Pleiotropic effect of teneligliptin versus glimepiride add-on therapy on hs-CRP and cardiorenal parameters in Indian type 2 diabetes patients: An open-labeled randomized controlled trial
Objective: The objective of the study was to estimate the pleiotropic effect of teneligliptin on high-sensitivity C-reactive protein (hs-CRP) levels and some cardiorenal parameters in comparison to glimepiride, both as add-on therapy to metformin. Methodology: This 12-week open-label, parallel-group...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2025-01-01
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| Series: | Perspectives in Clinical Research |
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| Online Access: | https://journals.lww.com/10.4103/picr.picr_265_23 |
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| author | M Kanimozhi Manisha Bisht Ravikant Arkapal Bandyopadhyay Manisha Naithani Shailendra Handu |
| author_facet | M Kanimozhi Manisha Bisht Ravikant Arkapal Bandyopadhyay Manisha Naithani Shailendra Handu |
| author_sort | M Kanimozhi |
| collection | DOAJ |
| description | Objective:
The objective of the study was to estimate the pleiotropic effect of teneligliptin on high-sensitivity C-reactive protein (hs-CRP) levels and some cardiorenal parameters in comparison to glimepiride, both as add-on therapy to metformin.
Methodology:
This 12-week open-label, parallel-group, randomized controlled trial was conducted among Indian people with type 2 diabetes mellitus and on metformin monotherapy with poor glycemic control (glycated hemoglobin >7% or 53 mmol/mol). The endpoints were mean change in hs-CRP levels, systolic blood pressure (SBP), diastolic blood pressure (DBP), serum creatinine, blood urea, estimated glomerular filtration rate (eGFR), and change in cardiovascular (CV) risk categories from baseline to end of 12 weeks.
Results:
Seventy participants were randomized (1:1) to receive either teneligliptin 20 mg once daily (n = 35) or glimepiride 1 mg twice daily (BD) (n = 35) as an add-on to metformin 500 mg BD. The mean age of the participants was 50.65 and 50.7 years in arms 1 and 2, respectively. At 12-weeks end, teneligliptin add-on caused a statistically significant reduction in hs-CRP compared to glimepiride in both per-protocol (PP) and intention-to-treat (ITT) sets. No significant difference was observed for changes in SBP and DBP, creatinine, urea, eGFR levels, and CV risk category in both PP and ITT sets.
Conclusion:
Teneligliptin add-on resulted in favorable effects on hs-CRP levels and comparable effects on cardiorenal parameters compared to glimepiride add-on therapy at 12-weeks end.
This trial has been prospectively registered in CTRI (Clinical Trials Registry of India). Registration number: CTRI/2021/08/035342. |
| format | Article |
| id | doaj-art-d086310caeb7428dbe69f5862239e85f |
| institution | Kabale University |
| issn | 2229-3485 2229-5488 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Perspectives in Clinical Research |
| spelling | doaj-art-d086310caeb7428dbe69f5862239e85f2025-01-14T08:49:31ZengWolters Kluwer Medknow PublicationsPerspectives in Clinical Research2229-34852229-54882025-01-01161142210.4103/picr.picr_265_23Pleiotropic effect of teneligliptin versus glimepiride add-on therapy on hs-CRP and cardiorenal parameters in Indian type 2 diabetes patients: An open-labeled randomized controlled trialM KanimozhiManisha BishtRavikantArkapal BandyopadhyayManisha NaithaniShailendra HanduObjective: The objective of the study was to estimate the pleiotropic effect of teneligliptin on high-sensitivity C-reactive protein (hs-CRP) levels and some cardiorenal parameters in comparison to glimepiride, both as add-on therapy to metformin. Methodology: This 12-week open-label, parallel-group, randomized controlled trial was conducted among Indian people with type 2 diabetes mellitus and on metformin monotherapy with poor glycemic control (glycated hemoglobin >7% or 53 mmol/mol). The endpoints were mean change in hs-CRP levels, systolic blood pressure (SBP), diastolic blood pressure (DBP), serum creatinine, blood urea, estimated glomerular filtration rate (eGFR), and change in cardiovascular (CV) risk categories from baseline to end of 12 weeks. Results: Seventy participants were randomized (1:1) to receive either teneligliptin 20 mg once daily (n = 35) or glimepiride 1 mg twice daily (BD) (n = 35) as an add-on to metformin 500 mg BD. The mean age of the participants was 50.65 and 50.7 years in arms 1 and 2, respectively. At 12-weeks end, teneligliptin add-on caused a statistically significant reduction in hs-CRP compared to glimepiride in both per-protocol (PP) and intention-to-treat (ITT) sets. No significant difference was observed for changes in SBP and DBP, creatinine, urea, eGFR levels, and CV risk category in both PP and ITT sets. Conclusion: Teneligliptin add-on resulted in favorable effects on hs-CRP levels and comparable effects on cardiorenal parameters compared to glimepiride add-on therapy at 12-weeks end. This trial has been prospectively registered in CTRI (Clinical Trials Registry of India). Registration number: CTRI/2021/08/035342.https://journals.lww.com/10.4103/picr.picr_265_23dipeptidyl peptidase-4 inhibitorsglimepiridehigh-sensitivity c-reactive proteinpleiotropic effectsteneligliptintype 2 diabetes |
| spellingShingle | M Kanimozhi Manisha Bisht Ravikant Arkapal Bandyopadhyay Manisha Naithani Shailendra Handu Pleiotropic effect of teneligliptin versus glimepiride add-on therapy on hs-CRP and cardiorenal parameters in Indian type 2 diabetes patients: An open-labeled randomized controlled trial Perspectives in Clinical Research dipeptidyl peptidase-4 inhibitors glimepiride high-sensitivity c-reactive protein pleiotropic effects teneligliptin type 2 diabetes |
| title | Pleiotropic effect of teneligliptin versus glimepiride add-on therapy on hs-CRP and cardiorenal parameters in Indian type 2 diabetes patients: An open-labeled randomized controlled trial |
| title_full | Pleiotropic effect of teneligliptin versus glimepiride add-on therapy on hs-CRP and cardiorenal parameters in Indian type 2 diabetes patients: An open-labeled randomized controlled trial |
| title_fullStr | Pleiotropic effect of teneligliptin versus glimepiride add-on therapy on hs-CRP and cardiorenal parameters in Indian type 2 diabetes patients: An open-labeled randomized controlled trial |
| title_full_unstemmed | Pleiotropic effect of teneligliptin versus glimepiride add-on therapy on hs-CRP and cardiorenal parameters in Indian type 2 diabetes patients: An open-labeled randomized controlled trial |
| title_short | Pleiotropic effect of teneligliptin versus glimepiride add-on therapy on hs-CRP and cardiorenal parameters in Indian type 2 diabetes patients: An open-labeled randomized controlled trial |
| title_sort | pleiotropic effect of teneligliptin versus glimepiride add on therapy on hs crp and cardiorenal parameters in indian type 2 diabetes patients an open labeled randomized controlled trial |
| topic | dipeptidyl peptidase-4 inhibitors glimepiride high-sensitivity c-reactive protein pleiotropic effects teneligliptin type 2 diabetes |
| url | https://journals.lww.com/10.4103/picr.picr_265_23 |
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