Trelagliptin and Sitagliptin for Type II Diabetes
Trelagliptin 100 mg
+ Sitagliptin 100mg OD
Diabetes Mellitus+3
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.126 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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
Khyber Teaching Hospital / Khyber Medical College
Peshawar, PakistanOpen Khyber Teaching Hospital / Khyber Medical College in Google Maps