A Research Study to Understand How Oral Semaglutide Works in People With Type 2 Diabetes in India

NCT05502562 | Completed DMC

• 2 other identifiers: NN9924-4960U1111-1270-0826
• Study Type: observational
• Target: 388
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to look at the change in blood sugar levels in participants with type 2 diabetes who start using oral semaglutide. Participants will get oral semaglutide as prescribed to them by the study doctor. The study will last for about 8-11 months (34-44 weeks). Participants will be asked to complete a questionnaire about how they take oral semaglutide tablets. Participants will complete this questionnaire during the normal scheduled visit with the doctor and will be asked questions about their health and their diabetes treatment and lab tests as part of their normal doctor's appointment.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Glycated haemoglobin A1c (HbA1c)

  Measured as percentage (%)-points.

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

Secondary Outcomes (5)

• 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)

• Glycated haemoglobin A1c (HbA1c) less than (<) 7%

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

• HbA1c reduction greater than or equal to (>=) 1%-points and body weight reduction of greater than or equal to (>=) 5%

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

• HbA1c reduction greater than or equal to (>=) 1%-points and body weight reduction of greater than or equal to (>=) 3%

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

Study Arms (1)

Participants with type 2 diabetes

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

Drug: Oral semaglutide

Interventions

Oral semaglutide DRUG

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.

Participants with type 2 diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with type 2 diabetes and naive 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 (T2D).
• 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 glycated haemoglobin A1c (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 or equal to (\<=) 14 days.

You may not qualify if:

• Previous participation in this study. Participation is defined as having given informed consent in this study.
• Any prior or current use of oral semaglutide.
• Hypersensitivity to oral semaglutide or to any of the excipients.
• Treatment with any investigational drug within 30 days prior to signing of informed consent.
• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to signing of informed consent.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Related Publications (1)

• Sanyal D, Saboo B, Phatak SR, Kumar PKM, Basu D, Verma N, Nair A, Bhattacharjee K, Aneja P, Makkar BMM, Negalur V, Mithal A, Unnikrishnan AG. Real-World Usage of Once-Daily Oral Semaglutide in Adults with Type 2 Diabetes: Findings from PIONEER REAL India. Indian J Endocrinol Metab. 2025 Sep-Oct;29(5):523-530. doi: 10.4103/ijem.ijem_179_25. Epub 2025 Oct 25.

  PMID: 41229720 DERIVED

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: August 14, 2022
• First Posted: August 16, 2022
• Study Start: February 24, 2023
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share