Protocol for a randomized controlled study comparing the efficacy and safety of daily versus alternate day teneligliptin 20 mg in type 2 diabetes mellitus patients
DOI:
https://doi.org/10.18203/2349-3259.ijct20251211Keywords:
DPP-4-inhibitor, Metformin, Type 2 diabetes mellitus, TeneligliptinAbstract
Background: For effective management of type 2 diabetes mellitus (T2DM), in addition to efficacy, safety, compliance and cost play a considerable role. Teneligliptin has long elimination half-life (24 hours) and offers a potential to be administered on alternate days. But there is paucity of robust clinical evidence. This study seeks to compare efficacy and safety of daily and alternate day teneligliptin therapy.
Methods: This is a single-center, open label, parallel group, randomized controlled study. A total of 60 adults suffering from T2DM with HbA1c 7 to 9 %, who received at least 3 months of metformin (≥1000 mg), will be enrolled. The participants will be randomized in 1:1 ratio into two groups (30 participants per group) receiving daily or alternated day teneligliptin 20 mg over and above standard of care for a duration of 3 months. The primary end point is change in HbA1c levels from baseline after 3 months of initiating teneligliptin 20 mg therapy. Data analysis will be done using SYSTAT software (13.2 version for windows, San Jose, CA: Inpixon Inc.) and the Intention-to-Treat approach will be employed for the analysis.
Conclusions: If alternate day teneligliptin add on therapy proves to have comparable efficacy with daily therapy, it will provide us with a safe, efficacious and cost-effective alternative in T2DM patients. This study has potential to bring down the public health and economic burdens associated with management of T2DM.
Trial registration: CTRI number: CTRI/2024/06/068564.
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References
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