Comparison of Once-Weekly Trelagliptin Vs. Once-Daily Vildagliptin for HbA1c Reduction in Type 2 Diabetes

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Drug: Trelagliptin 100 mg; Drug: Vildagliptin 50 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Lahore General Hospital, Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Trelagliptin; Participants received trelagliptin 100 mg administered orally once weekly before breakfast on the same day of the week.	Drug: Trelagliptin 100 mg; Trelagliptin 100 mg was administered orally once weekly before breakfast on the same day of the week.
Active Comparator: Group Vildagliptin; Participants received vildagliptin 50 mg administered orally once daily.	Drug: Vildagliptin 50 mg; Vildagliptin 50 mg was administered orally once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 3 months after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 3 months after treatment initiation

Collaborators and Investigators

• Sponsor: Lahore General Hospital
• Investigators: Principal Investigator: Muhammad Irfan Jamil, Lahore General Hospital, Lahore

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: March 16, 2025
• First Submitted That Met QC Criteria: March 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus; Vildagliptin; HbA1c Reduction; Trelagliptin; Antidiabetic Therapy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Protease Inhibitors; Enzyme Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Vildagliptin
• Other Study ID Numbers: LahoreGeneralH4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No