Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGSemaglutide
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.
Sponsors
Novo Nordisk A/S
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Male or female, age above or equal to 18 years at the time of once weekly (OW) semaglutide initiation. * The decision to initiate treatment with commercially available OW semaglutide has been made by the participant and the treating physician before and independently from the decision to include the participant in this study. * Adult participants with type 2 diabetes (T2D) initiated with OW semaglutide at least 30 +- 4 weeks prior to data collection. * Participants should have baseline glycated haemoglobin (HbA1c) measurement and at least one HbA1c measurement after baseline. For baseline HbA1c measurement, the most recent value less than 12 weeks prior to OW semaglutide initiation will be used.
Exclusion criteria
* Previous participation in this study. * Prior use of GLP-1 within last one year. * Participants with type-1 diabetes and gestational diabetes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) | Measured as percentage (%) point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in waist circumference | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) | Measured in centimeter (cm). |
| Change in fasting plasma glucose (FPG) | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) | Measured in millimoles per liter (mmol/l). |
| Change in Lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides) | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) | Measured in millimoles per liter (mmol/L). |
| Change in Blood Pressure (systolic and diastolic) | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) | Measured in millimiters of mercury (mmHg). |
| Glycated haemoglobin (HbA1c) less than 7% | At end of follow-up (week 30 +- 4 weeks) | Measured as Yes/No. |
| Change in body weight | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) | Measured in kilograms (kg). |
| Weight loss >= 5% | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) | Measured as Yes/No. |
| Weight loss >= 3% | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) | Measured as Yes/No. |
| HbA1c reduction >= 1% and weight loss of >=3% | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) | Measured as Yes/No. |
| Having at least 1 severe hypoglycaemic episode | At end of follow-up (week 30 +- 4 weeks) | Measured as Yes/No. |
| Reduction in glycated haemoglobin (HbA1c) greater than or equal to (>=) 1% | From baseline (week 0) to end of follow-up (week 30+- 4 weeks) | Measured as Yes/No. |
Countries
North Macedonia
Outcome results
None listed