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Trelagliptin and Sitagliptin for Type II Diabetes

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What is being tested

Trelagliptin 100 mg

+ Sitagliptin 100mg OD

Drug
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorKhyber Medical College, Peshawar
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2025

Actual date on which the first participant was enrolled.

Type 2 diabetes is a long-lasting condition where the body struggles to keep blood sugar levels in check, leading to various health problems if not managed well. Many people with this condition take a common medication called metformin, but it doesn't always work perfectly on its own. This study is exploring whether a different approach using two drugs, Trelagliptin and Sitagliptin, might help. Both of these drugs belong to a class of medicines that help control blood sugar by affecting a hormone related to insulin. Trelagliptin is taken once a week, while Sitagliptin is taken daily. The study focuses on patients who haven't reached their blood sugar goals with just metformin, aiming to see if Trelagliptin's less frequent dosing might be just as effective or even better than Sitagliptin, while also being more convenient. Participants in the study are divided into two groups: one group takes Trelagliptin once a week, and the other takes Sitagliptin every day, both for three months, while continuing their metformin treatment. Their blood sugar levels are monitored by checking a specific measure called HbA1c before and after the treatment period, along with other blood sugar tests each month. Participants keep a diary to track their medication use and share their experiences through interviews and a satisfaction questionnaire. This helps researchers understand how well patients stick to their treatment and how satisfied they are with their therapy. The study takes place at a hospital in Pakistan and aims to provide insights that could improve diabetes treatment approaches.

Official TitleComparison Between Efficacy of Trelagliptin and Sitagliptin in Type II Diabetic Patients
NCT07073768
Principal SponsorKhyber Medical College, Peshawar
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

126 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

Inclusion Criteria: * • Type 2 Diabetic patients visiting Medical OPD * Patients already maintaining lifestyle modifications and on metformin monotherapy, but not achieving target HbA1c levels. * Patients who require treatment with a DPP-4 inhibitors * Patients with baseline HbA1c \> 6.5% and \< 10% * Patients willing to provide written informed consent prior to recruitment Exclusion Criteria: * • Type 1 Diabetic Patients * Patients already using Trelagliptin for type 2 diabetes * Patients with severe renal impairment (eGFR \< 30ml/min/1.73m2 or on dialysis) * Patients with Serious Heart disease or Cerebrovascular disease * Patients with Serious Pancreatic or blood disease * Patients with malignancy * Patients with history of hypersensitivity to DPP-4 inhibitors * Patients with history of gastrointestinal resection * Pregnant, Breast feeding or planning to be pregnant patients * Patients participating in other clinical studies * Patients assessed as ineligible by researchers due to any other reason

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
A total of 63 participants will receive Trelagliptin 100 mg taken orally once weekly for 3 months. All participants will continue their background metformin therapy as previously prescribed. The study will assess changes in HbA1c, fasting blood sugar, postprandial blood sugar, treatment adherence, and patient satisfaction compared to Sitagliptin.

Group II

Active Comparator
A total of 63 participants will receive Sitagliptin 100 mg taken orally once daily for 3 months. All participants will continue their background metformin therapy as previously prescribed. The study will assess changes in HbA1c, fasting blood sugar, postprandial blood sugar, treatment adherence, and patient satisfaction compared to Trelagliptin.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Khyber Teaching Hospital / Khyber Medical College

Peshawar, PakistanOpen Khyber Teaching Hospital / Khyber Medical College in Google Maps
Enrolling by invitationOne Study Center
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