An interventional study of Trelagliptin 100 mg and Vildagliptin 50 mg in Type 2 Diabetes Mellitus (T2DM), sponsored by PNS Hafeez - Naval Hospital. Active, not recruiting at 1 site in Pakistan. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by PNS Hafeez - Naval Hospital · Not applicable, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 102 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →PNS Hafeez - Naval Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants received trelagliptin 100 mg administered orally once weekly before breakfast on the same day of the week.
Drug: Trelagliptin 100 mg
Participants received vildagliptin 50 mg administered orally once daily.
Drug: Vildagliptin 50 mg
Trelagliptin 100 mg was administered orally once weekly before breakfast on the same day of the week.
Vildagliptin 50 mg was administered orally once daily.
Percentage of Participants Achieving HbA1c <7%
The primary outcome measure was the proportion of participants in each treatment group (trelagliptin vs. vildagliptin) who achieved an HbA1c level of less than 7% after three months of treatment. This outcome assessed the efficacy of once-weekly trelagliptin compared to once-daily vildagliptin in glycemic control among patients with type 2 diabetes mellitus.
Time frame: At 3 months after treatment initiation
Mean Reduction in HbA1c Levels
The secondary outcome measure was the mean reduction in HbA1c levels from baseline to three months post-treatment in both groups. This outcome evaluated the extent of glycemic improvement achieved with trelagliptin versus vildagliptin.
Time frame: At 3 months after treatment initiation
Plan to share: No
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This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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PNS Hafeez - Naval Hospital