Diabetes Mellitus Type 2Phase 3NCT07073768
Comparison Between Efficacy of Trelagliptin and Sitagliptin in Type II Diabetic Patients
A Phase 3 study testing Trelagliptin 100 mg and Sitagliptin 100mg OD in people with Diabetes Mellitus Type 2 and Glycemic Control for Diabetes Mellitus, run by Khyber Medical College, Peshawar at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus Type 2, Glycemic Control for Diabetes Mellitus
- What is being tested?
- Trelagliptin 100 mg and Sitagliptin 100mg OD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2025to 30 Dec 2026
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Khyber Teaching Hospital / Khyber Medical College
Peshawar, Khyber Pakhtunkhwa, 25120
About this study
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:
Read more
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.
Read the detailed 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.
- Being tested
- Trelagliptin 100 mg, Sitagliptin 100mg OD
- Keywords
- Type 2 Diabetes Mellitus, T2DM, Diabetes, Trelagliptin, SYR-472, Sitagliptin, DPP-4 Inhibitors, Dipeptidyl Peptidase-4 Inhibitors, RCT
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trelagliptin 100 mgDrug
Also called SYR-472
Trelagliptin will be administered as oral tablets at a dose of 100 mg once weekly for 3 months. Participants will continue background metformin therapy as prescribed. Trelagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated for type 2 diabetes mellitus and differs from daily DPP-4 inhibitors due to its longer duration of action, allowing weekly dosing.
Sitagliptin 100mg ODDrug
Sitagliptin will be administered as oral tablets at a dose of 100 mg once daily for 3 months. Participants will continue background metformin therapy as prescribed. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated for type 2 diabetes mellitus and requires daily dosing.
| Study group | Role | What they receive |
|---|---|---|
| Trelagliptin Arm | 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. Receives: Drug: Trelagliptin 100 mg |
| Sitagliptin Arm | 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. Receives: Drug: Sitagliptin 100mg OD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c (HbA1c)
The mean change in HbA1c levels from baseline to 3 months of treatment, comparing Trelagliptin and Sitagliptin groups. HbA1c is measured as a percentage and reflects average blood glucose over the prior 2-3 months.
Measured: 3 Months
Secondary outcomes (2)
Change in Fasting Blood Sugar (FBS)
The mean change in fasting blood glucose levels from baseline to monthly time points during 3 months of treatment, comparing Trelagliptin and Sitagliptin groups.
Measured: Baseline, monthly for 3 months
Change in 2-Hour Post-Breakfast Random Blood Sugar (RBS)
The mean change in blood glucose levels measured 2 hours after breakfast, from baseline to monthly time points during 3 months of treatment, comparing Trelagliptin and Sitagliptin groups.
Measured: Baseline, monthly for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Jul 2025
- Primary completion26 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Medical College, Peshawar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Aliena Badshah, Khyber Medical College, Peshawar
- Investigators
- Aliena Badshah, MBBS, FCPS, MRCP, Principal investigator, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073768
- Sponsor's protocol ID
- KhyberMC
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding sharing individual participant data (IPD) has not yet been made. Considerations include participant privacy, institutional policies, and regulatory requirements.
Publications
Inagaki N, Sano H, Seki Y, Kuroda S, Kaku K. Efficacy and safety of once-weekly oral trelagliptin switched from once-daily dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes mellitus: An open-label, phase 3 exploratory study. J Diabetes Investig. 2018 Mar;9(2):354-359. doi: 10.1111/jdi.12730. Epub 2017 Oct 30.
PubMed 28836351Dutta D, Mohindra R, Surana V, Sharma M. Safety and efficacy of once weekly dipeptidyl-peptidase-4 inhibitor trelagliptin in type-2 diabetes: A meta-analysis. Diabetes Metab Syndr. 2022 Apr;16(4):102469. doi: 10.1016/j.dsx.2022.102469. Epub 2022 Mar 21.
