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

NCT07073768 | Enrolling By Invitation Phase 3 DMC

• 1 other identifier: KhyberMC
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes Mellitus Type 2; Glycemic Control for Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; T2DM; Diabetes; Trelagliptin; SYR-472; Sitagliptin; DPP-4 Inhibitors; Dipeptidyl Peptidase-4 Inhibitors; RCT

Outcome Measures

Primary Outcomes (1)

• 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.

  3 Months

Secondary Outcomes (2)

• Change in Fasting Blood Sugar (FBS)

  Baseline, monthly for 3 months

• Change in 2-Hour Post-Breakfast Random Blood Sugar (RBS)

  Baseline, monthly for 3 months

Other Outcomes (2)

• Treatment Adherence

  Throughout 3 months of treatment

• Patient Treatment Satisfaction

  At 3 months

Study Arms (2)

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.

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.

Drug: Sitagliptin 100mg OD

Interventions

Trelagliptin 100 mg DRUG

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.

Also known as: SYR-472

Trelagliptin Arm

Sitagliptin 100mg OD DRUG

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.

Sitagliptin Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khyber Medical College, Peshawar: lead

Study Sites (1)

Khyber Teaching Hospital / Khyber Medical College

Peshawar, Khyber Pakhtunkhwa, 25120, Pakistan

Location

Related Publications (8)

• 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.

  PMID: 28836351 BACKGROUND

• Dutta 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.

  PMID: 35344848 BACKGROUND

• Diachenko SS. [Development of medical microbiology in the Ukraine]. Vrach Delo. 1988 May;(5):116-20. No abstract available. Russian.

  PMID: 3047982 BACKGROUND

• Deacon 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.

  PMID: 26597596 BACKGROUND

• Kim 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.

  PMID: 34536208 BACKGROUND

• Stratton 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.

  PMID: 10938048 BACKGROUND

• Grimshaw 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.

  PMID: 27328054 BACKGROUND

• Glenn JK, Hofmeister RW, Neikirk H, Wright H. Continuity of care in the referral process: an analysis of family physicians' expectations of consultants. J Fam Pract. 1983 Feb;16(2):329-34.

  PMID: 6822803 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

trelagliptin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Aliena Badshah, MBBS, FCPS, MRCP

  Khyber Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 26, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

PA (1)