Comparison of Once-Weekly Trelagliptin Vs. Once-Daily Vildagliptin for HbA1c Reduction in Type 2 Diabetes
Launched by LAHORE GENERAL HOSPITAL · Mar 16, 2025
Trial Information
Current as of April 29, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different medications for people with type 2 diabetes: trelagliptin, which is taken once a week, and vildagliptin, which is taken once a day. Researchers want to see which medication is better at lowering blood sugar levels, specifically looking to see how many participants can achieve an HbA1c level (a measure of blood sugar control over time) of less than 7% after three months. The trial includes adults aged 30 to 60 years who have been diagnosed with type 2 diabetes and have certain blood sugar levels.
To participate in the study, individuals must be in good health overall, meaning they shouldn't have serious heart problems, kidney issues, or other specific medical conditions. They also should not be pregnant or breastfeeding. If eligible, participants will be randomly assigned to receive one of the two medications and will be monitored for changes in their blood sugar levels throughout the trial. This study aims to find out if a weekly medication can help people stick to their treatment plan better than a daily one, which could ultimately improve diabetes management.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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.
About Lahore General Hospital
Lahore General Hospital is a leading healthcare institution in Pakistan, dedicated to advancing medical research and improving patient care through innovative clinical trials. With a commitment to ethical standards and patient safety, the hospital collaborates with a diverse team of experienced healthcare professionals and researchers to conduct high-quality studies across various medical disciplines. By leveraging state-of-the-art facilities and a robust patient population, Lahore General Hospital aims to contribute valuable insights to the medical community and enhance treatment options for patients both locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lahore, Punjab, Pakistan
Patients applied
Trial Officials
Muhammad Irfan Jamil
Principal Investigator
Lahore General Hospital, Lahore
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported