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

NCT ID: NCT06889909

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2025-06-15

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group Trelagliptin

Participants received trelagliptin 100 mg administered orally once weekly before breakfast on the same day of the week.

Group Type: EXPERIMENTAL

Trelagliptin 100 mg

Intervention Type: DRUG

Trelagliptin 100 mg was administered orally once weekly before breakfast on the same day of the week.

Group Vildagliptin

Participants received vildagliptin 50 mg administered orally once daily.

Group Type: ACTIVE_COMPARATOR

Vildagliptin 50 mg

Intervention Type: DRUG

Vildagliptin 50 mg was administered orally once daily.

Interventions

Trelagliptin 100 mg

Trelagliptin 100 mg was administered orally once weekly before breakfast on the same day of the week.

Intervention Type: DRUG

Vildagliptin 50 mg

Vildagliptin 50 mg was administered orally once daily.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lahore General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Muhammad Irfan Jamil

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad Irfan Jamil

Role: PRINCIPAL_INVESTIGATOR

Lahore General Hospital, Lahore

Locations

Lahore General Hospital, Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

LahoreGeneralH4

Identifier Type: -

Identifier Source: org_study_id