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

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.

Timeline

Start

2025-07-01

Primary completion

2026-12-26

Completion

2026-12-30

Publications

• Background 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.
• 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.
• Background Ahren 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 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.
• 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.
• 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.
• 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.
• Background Nishimura 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.

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