A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice

NCT05473286 | Withdrawn FDA Drug

• 1 other identifier: NN9924-4540
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 34-44 weeks. Participants will be asked to complete questionnaires about how they take their Rybelsus® tablets. Participants will complete the questionnaires during their normally scheduled visit with the study doctor.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Glycated haemoglobin (HbA1c )

  Percent-points.

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

Secondary Outcomes (7)

• 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 <7% (Yes or No)

  End of Study visit (V3) (week 34-44)

• HbA1c reduction >=1%-points and body weight reduction of >=5% (Yes/No)

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

• HbA1c reduction >=1%-points and body weight reduction of >=3% (Yes/No)

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

Study Arms (1)

Patients with type 2 diabetes

Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.

Drug: Oral Semaglutide

Interventions

Oral Semaglutide DRUG

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. 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.

Patients with type 2 diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.

You may qualify if:

• 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 naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than (\<) 14 days.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 25, 2022
• Study Start: September 30, 2022
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share