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Completed

NCT Number: NCT05716724

O-SEMA-Fast: A Research Study to Understand How Oral Semaglutide Works in People With Type 2 Diabetes Who Plan to Fast During Ramadan in the United Arab Emirates, Saudi Arabia, and Kuwait

The purpose of the study is to look at the change in blood sugar levels in people with type 2 diabetes who are using oral semaglutide and planning to fast during Ramadan. Participants will take oral semaglutide as prescribed by the study doctor. The study will last for about 5 months (20 weeks). Participants will be asked to complete a patient diary about how and when they take the oral semaglutide tablets. Participants will complete this diary during the study period as instructed by study doctor.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

KOC Hospital, Al Ahmadi, Kuwait

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician 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
  • Patients diagnosed with T2D who intend to fast during Ramadan
  • Patient should be on oral semaglutide (at least 4 weeks on maintenance dose) with or without other OADs
  • Available HbA1c value ≤ 30 days prior to the patient enrolment visit (V1) or HbA1c measurement taken in relation with the patient enrolment visit (V1) if in line with local clinical practice

Exclusion criteria

  • Previous participation in this study. Participation is defined as having given informed consent in this study
  • Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to the patient enrolment visit (V1) and throughout the duration of the study
  • Patients with type-1 diabetes and gestational diabetes
  • Patients who are pregnant or are planning to become pregnant during the conduct of the study
  • Patients who are breastfeeding
  • Patients on Insulin therapy within 2 weeks prior to enrolment
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Treatment and study plan

semaglutide

Drug

Participants will receive oral semaglutide with or without other OADs as per local label at the discretion of the treating physician and is clearly independent from the decision to include the participant in the study.

Primary outcomes

  1. Change in glycated haemoglobin (HbA1c)

    Time frame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)

    Percentage (%) of HbA1c.

Secondary outcomes

  1. Relative change in body weight

    Time frame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)

    Measured in percentage.

  2. Absolute change in body weight

    Time frame: From participant enrolment visit (0 to 8 weeks before Ramadan) to End of follow-up visit (0 to 8 weeks after Ramadan)

    Measured in kilogram (kg).

  3. Self-reported confirmed hypoglycaemic events

    Time frame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)

    Measured in count of events.

  4. Self-reported hyperglycaemic episodes requiring hospitalisation

    Time frame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)

    Measured in count of episodes.

  5. Number of participants reporting greater than or equal to (>= 1) severe hypoglycaemic events

    Time frame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)

    Measured in count of participants.

  6. Number of self-reported gastrointestinal (GI) side-effects

    Time frame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)

    Measured in count of events.

  7. Addition of new OAD or increased baseline OAD dose during the study period

    Time frame: At end of follow-up visit (0 to 8 weeks after Ramadan)

    Measured in count of participants (yes or no).

  8. Removal of OAD or reduction of baseline OAD dose during the study period

    Time frame: At end of follow-up visit (0 to 8 weeks after Ramadan)

    Measured in count of participants (yes or no).

  9. Increase in dose of oral semaglutide

    Time frame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)

    Measured in count of participants (yes or no).

  10. Decrease in dose of oral semaglutide

    Time frame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)

    Measured in count of participants (yes or no).

  11. Waiting time of at least 30 min after intake of oral semaglutide and before eating or drinking or taking any other oral medicinal product as per local label and as reported in patient diary

    Time frame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)

    Measured in count of participants (yes or no).

  12. Intake of oral semaglutide with up to 120 milliliter (mL) of water as reported in patient diary

    Time frame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)

    Measured in count of participants (yes or no).

  13. Timing of intake of oral semaglutide as reported in patient diary

    Time frame: From participant enrolment visit (0 to 8 weeks before Ramadan) to end of follow-up visit (0 to 8 weeks after Ramadan)

    Time before iftar (before iftar is before breaking the fast)/time before suhour (before suhour is before the last meal)/others.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Prospective, Non-interventional Study, Investigating Glycaemic Control and Treatment Patterns Associated With the Use of Once-daily Oral Semaglutide in Type 2 Diabetes Patients Who Intend to Fast During Ramadan in the United Arab Emirates, Saudi Arabia, and Kuwait

Acronym: O-SEMA-Fast

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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