A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Spain

Novo Nordisk A/S1 site in 1 country465 target enrollmentJuly 28, 2022

ConditionsDiabetes Mellitus, Type 2

InterventionsSemaglutide

DrugsSemaglutide

Overview

Phase: Not Applicable
Intervention: Semaglutide
Conditions: Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Enrollment: 465
Locations: 1
Primary Endpoint: Change in HbA1c
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to collect information on participant's blood sugar levels, body weight, how satisfied participant is with the treatment, and how participant takes his/her diabetes medicines. Participant will get Rybelsus® as prescribed by 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.

Registry

clinicaltrials.gov

Start Date

July 28, 2022

End Date

July 4, 2024

Last Updated

7 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

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)
•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

Arms & Interventions

Participants with type 2 diabetes

Participants with type 2 diabetes and naive to injectable glucose-lowering treatment.

Intervention: Semaglutide

Outcomes

Primary Outcomes

Change in HbA1c

Time Frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)

Measured in percentage (%)-points

Secondary Outcomes

HbA1c < 7%(End of Study visit (V3) (week 34- 44))
HbA1c reduction >=1%-points and body weight reduction of >=3%(From baseline (week 0) to End of Study visit (V3) (week 34-44))
Relative change in body weight(From baseline (week 0) to End of Study visit (V3) (week 34-44))
Absolute change in body weight(From baseline (week 0) to End of Study visit (V3) (week 34-44))
HbA1c reduction >=1%-points and body weight reduction of >=5%(From baseline (week 0) to End of Study visit (V3) (week 34-44))
DTSQc, relative treatment satisfaction(End of Study visit (V3) (week 34- 44))
DTSQs, change in absolute treatment satisfaction(From baseline (week 0) to End of Study visit (V3) (week 34-44))