Status:
ACTIVE_NOT_RECRUITING
Comparison of Once-Weekly Trelagliptin vs. Once-Daily Vildagliptin for HbA1c Reduction in Type 2 Diabetes
Lead Sponsor:
PNS Hafeez - Naval Hospital
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
30-60 years
Phase:
NA
Brief Summary
This randomized controlled trial evaluated the efficacy of once-weekly trelagliptin compared to once-daily vildagliptin in reducing HbA1c levels in patients with type 2 diabetes mellitus (T2DM). A tot...
Detailed Description
Before the commencement of the study, ethical approval was obtained from the Institutional Review Board of the hospital. All study procedures adhered strictly to the ethical guidelines of both institu...
Eligibility Criteria
Inclusion
- Adults aged 30-60 years.
- Both male and female.
- Diagnosed with type 2 diabetes mellitus.
- HbA1c levels between 7.5% and 9.5% at screening.
- Able to provide informed consent.
Exclusion
- Type 1 diabetes mellitus or a history of ketoacidosis.
- Use of insulin or any antidiabetic drugs other than metformin within 3 months prior to the start of the study.
- Significant cardiovascular disease, including recent myocardial infarction (within the last 6 months), unstable angina, or uncontrolled hypertension.
- Chronic kidney disease (stage 3 or worse) or hepatic or pancreatic dysfunction.
- Pregnant or breastfeeding or planning to become pregnant during the study duration.
- Participation in another clinical trial within 30 days prior to enrollment.
- Known hypersensitivity to trelagliptin, vildagliptin, or any components of their formulations.
- Any medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study.
- Participants for whom blood sugar control by insulin preparations is desired (for example, participants with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, or serious trauma before or after surgery).
- Participants with unstable proliferative diabetic retinopathy.
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2025
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT06913101
Start Date
November 15 2024
End Date
May 15 2025
Last Update
April 6 2025
Active Locations (1)
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1
PNS Hafeez - Naval Hospital
Islamabad, Federal Territory, Pakistan, 44000