Clinical trial NCT06913101: Comparison of Once-Weekly Trelagliptin vs. Once-Daily Vildagliptin for HbA1c Reduction in Type 2 Diabetes
Official title: Comparison of Efficacy of Once Weekly Dose of Trelagliptin Versus Once Daily Dose of Vildagliptin on the Levels of HbA1c in Type-2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Type 2 Diabetes Mellitus
HbA1c Reduction
Antidiabetic Therapy
Lead sponsor: PNS Hafeez - Naval Hospital
Sponsor class: OTHER_GOV
First posted: 2025-04-06
Enrollment: 102
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 total of 102 participants, aged 30-60 years with HbA1c levels between 7.5% and 9.5%, were enrolled and randomly assigned to either the trelagliptin or vildagliptin group. The primary outcome measured was the percentage of participants achieving an HbA1c level of less than 7% after three months of treatment. Secondary outcomes included the mean reduction in HbA1c levels from baseline. The study aimed to determine whether trelagliptin, with its once-weekly dosing regimen, could improve medication adherence and glycemic control compared to the conventional daily administration of vildagliptin. Data were analyzed using SPSS version 26.0, with independent t-tests and chi-square tests employed for statistical comparisons. Findings from this study contributed to the understanding of the clinical effectiveness of weekly versus daily DPP-4 inhibitors in the management of T2DM.

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 institutions, ensuring the confidentiality and privacy of all participant data. Potential study participants were provided with detailed information about the study protocols, including the objectives, procedures, potential risks, and benefits of participation. Informed consent was obtained from all participants who met the inclusion criteria and agreed to participate after fully understanding the study details. Participants were diagnosed with type 2 diabetes according to standard diagnostic criteria as per the operational definition. A detailed history was taken to gather basic demographic and clinical data such as age, gender, and comorbidities. Baseline laboratory investigations, including liver function tests (LFTs), renal function tests (RFTs), serum electrolytes, and fundoscopy, were conducted to ensure participants met the selection criteria.

Eligible participants were randomly assigned to one of two treatment groups (Group A or Group B) using a lottery method to ensure equal and unbiased distribution.

Group A received trelagliptin 100 mg once weekly before breakfast on the same day of the week. Group B received vildagliptin 50 mg once daily. Both groups followed the prescribed treatment regimen for a duration of three months. Participants were followed up at three months of treatment. Outcome assessments included monitoring the mean reduction in HbA1c levels and evaluating the efficacy of the treatment, aiming for an HbA1c level of less than 7% after three months of treatment. Data were collected using a data collection proforma.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants Achieving HbA1c <7%
timeFrame: At 3 months after treatment initiation
Secondary outcomes:
measure: Mean Reduction in HbA1c Levels
timeFrame: At 3 months after treatment initiation
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: PNS Hafeez - Naval Hospital
state: Federal territory
Study officials:
affiliation: PNS Hafeez - Naval Hospital
name: Hamza Ali
role: PRINCIPAL_INVESTIGATOR
References: