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

Khyber Medical College, Peshawar

Status and phase: Invitation-only; Phase 3

Conditions: Glycemic Control for Diabetes Mellitus; Diabetes Mellitus Type 2

Treatments: Drug: Trelagliptin 100 mg; Drug: Sitagliptin 100mg OD

Study type: Interventional

Funder types: Other

Identifiers

NCT07073768

KhyberMC

Details and patient eligibility

About

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.

Full description

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder associated with significant microvascular and macrovascular complications. In many patients, blood sugar levels remain above target despite treatment with metformin, which is the usual first-line therapy. Additional treatments are often required to achieve optimal glycemic control.

Dipeptidyl peptidase-4 (DPP-4) inhibitors are oral medications used in managing T2DM. They work by preventing the breakdown of incretin hormones, which help regulate insulin secretion and lower blood glucose levels. Most DPP-4 inhibitors, including sitagliptin, require daily dosing. Trelagliptin is a once-weekly DPP-4 inhibitor that has shown higher potency against the DPP-4 enzyme in preclinical and clinical studies. Trelagliptin is approved for use in Japan but has limited availability and data in other countries, including Pakistan.

This randomized controlled trial aims to compare the efficacy and patient experience of Trelagliptin and Sitagliptin in patients with T2DM who have not achieved glycemic targets with metformin alone. The study seeks to evaluate whether once-weekly Trelagliptin provides similar or superior glycemic control compared to once-daily Sitagliptin and whether it improves treatment adherence and patient satisfaction due to reduced dosing frequency.

Participants will be randomly assigned in a 1:1 ratio to either the Trelagliptin group or the Sitagliptin group. The Trelagliptin group will receive a once-weekly dose of 100 mg oral Trelagliptin for 3 months. The Sitagliptin group will receive 100 mg of oral Sitagliptin once daily for 3 months. Both groups will continue metformin therapy as previously prescribed.

Glycemic control will be assessed through measurements of HbA1c at baseline and after 3 months of treatment. Additional evaluations include fasting blood sugar (FBS) and two-hour post-breakfast random blood sugar (RBS) levels measured monthly. Participants will be asked to maintain a medication diary to record doses taken. Treatment adherence will be assessed through the diary entries and through participant interviews. Treatment satisfaction will be evaluated using the Diabetes Treatment Satisfaction Questionnaire (DTSQ).

The study will be conducted at the Department of Medicine, Khyber Teaching Hospital, Pakistan. Data will be collected and analyzed using standard statistical methods. The primary outcome is the change in HbA1c from baseline to 3 months. Secondary outcomes include changes in FBS and RBS levels, treatment adherence rates, and patient-reported treatment satisfaction.

This study is expected to generate valuable evidence on the efficacy and patient acceptability of Trelagliptin in a Pakistani population and may help inform clinical decision-making regarding once-weekly versus daily DPP-4 inhibitor therapy for T2DM.

Enrollment: 126 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Trelagliptin Arm

Experimental group

Description:

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.

Treatment:

Drug: Trelagliptin 100 mg

Sitagliptin Arm

Active Comparator group

Description:

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.

Treatment:

Drug: Sitagliptin 100mg OD