Clinical trial NCT06507475: Real World Effectiveness of Oral Semaglutide in Thailand Participants With Type 2 Diabetes
Official title: Real World Effectiveness of Oral Semaglutide in Thailand Patients With Type 2 Diabetes: an Observational, Multicentre, Retrospective Cohort Study REAL-world Effectiveness of Oral Semaglutide In a Cohort of Thai patientS With Type 2 Diabetes treatED With Oral Antidiabetic Medications (REALISED) Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with type 2 diabetes (T2D) who had initiated once-daily oral semaglutide during the target selection period of April 2022 to December 2023 and have not previously been treated with injectable glucose-lowering medication in routine clinical practice.

Brief summary: This study aims to describe the effectiveness of oral semaglutide on glycemic control and body weight control and describe characteristics of type 2 diabetes (T2D) adult patients who are being treated with oral semaglutide in Thailand. Data of eligible patients with T2D will be collected via electronic medical record or paper-format chart review to assess the effectiveness of oral semaglutide. Total study duration for the individual patient will be six months from baseline. The study duration expands within the window period will be 12 months from baseline which will be the optional visit.


Eligibility criteria: Inclusion Criteria:

* Adult Thai male or female patients aged greater than or equal to (≥) 18 years.
* Diagnosed with T2D either through International Classification of Diseases (ICD) code or by physician's description such as documentation in the medical record, and who have not previously been treated with injectable glucose-lowering medication.
* At least one recent or closest Glycated Haemoglobin (HbA1c) test value available and documented less than or equal to 12 weeks prior to the initiation of oral semaglutide.
* Had initiated oral semaglutide for diabetes during the target selection period of April 2022 to December 2023. All required data for collection should already be accessible prior to the initiation of data collection.
* Treated with oral semaglutide for at least 6 months without interruption or discontinuation.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study (if applicable).
* Participants with any diagnosis of type 1 diabetes (T1D).
* Medical records documenting prior or ongoing treatment with injectable glucose-lowering treatment.

Primary outcomes:
measure: Change in Glycated Haemoglobin (HbA1c)
timeFrame: Baseline (week 0), end of study (week 26)
Secondary outcomes:
measure: Absolute Change in Body Weight
timeFrame: At or within 12 months prior to baseline (week 0), end of study (week 26)
measure: Relative Change in Body Weight
timeFrame: At or within 12 months prior to baseline (week 0), end of study (week 26)
measure: Age of Participants
timeFrame: At baseline (week 0)
measure: Percentage of Participants Assessed for Age
timeFrame: At baseline (week 0)
measure: Number of Participants Assessed for Gender (Male/Female)
timeFrame: At baseline (week 0)
measure: Percentage of Participants With Smoking History (Never, Previous, Current)
timeFrame: At baseline (week 0)
measure: Diabetes Duration of Participants
timeFrame: At baseline (week 0)
measure: Percentage of Participants With Reasons to Initiate Oral Semaglutide Treatment
timeFrame: At baseline (week 0)
measure: Body Weight
timeFrame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
measure: Diabetes Related Co-morbidities (modified Charlson Comorbidity Index [mCCI] Category)
timeFrame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
measure: Fasting Plasma Glucose
timeFrame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
measure: Post Prandial Glucose
timeFrame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
measure: Diabetes Medications: Type of Drugs Class
timeFrame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
measure: Diabetes Medications: Number
timeFrame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
measure: Diabetes Medications: Dosage
timeFrame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
measure: Waist Circumference
timeFrame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
measure: Body Mass Index
timeFrame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
measure: Blood Pressure (systolic/diastolic)
timeFrame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
measure: Creatinine
timeFrame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
measure: Lipid profile: Low-density Lipoprotein Cholesterol (LDL), Non-high-density Lipoprotein Cholesterol (non-HDL), High-density Lipoprotein Cholesterol (HDL), Very Low Density Lipoprotein (VLDL), Total Cholesterol and Triglycerides
timeFrame: At or within 12 months prior to baseline (week 0) to optional visit (week 52-62)
measure: Percentage of Participants Achieveing Glycated Haemoglobin (HbA1c) Less Than 7 Percentage (%)
timeFrame: At or within 12 months prior to baseline (week 0), end of study (week 26) and optional visit (week 52-62)
Other outcomes:
Locations:
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: