Type 2 Diabetes Mellitus (T2DM)NCT06913101
Comparison of Once-Weekly Trelagliptin vs. Once-Daily Vildagliptin for HbA1c Reduction in Type 2 Diabetes
A study testing Trelagliptin 100 mg and Vildagliptin 50 mg in people with Type 2 Diabetes Mellitus (T2DM), run by PNS Hafeez - Naval Hospital at 1 site in Pakistan.
Trial summary
This randomized controlled trial evaluated the efficacy of once-weekly trelagliptin compared to once-daily vildagliptin in reducing HbA1c levels in patients with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Trelagliptin 100 mg and Vildagliptin 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
PNS Hafeez - Naval Hospital
Islamabad, Federal Territory, 44000
About this study
Official title: Comparison of Efficacy of Once Weekly Dose of Trelagliptin Versus Once Daily Dose of Vildagliptin on the Levels of HbA1c in Type-2 Diabetes Patients
This randomized controlled trial evaluated the efficacy of once-weekly trelagliptin compared to once-daily vildagliptin in reducing HbA1c levels in patients with type 2 diabetes mellitus (T2DM). A total of 102 participants, aged 30-60 years with HbA1c levels between 7.5% and 9.5%, were enrolled and randomly assigned to either the trelagliptin or vildagliptin group. The primary outcome measured was the percentage of participants achieving an HbA1c level of less than 7% after three months of treatment. Secondary outcomes included the mean reduction in HbA1c levels from baseline. The study aimed to determine whether trelagliptin, with its once-weekly dosing regimen, could improve medication adherence and glycemic control compared to the conventional daily administration of vildagliptin. Data were analyzed using SPSS version 26.0, with independent t-tests and chi-square tests employed for statistical comparisons. Findings from this study contributed to the understanding of the clinical effectiveness of weekly versus daily DPP-4 inhibitors in the management of T2DM.
Read the detailed description
Before the commencement of the study, ethical approval was obtained from the Institutional Review Board of the hospital. All study procedures adhered strictly to the ethical guidelines of both institutions, ensuring the confidentiality and privacy of all participant data. Potential study participants were provided with detailed information about the study protocols, including the objectives, procedures, potential risks, and benefits of participation. Informed consent was obtained from all participants who met the inclusion criteria and agreed to participate after fully understanding the study details. Participants were diagnosed with type 2 diabetes according to standard diagnostic criteria as per the operational definition. A detailed history was taken to gather basic demographic and clinical data such as age, gender, and comorbidities. Baseline laboratory investigations, including liver function tests (LFTs), renal function tests (RFTs), serum electrolytes, and fundoscopy, were conducted to ensure participants met the selection criteria.
Eligible participants were randomly assigned to one of two treatment groups (Group A or Group B) using a lottery method to ensure equal and unbiased distribution.
Group A received trelagliptin 100 mg once weekly before breakfast on the same day of the week. Group B received vildagliptin 50 mg once daily. Both groups followed the prescribed treatment regimen for a duration of three months. Participants were followed up at three months of treatment. Outcome assessments included monitoring the mean reduction in HbA1c levels and evaluating the efficacy of the treatment, aiming for an HbA1c level of less than 7% after three months of treatment. Data were collected using a data collection proforma.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Trelagliptin 100 mg, Vildagliptin 50 mg
- Keywords
- Type 2 Diabetes Mellitus, HbA1c Reduction, Antidiabetic Therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trelagliptin 100 mgDrug
Trelagliptin 100 mg was administered orally once weekly before breakfast on the same day of the week.
Vildagliptin 50 mgDrug
Vildagliptin 50 mg was administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Group Trelagliptin | Experimental | Participants received trelagliptin 100 mg administered orally once weekly before breakfast on the same day of the week. Receives: Drug: Trelagliptin 100 mg |
| Group Vildagliptin | Active comparator | Participants received vildagliptin 50 mg administered orally once daily. Receives: Drug: Vildagliptin 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving HbA1c <7%
The primary outcome measure was the proportion of participants in each treatment group (trelagliptin vs. vildagliptin) who achieved an HbA1c level of less than 7% after three months of treatment. This outcome assessed the efficacy of once-weekly trelagliptin compared to once-daily vildagliptin in glycemic control among patients with type 2 diabetes mellitus.
Measured: At 3 months after treatment initiation
Secondary outcomes (1)
Mean Reduction in HbA1c Levels
The secondary outcome measure was the mean reduction in HbA1c levels from baseline to three months post-treatment in both groups. This outcome evaluated the extent of glycemic improvement achieved with trelagliptin versus vildagliptin.
Measured: At 3 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start15 Nov 2024
- Primary completion15 May 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- PNS Hafeez - Naval Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hamza Ali, PNS Hafeez - Naval Hospital
- Investigators
- Hamza Ali, Principal investigator, PNS Hafeez - Naval Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913101
- Sponsor's protocol ID
- PNSHafeez1
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Once Weekly Dose of Trelagliptin Versus Once Daily Dose of Vildagliptin on the Levels of HbA1c in Type-2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT06913101
- Acronym / sponsor ID
- PNSHafeez1
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Type 2 Diabetes Mellitus, HbA1c Reduction, Antidiabetic Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- PNS Hafeez - Naval HospitalOther government
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial evaluated the efficacy of once-weekly trelagliptin compared to once-daily vildagliptin in reducing HbA1c levels in patients with type 2 diabetes mellitus (T2DM). A total of 102 participants, aged 30-60 years with HbA1c levels between 7.5% and 9.5%, were enrolled and randomly assigned to either the trelagliptin or vildagliptin group. The primary outcome measured was the percentage of participants achieving an HbA1c level of less than 7% after three months of treatment. Secondary outcomes included the mean reduction in HbA1c levels from baseline. The study aimed to determine whether trelagliptin, with its once-weekly dosing regimen, could improve medication adherence and glycemic control compared to the conventional daily administration of vildagliptin. Data were analyzed using SPSS version 26.0, with independent t-tests and chi-square tests employed for statistical comparisons. Findings from this study contributed to the understanding of the clinical effectiveness of weekly versus daily DPP-4 inhibitors in the management of T2DM.
Detailed description
Before the commencement of the study, ethical approval was obtained from the Institutional Review Board of the hospital. All study procedures adhered strictly to the ethical guidelines of both institutions, ensuring the confidentiality and privacy of all participant data. Potential study participants were provided with detailed information about the study protocols, including the objectives, procedures, potential risks, and benefits of participation. Informed consent was obtained from all participants who met the inclusion criteria and agreed to participate after fully understanding the study details. Participants were diagnosed with type 2 diabetes according to standard diagnostic criteria as per the operational definition. A detailed history was taken to gather basic demographic and clinical data such as age, gender, and comorbidities. Baseline laboratory investigations, including liver function tests (LFTs), renal function tests (RFTs), serum electrolytes, and fundoscopy, were conducted to ensure participants met the selection criteria.
Eligible participants were randomly assigned to one of two treatment groups (Group A or Group B) using a lottery method to ensure equal and unbiased distribution.
Group A received trelagliptin 100 mg once weekly before breakfast on the same day of the week. Group B received vildagliptin 50 mg once daily. Both groups followed the prescribed treatment regimen for a duration of three months. Participants were followed up at three months of treatment. Outcome assessments included monitoring the mean reduction in HbA1c levels and evaluating the efficacy of the treatment, aiming for an HbA1c level of less than 7% after three months of treatment. Data were collected using a data collection proforma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Trelagliptin | Experimental | Drug: Trelagliptin 100 mgParticipants received trelagliptin 100 mg administered orally once weekly before breakfast on the same day of the week. |
| Group Vildagliptin | Active comparator | Drug: Vildagliptin 50 mgParticipants received vildagliptin 50 mg administered orally once daily. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trelagliptin 100 mgTrelagliptin 100 mg was administered orally once weekly before breakfast on the same day of the week. | Drug | Group Trelagliptin |
| Vildagliptin 50 mgVildagliptin 50 mg was administered orally once daily. | Drug | Group Vildagliptin |
Primary outcome
Percentage of Participants Achieving HbA1c <7%
Time frame: At 3 months after treatment initiation
The primary outcome measure was the proportion of participants in each treatment group (trelagliptin vs. vildagliptin) who achieved an HbA1c level of less than 7% after three months of treatment. This outcome assessed the efficacy of once-weekly trelagliptin compared to once-daily vildagliptin in glycemic control among patients with type 2 diabetes mellitus.
1 secondary outcome
Mean Reduction in HbA1c Levels
Time frame: At 3 months after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus (T2DM)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamza Ali principal investigator
PNS Hafeez - Naval Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trelagliptin 100 mg and Vildagliptin 50 mg in people with Type 2 Diabetes Mellitus (T2DM), run by PNS Hafeez - Naval Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving HbA1c <7% (time frame: At 3 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.