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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05443191
Other study ID # NN9924-4541
Secondary ID U1111-1240-3808
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 20, 2022
Est. completion date September 2, 2024

Study information

Verified date May 2024
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 194
Est. completion date September 2, 2024
Est. primary completion date September 2, 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) - Diagnosed with type 2 diabetes mellitus - The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (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, age above or equal to 18 years at the time of signing informed consent - Available HbA1c value less than or equal to 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 - Treatment naive to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than 14 days Exclusion Criteria: - Previous participation in this study. Participation is defined as having given informed consent in this study - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Semaglutide
Participants will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the participant in this study.

Locations

Country Name City State
Finland Aava Lääkärikeskus - Aava Kamppi, Annankatu 32, 00100 Helsinki, Finland Helsinki,
France Master centre for France_Paris La défense cedex Paris La Défense

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Finland,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Glycated haemoglobin (HbA1c ) Measured in percentage (%)-points From baseline (week 0) to End of Study visit (V3) (week 34-44)
Secondary Relative change in body weight Measured in percentage (%) From baseline (week 0) to End of Study visit (V3) (week 34-44)
Secondary Absolute change in body weight Measured in Kilogram (Kg) From baseline (week 0) to End of Study visit (V3) (week 34-44)
Secondary HbA1c < 7% Measured as Yes or No End of Study visit (V3) (week 34-44)
Secondary HbA1c reduction >=1%-points and body weight reduction of >=5% Measured as Yes or No From baseline (week 0) to End of Study visit (V3) (week 34-44)
Secondary HbA1c reduction >=1%-points and body weight reduction of >=3% Measured as Yes or No From baseline (week 0) to End of Study visit (V3) (week 34-44)
Secondary DTSQc, relative treatment satisfaction Measured in Total score End of Study visit (V3) (week 34- 44)
Secondary DTSQs, change in absolute treatment satisfaction Measured in Total score From baseline (week 0) to End of Study visit (V3) (week 34-44)
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