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

NCT06889909 | Active Not Recruiting DMC

• 1 other identifier: LahoreGeneralH4
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Type 2 Diabetes Mellitus; HbA1c Reduction; Trelagliptin; Vildagliptin; Antidiabetic Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Reduction in HbA1c Levels

  At 3 months after treatment initiation

Study Arms (2)

Group Trelagliptin

EXPERIMENTAL

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

Drug: Trelagliptin 100 mg

Group Vildagliptin

ACTIVE COMPARATOR

Participants received vildagliptin 50 mg administered orally once daily.

Drug: Vildagliptin 50 mg

Interventions

Trelagliptin 100 mg DRUG

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

Group Trelagliptin

Vildagliptin 50 mg DRUG

Vildagliptin 50 mg was administered orally once daily.

Group Vildagliptin

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lahore General Hospital: lead

Study Sites (1)

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

trelagliptin; Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Muhammad Irfan Jamil

  Lahore General Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 21, 2025
• Study Start: December 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)