SEMA-CardioDiab HUNGARY: A Research Study to Understand the Effects of Oral Semaglutide on Blood Sugar Levels, Weight, and Cardiovascular Risk in People With Type 2 Diabetes Patients in Hungary

Type 2 Diabetes Clinical Trial

Official title:

SEMA-CardioDiab HUNGARY: A Multicentre, Prospective, Non-interventional Study to Evaluate Glycemic Control and Weight Changes in Patients With Type 2 Diabetes Initiating Treatment With Oral Semaglutide by Cardiologists or Diabetologists as Part of Local Clinical Practice in Hungary

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06269120
• Other study ID #: NN9924-7787
• Secondary ID: U1111-1290-8109
• Status: Not yet recruiting
• Start date: February 15, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Participant will get oral semaglutde as prescribed by the study doctor. The study will last for about 26 ± 4 weeks (5 to 7 months). Participant will be asked to complete a questionnaire about how they take oral semaglutide tablets during normal scheduled visit with doctor. Participant will also be asked questions about health and their diabetes treatment and lab tests as part of normal doctor's appointment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 470
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).

• The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/LAR and the treating physician based on local label before and independently from the decision to include the patient in this study.

• Male or female, adults above or equal to 18 years of age at the time of signing informed consent.

• Diagnosed with type 2 diabetes mellitus.

• Patient on metformin (Met) with or without modern oral antidiabetic (MOAD, that is Dipeptidyl Peptidase-4 Inhibitor [DPP4i] or/and Sodium-glucose cotransporter-2 Inhibitor [SGLT2i]) with or without insulin therapy.

• Available HbA1c value > 7.0% within 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice.

Exclusion Criteria:

• Previous participation in this study (defined as having given informed consent in this study earlier).

• Treatment with any investigational drug within 30 days prior to enrolment into the study.

• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

• Glucagon like peptide -1 receptor agonist (GLP1-RA) treatment within 90 days prior to the Treatment Initiation visit (V1).

• Patients diagnosed with type 1 diabetes mellitus.

• Female who is known to be pregnant, undergoing fertility treatment, breastfeeding or intends to become pregnant during the study duration.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Oral Semaglutide
Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated haemoglobin (HbA1c ) reduction greater than or equal to (=) 0.5%-point and body weight reduction = 5%	Participants (yes/no).	From Baseline to end of study (week 32)
Secondary	Change in HbA1c	Measured in percentage (%)- point.	From Baseline to end of study (week 32)
Secondary	Change in fasting plasm glucose (FPG)	Measured in millimoles per liter (mmol/l).	From Baseline to end of study (week 32)
Secondary	Absolute change in body weight (BW)	Measured in kilogram (kg).	From Baseline to end of study (week 32)
Secondary	Relative change in BW	Measured in %.	From Baseline to end of study (week 32)
Secondary	HbA1c less than (<) 7.0%	Participants (yes/no).	At end of study (week 32)
Secondary	HbA1c <6.5%	Participants (yes/no).	At end of study (week 32)
Secondary	Body weight reduction =5%	Participants (yes/no).	At end of study (week 32)
Secondary	HbA1c reduction =1%-point and BW reduction =5%	Participants (yes/no).	From Baseline to end of study (week 32)
Secondary	HbA1c reduction =1%-point and BW reduction =3%	Participants (yes/no).	From Baseline to end of study (week 32)
Secondary	Change in waist circumference	Measured in centimeter (cm).	From Baseline to end of study (week 32)
Secondary	Change in blood pressure (BP) (systolic and diastolic)	Measured in millimeter of mercury (mmHg).	From Baseline to end of study (week 32)
Secondary	Change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides [TG])	Measured in mmol/L.	From Baseline to end of study (week 32)
Secondary	Change in high sensitive C-reactive protein (hsCRP)	Measured in milligram per liter (mg/l).	From Baseline to end of study (week 32)