Clinical trial NCT06269120: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-02-21
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participant diagnosed with T2D and without any prior or current use of oral semaglutide.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5%
timeFrame: From Baseline to end of study (week 32)
Secondary outcomes:
measure: Change in HbA1c
timeFrame: From Baseline to end of study (week 32)
measure: Change in fasting plasm glucose (FPG)
timeFrame: From Baseline to end of study (week 32)
measure: Absolute change in body weight (BW)
timeFrame: From Baseline to end of study (week 32)
measure: Relative change in BW
timeFrame: From Baseline to end of study (week 32)
measure: HbA1c less than (<) 7.0%
timeFrame: At end of study (week 32)
measure: HbA1c <6.5%
timeFrame: At end of study (week 32)
measure: Body weight reduction ≥5%
timeFrame: At end of study (week 32)
measure: HbA1c reduction ≥1%-point and BW reduction ≥5%
timeFrame: From Baseline to end of study (week 32)
measure: HbA1c reduction ≥1%-point and BW reduction ≥3%
timeFrame: From Baseline to end of study (week 32)
measure: Change in waist circumference
timeFrame: From Baseline to end of study (week 32)
measure: Change in blood pressure (BP) (systolic and diastolic)
timeFrame: From Baseline to end of study (week 32)
measure: Change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides [TG])
timeFrame: From Baseline to end of study (week 32)
measure: Change in high sensitive C-reactive protein (hsCRP)
timeFrame: From Baseline to end of study (week 32)
Other outcomes:
Locations:
city: Siklós
country: Hungary
facility: Siklósi Kórház, Diabetológia
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: