A research study to understand how oral semaglutide works in people with type 2 diabetes in India
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2023/02/049724
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Signed consent obtained before any study-related activities (study-related activities are any
procedure related to recording of data according to the protocol).
2. Diagnosed with T2D.
3. 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.
4. Male or female, age above or equal to 18 years at the time of signing informed consent.
5. Available HbA1c value = 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.
6. Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin
treatment for acute illness for a total of < 14 days.
1. Previous participation in this study. Participation is defined as having given informed consent in this study.
2. Any prior or current use of oral semaglutide.
3. Hypersensitivity to oral semaglutide or to any of the excipients.
4. Treatment with any investigational drug within 30 days prior to signing of informed consent.
5. Participation in any clinical trial of an approved or non-approved investigational medicinal
product within 30 days prior to signing of informed consent.
6. Mental incapacity, unwillingness or language barriers precluding adequate understanding or
cooperation.
Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of coronavirus disease 2019 (COVID-19) or post-infectious conditions is allowed if the last dose of the investigational
medicinal product has been received more than 30 days prior to signing of informed consent
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the glycaemic control in adult <br/ ><br>patients with type 2 diabetes (T2D) who have not previously been treated with injectable glucose-lowering medication and who initiate treatment with oral semaglutide.Timepoint: From baseline End of study (V3)
- Secondary Outcome Measures
Name Time Method HbA1c less than 7% at End of Study visit (V3)Timepoint: End of study visit (V3);To investigate mean changes in body <br/ ><br>weight in adult patients with T2D who have not previously been treated with injectable glucose-lowering medication and who initiate treatment with oral semaglutide.Timepoint: From baseline End of study (V3)