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Comparison Between Efficacy of Trelagliptin and Sitagliptin in Type II Diabetic Patients

NCT07073768 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-07-18

No results posted yet for this study

Summary

The goal of this clinical trial is to find out if a medicine called Trelagliptin works as well as another medicine called Sitagliptin to lower blood sugar levels in people with type 2 diabetes who have not reached their target sugar levels with metformin alone.

The main questions this study aims to answer are:

Does Trelagliptin lower average blood sugar levels (measured by HbA1c) as well as Sitagliptin over 3 months? Does Trelagliptin help reduce swings in blood sugar levels compared to Sitagliptin? Are people more likely to stick to taking Trelagliptin, which is taken once a week, than Sitagliptin, which is taken every day? How satisfied are people with their treatment when using Trelagliptin versus Sitagliptin?

Researchers will compare two groups:

One group will take Trelagliptin once a week for 3 months. The other group will take Sitagliptin once a day for 3 months.

Participants in the study will:

Answer questions about their health and how they feel about their diabetes treatment.

Have blood tests to measure blood sugar levels, including:

HbA1c (an average measure of blood sugar over 2-3 months) Fasting blood sugar levels Blood sugar levels two hours after breakfast Keep records of how often they take their medicine.

People can take part in this study if:

They have type 2 diabetes and are taking metformin but still have higher-than-desired blood sugar levels.

They are between certain blood sugar ranges (HbA1c higher than 6.5% but lower than 10%).

They are willing to give informed consent and follow study instructions.

People cannot take part if:

They have type 1 diabetes. They have certain serious health conditions, such as severe kidney disease, heart problems, cancer, or are pregnant.

They are already taking Trelagliptin or are in another clinical study. The study will take place at Khyber Teaching Hospital in Pakistan and will last about 3 months for each participant.

Conditions

  • Diabetes Mellitus Type 2
  • Glycemic Control for Diabetes Mellitus

Interventions

DRUG

Trelagliptin 100 mg

Trelagliptin will be administered as oral tablets at a dose of 100 mg once weekly for 3 months. Participants will continue background metformin therapy as prescribed. Trelagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated for type 2 diabetes mellitus and differs from daily DPP-4 inhibitors due to its longer duration of action, allowing weekly dosing.

DRUG

Sitagliptin 100mg OD

Sitagliptin will be administered as oral tablets at a dose of 100 mg once daily for 3 months. Participants will continue background metformin therapy as prescribed. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated for type 2 diabetes mellitus and requires daily dosing.

Sponsors & Collaborators

  • Khyber Medical College, Peshawar

    lead OTHER

Principal Investigators

  • Aliena Badshah, MBBS, FCPS, MRCP · Khyber Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-12-26
Completion
2026-12-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07073768 on ClinicalTrials.gov