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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1273-4429 | Other Identifier | World Health Organization (WHO) |
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The purpose of this study is to investigate glycaemic control and other clinical parameters in glucagon like peptide -1 (GLP-1) naive adult participants with type 2 diabetes (T2D) who initiated once weekly (OW) semaglutide in local clinical practice in North Macedonia. The participants were treated according to current clinical practice, applicable local labels, and standard of care as per physicians' discretion. The total duration of the study is planned to be approximately 30 weeks which is the period from OW semaglutide initiation to end of follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucagon like peptide-1 (GLP-1) naive participants with Type 2 Diabetes (T2D) | Glucagon like peptide-1 (GLP-1) naive adult type 2 diabetes (T2D) participants who initiated once weekly (OW) semaglutide were treated according to current clinical practice, applicable local labels, and standard of care as per physicians' discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Participants who initiated once weekly (OW) semaglutide in routine clinical practice in were enrolled in the study. The participants were treated according to current clinical practice, applicable local labels, and standard of care as per physicians' discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | Measured as percentage (%) point. | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Measured in kilograms (kg). | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) |
| Change in body weight | Measured as percentage (%). |
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Inclusion Criteria:
Exclusion Criteria:
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Glucagon like peptide-1 (GLP-1) naive adult type 2 diabetes (T2D) participants who initiated once weekly (OW) semaglutide were treated according to current clinical practice, applicable local labels, and standard of care as per physicians' discretion.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Bitola | 7000 | North Macedonia | |||
| Novo Nordisk Investigational Site |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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|
| From baseline (week 0) to end of follow-up (week 30+- 4 weeks) |
| Change in waist circumference | Measured in centimeter (cm). | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) |
| Change in fasting plasma glucose (FPG) | Measured in millimoles per liter (mmol/l). | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) |
| Change in Lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides) | Measured in millimoles per liter (mmol/L). | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) |
| Change in Blood Pressure (systolic and diastolic) | Measured in millimiters of mercury (mmHg). | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) |
| Glycated haemoglobin (HbA1c) less than 7% | Measured as Yes/No. | At end of follow-up (week 30 +- 4 weeks) |
| Reduction in glycated haemoglobin (HbA1c) greater than or equal to (>=) 1% | Measured as Yes/No. | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) |
| Weight loss >= 5% | Measured as Yes/No. | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) |
| Weight loss >= 3% | Measured as Yes/No. | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) |
| HbA1c reduction >= 1% and weight loss of >=3% | Measured as Yes/No. | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) |
| Having at least 1 severe hypoglycaemic episode | Measured as Yes/No. | At end of follow-up (week 30 +- 4 weeks) |
| Debar |
| 1250 |
| North Macedonia |
| Novo Nordisk Investigational Site | General Hospital Kavadarci | 1430 | North Macedonia |
| Novo Nordisk Investigational Site | Gostivar | 1230 | North Macedonia |
| Novo Nordisk Investigational Site | Kicevo | 6250 | North Macedonia |
| Novo Nordisk Investigational Site | Kočani | 2300 | North Macedonia |
| Novo Nordisk Investigational Site | Kumanovo | 1300 | North Macedonia |
| Novo Nordisk Investigational Site | Ohrid | 6000 | North Macedonia |
| Novo Nordisk Investigational Site | Prilep | 7500 | North Macedonia |
| Novo Nordisk Investigational Site | Shtip | 2000 | North Macedonia |
| Novo Nordisk Investigational Site | Skopje | 1 000 | North Macedonia |
| Novo Nordisk Investigational Site | Skopje | 1000 | North Macedonia |
| Novo Nordisk Investigational Site | Skopje | SK 1000 | North Macedonia |
| Novo Nordisk Investigational Site | Struga | 6330 | North Macedonia |
| Novo Nordisk Investigational Site | Stumica | 2400 | North Macedonia |
| Novo Nordisk Investigational Site | Tetovo | 1220 | North Macedonia |
| Novo Nordisk Investigational Site | Veles | 1400 | North Macedonia |
| 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 |
|---|---|
| C000591245 | semaglutide |
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