PubMed 35344848Ahren B. Use of DPP-4 inhibitors in type 2 diabetes: focus on sitagliptin. Diabetes Metab Syndr Obes. 2010 Mar 29;3:31-41. doi: 10.2147/dmsott.s7327.
PubMed 21437074Deacon CF, Lebovitz HE. Comparative review of dipeptidyl peptidase-4 inhibitors and sulphonylureas. Diabetes Obes Metab. 2016 Apr;18(4):333-47. doi: 10.1111/dom.12610. Epub 2016 Jan 8.
PubMed 26597596Kim HJ, Kim YS, Lee CB, Choi MG, Chang HJ, Kim SK, Yu JM, Kim TH, Lee JH, Ahn KJ, Min KW, Kyung EJ, Kim YK, Lee KW. Efficacy and Safety of Switching to Teneligliptin in Patients with Type 2 Diabetes Inadequately Controlled with Dipeptidyl Peptidase-4 Inhibitors: 52-Week Results from a Prospective Observational Study. Diabetes Ther. 2021 Nov;12(11):2907-2920. doi: 10.1007/s13300-021-01148-1. Epub 2021 Sep 18.
PubMed 34536208Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.
PubMed 10938048Grimshaw CE, Jennings A, Kamran R, Ueno H, Nishigaki N, Kosaka T, Tani A, Sano H, Kinugawa Y, Koumura E, Shi L, Takeuchi K. Trelagliptin (SYR-472, Zafatek), Novel Once-Weekly Treatment for Type 2 Diabetes, Inhibits Dipeptidyl Peptidase-4 (DPP-4) via a Non-Covalent Mechanism. PLoS One. 2016 Jun 21;11(6):e0157509. doi: 10.1371/journal.pone.0157509. eCollection 2016.
PubMed 27328054Nishimura R, Osonoi T, Koike Y, Miyata K, Shimasaki Y. A Randomized Pilot Study of the Effect of Trelagliptin and Alogliptin on Glycemic Variability in Patients with Type 2 Diabetes. Adv Ther. 2019 Nov;36(11):3096-3109. doi: 10.1007/s12325-019-01097-z. Epub 2019 Sep 27.
PubMed 31562608
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Efficacy of Trelagliptin and Sitagliptin in Type II Diabetic Patients
- ClinicalTrials.gov ID
- NCT07073768
- Acronym / sponsor ID
- KhyberMC
- Keywords
- Type 2 Diabetes Mellitus, T2DM, Diabetes, Trelagliptin, SYR-472, Sitagliptin, DPP-4 Inhibitors, Dipeptidyl Peptidase-4 Inhibitors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Khyber Medical College, PeshawarUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 26 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Jul 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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trelagliptin Arm | Experimental | Drug: Trelagliptin 100 mgA 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. |
| Sitagliptin Arm | Active comparator | Drug: Sitagliptin 100mg ODA 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- • Type 2 Diabetic patients visiting Medical OPD
Key exclusion criteria (11 listed)
- • Type 1 Diabetic Patients
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 mgAlso: SYR-472Trelagliptin will be administered as oral tablets at a dose of 100 mg once weekly for 3 months. Participants will continue background metformin therapy as prescribed. Trelagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated for type 2 diabetes mellitus and differs from daily DPP-4 inhibitors due to its longer duration of action, allowing weekly dosing. | Drug | Trelagliptin Arm |
| Sitagliptin 100mg ODSitagliptin will be administered as oral tablets at a dose of 100 mg once daily for 3 months. Participants will continue background metformin therapy as prescribed. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated for type 2 diabetes mellitus and requires daily dosing. | Drug | Sitagliptin Arm |
Primary outcome
Change in Hemoglobin A1c (HbA1c)
Time frame: 3 Months
The mean change in HbA1c levels from baseline to 3 months of treatment, comparing Trelagliptin and Sitagliptin groups. HbA1c is measured as a percentage and reflects average blood glucose over the prior 2-3 months.
2 secondary outcomes
Change in Fasting Blood Sugar (FBS)
Time frame: Baseline, monthly for 3 months
Change in 2-Hour Post-Breakfast Random Blood Sugar (RBS)
Time frame: Baseline, monthly for 3 months
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 18 Jul 2025.
- Background: PubMed 28836351Inagaki N, Sano H, Seki Y, Kuroda S, Kaku K. Efficacy and safety of once-weekly oral trelagliptin switched from once-daily dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes mellitus: An open-label, phase 3 exploratory study. J Diabetes Investig. 2018 Mar;9(2):354-359. doi: 10.1111/jdi.12730. Epub 2017 Oct 30.
- Background: PubMed 35344848Dutta D, Mohindra R, Surana V, Sharma M. Safety and efficacy of once weekly dipeptidyl-peptidase-4 inhibitor trelagliptin in type-2 diabetes: A meta-analysis. Diabetes Metab Syndr. 2022 Apr;16(4):102469. doi: 10.1016/j.dsx.2022.102469. Epub 2022 Mar 21.
- Background: PubMed 21437074Ahren B. Use of DPP-4 inhibitors in type 2 diabetes: focus on sitagliptin. Diabetes Metab Syndr Obes. 2010 Mar 29;3:31-41. doi: 10.2147/dmsott.s7327.
- Background: PubMed 26597596Deacon CF, Lebovitz HE. Comparative review of dipeptidyl peptidase-4 inhibitors and sulphonylureas. Diabetes Obes Metab. 2016 Apr;18(4):333-47. doi: 10.1111/dom.12610. Epub 2016 Jan 8.
- Background: PubMed 34536208Kim HJ, Kim YS, Lee CB, Choi MG, Chang HJ, Kim SK, Yu JM, Kim TH, Lee JH, Ahn KJ, Min KW, Kyung EJ, Kim YK, Lee KW. Efficacy and Safety of Switching to Teneligliptin in Patients with Type 2 Diabetes Inadequately Controlled with Dipeptidyl Peptidase-4 Inhibitors: 52-Week Results from a Prospective Observational Study. Diabetes Ther. 2021 Nov;12(11):2907-2920. doi: 10.1007/s13300-021-01148-1. Epub 2021 Sep 18.
- Background: PubMed 10938048Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.
- Background: PubMed 27328054Grimshaw CE, Jennings A, Kamran R, Ueno H, Nishigaki N, Kosaka T, Tani A, Sano H, Kinugawa Y, Koumura E, Shi L, Takeuchi K. Trelagliptin (SYR-472, Zafatek), Novel Once-Weekly Treatment for Type 2 Diabetes, Inhibits Dipeptidyl Peptidase-4 (DPP-4) via a Non-Covalent Mechanism. PLoS One. 2016 Jun 21;11(6):e0157509. doi: 10.1371/journal.pone.0157509. eCollection 2016.
- Background: PubMed 31562608Nishimura R, Osonoi T, Koike Y, Miyata K, Shimasaki Y. A Randomized Pilot Study of the Effect of Trelagliptin and Alogliptin on Glycemic Variability in Patients with Type 2 Diabetes. Adv Ther. 2019 Nov;36(11):3096-3109. doi: 10.1007/s12325-019-01097-z. Epub 2019 Sep 27.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. A decision regarding sharing individual participant data (IPD) has not yet been made. Considerations include participant privacy, institutional policies, and regulatory requirements.
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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.
Aliena Badshah, MBBS, FCPS, MRCP principal investigator
Khyber Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trelagliptin 100 mg and Sitagliptin 100mg OD in people with Diabetes Mellitus Type 2 and Glycemic Control for Diabetes Mellitus, run by Khyber Medical College, Peshawar 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 11 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: enrolling by invitation, as of the sponsor's last update on 18 Jul 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Hemoglobin A1c (HbA1c) (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07073768, which also lists 8 linked publications.
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 18 Jul 2025.