initiation as possible (week 0) but none of these values may be more than 12 weeks old. For end of study a window of 6 weeks before and after week 26 is used. | From baseline (defined as the time of Ryzodeg® initiation (week -12 to week 0)) to end-of-study (week 26 +/- 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c less than 7% | Percentage of patients | At end-of-study week 26 |
| HbA1c less than 7% without any severe hypoglycaemic episodes during period 2 (26 weeks after initiation of Ryzodeg®) | Percentage of patients |
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Inclusion Criteria:
Exclusion Criteria:
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Participants are patients with Type 2 Diabetes (T2D) treated with Ryzodeg® (Insulin Degludec/Insulin Aspart) in a real-world adult population in Lebanon
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Beirut, Hamra | Beirut | 00000 | Lebanon |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C578220 | insulin degludec, insulin aspart drug combination |
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| At end-of-study week 26 |
| Change in fasting plasma glucose (FPG) | mmol/L | From baseline to end-of-study week 26 |
| Change in insulin dose (total, basal, prandial) | units/day | From baseline to end-of-study week 26 |
| Change in body weight | Kilogram (Kg) | From baseline to end-of-study week 26 |
| Change in the occurrence of severe hypoglycaemic events before and after initiation of treatment | Number of patients experiencing severe hypoglycaemic events in period 1 versus period 2. Period 1 is defined as 26 weeks prior to initiation of Ryzodeg® and period 2 is defined as 26 weeks after initiation of Ryzodeg®. | From week -26 to week 26 |
| D004700 | Endocrine System Diseases |