A ProspectIve, OpeN-Label, Randomized Study Comparing EffIcacy and Safety of Teneligliptin VErsus Sitagliptin in Indian Patients with Inadequately Controlled Type 2 Diabetes Mellitus: INSITES Study
Teneligliptin is widely prescribed dipeptidyl peptidase-4 inhibitor (DPP-4i) in India because of its economical pricing. However, there is no headto-head trial comparing teneligliptin with any other DPP-4i in Indian setting. We evaluated the efficacy and safety of teneligliptin versus sitagliptin as...
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| Veröffentlicht in: | Journal of the Association of Physicians of India 2019-10, Vol.67 (10), p.14-19 |
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| creator | Mohan, V Ramu, M Poongothai, S Kasthuri, S |
| description | Teneligliptin is widely prescribed dipeptidyl peptidase-4 inhibitor (DPP-4i) in India because of its economical pricing. However, there is no headto-head trial comparing teneligliptin with any other DPP-4i in Indian setting. We evaluated the efficacy and safety of teneligliptin versus sitagliptin as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes mellitus (T2DM).
This prospective, open-label, randomized, active-controlled study enrolled 76 patients (1:1) at 2 centres. Patients received teneligliptin 20 mg or sitagliptin 100 mg orally once daily for 12 weeks as add-on to ongoing metformin or sulfonylurea therapy. Primary endpoint was mean change in glycosylated hemoglobin (HbA1c) from baseline at week 12.
Both arms were comparable (p>0.05) at baseline in terms of age, gender, metformin daily dose, sulfonylurea use, HbA1c, fasting and postprandial blood glucose (FBG and PPBG). At the end of 12 weeks, statistically significant reductions were observed in both teneligliptin and sitagliptin arms in HbA1c (-1.19 ± 1.16% p |
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This prospective, open-label, randomized, active-controlled study enrolled 76 patients (1:1) at 2 centres. Patients received teneligliptin 20 mg or sitagliptin 100 mg orally once daily for 12 weeks as add-on to ongoing metformin or sulfonylurea therapy. Primary endpoint was mean change in glycosylated hemoglobin (HbA1c) from baseline at week 12.
Both arms were comparable (p>0.05) at baseline in terms of age, gender, metformin daily dose, sulfonylurea use, HbA1c, fasting and postprandial blood glucose (FBG and PPBG). At the end of 12 weeks, statistically significant reductions were observed in both teneligliptin and sitagliptin arms in HbA1c (-1.19 ± 1.16% p<0.0001 and -0.92 ± 0.95%, p<0.0001), in FBG (-28.3 ± 63.0 mg/dL, p= 0.01 and -22.9 ± 47.4 mg/dL, p=0.006) and PPBG (-41.3 ± 85.4 mg/dL, p=0.006 and -54.7 ± 85.6 mg/dL, p=0.0005). The reductions in all glycemic parameters were similar between the arms. Both gliptins were well-tolerated with no difference in the number of adverse events. There was no change in QT/QTc intervals or other ECG parameters at week 12 in both arms. In post-hoc comparison, percentage of patients achieving target HbA1c <7% (as per American Diabetes Association guidelines) at week 12 favored teneligliptin arm over sitagliptin arm (33.3% vs. 19.4% patients).
Teneligliptin provided similar glycemic control as compared to sitagliptin and reduced HbA1c, FBG and PPBG values significantly within 12 weeks of treatment. Both gliptins were found to be safe and well-tolerated in Indian patients with T2DM.</description><identifier>ISSN: 0004-5772</identifier><identifier>PMID: 31571445</identifier><language>eng</language><publisher>India</publisher><subject>Diabetes Mellitus, Type 2 - drug therapy ; Dipeptidyl-Peptidase IV Inhibitors - therapeutic use ; Double-Blind Method ; Drug Therapy, Combination ; Humans ; Hypoglycemic Agents - therapeutic use ; India ; Prospective Studies ; Pyrazoles - therapeutic use ; Sitagliptin Phosphate - therapeutic use ; Thiazolidines - therapeutic use</subject><ispartof>Journal of the Association of Physicians of India, 2019-10, Vol.67 (10), p.14-19</ispartof><rights>Journal of the Association of Physicians of India 2011.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,778,782</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31571445$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mohan, V</creatorcontrib><creatorcontrib>Ramu, M</creatorcontrib><creatorcontrib>Poongothai, S</creatorcontrib><creatorcontrib>Kasthuri, S</creatorcontrib><title>A ProspectIve, OpeN-Label, Randomized Study Comparing EffIcacy and Safety of Teneligliptin VErsus Sitagliptin in Indian Patients with Inadequately Controlled Type 2 Diabetes Mellitus: INSITES Study</title><title>Journal of the Association of Physicians of India</title><addtitle>J Assoc Physicians India</addtitle><description>Teneligliptin is widely prescribed dipeptidyl peptidase-4 inhibitor (DPP-4i) in India because of its economical pricing. However, there is no headto-head trial comparing teneligliptin with any other DPP-4i in Indian setting. We evaluated the efficacy and safety of teneligliptin versus sitagliptin as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes mellitus (T2DM).
This prospective, open-label, randomized, active-controlled study enrolled 76 patients (1:1) at 2 centres. Patients received teneligliptin 20 mg or sitagliptin 100 mg orally once daily for 12 weeks as add-on to ongoing metformin or sulfonylurea therapy. Primary endpoint was mean change in glycosylated hemoglobin (HbA1c) from baseline at week 12.
Both arms were comparable (p>0.05) at baseline in terms of age, gender, metformin daily dose, sulfonylurea use, HbA1c, fasting and postprandial blood glucose (FBG and PPBG). At the end of 12 weeks, statistically significant reductions were observed in both teneligliptin and sitagliptin arms in HbA1c (-1.19 ± 1.16% p<0.0001 and -0.92 ± 0.95%, p<0.0001), in FBG (-28.3 ± 63.0 mg/dL, p= 0.01 and -22.9 ± 47.4 mg/dL, p=0.006) and PPBG (-41.3 ± 85.4 mg/dL, p=0.006 and -54.7 ± 85.6 mg/dL, p=0.0005). The reductions in all glycemic parameters were similar between the arms. Both gliptins were well-tolerated with no difference in the number of adverse events. There was no change in QT/QTc intervals or other ECG parameters at week 12 in both arms. In post-hoc comparison, percentage of patients achieving target HbA1c <7% (as per American Diabetes Association guidelines) at week 12 favored teneligliptin arm over sitagliptin arm (33.3% vs. 19.4% patients).
Teneligliptin provided similar glycemic control as compared to sitagliptin and reduced HbA1c, FBG and PPBG values significantly within 12 weeks of treatment. Both gliptins were found to be safe and well-tolerated in Indian patients with T2DM.</description><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Dipeptidyl-Peptidase IV Inhibitors - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Humans</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>India</subject><subject>Prospective Studies</subject><subject>Pyrazoles - therapeutic use</subject><subject>Sitagliptin Phosphate - therapeutic use</subject><subject>Thiazolidines - therapeutic use</subject><issn>0004-5772</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1UEFOwzAQzAFEofAFtEcOjeTEaVJzQ6VApNJWpHCtHHtTjBwnxA4o_I9_YQSVVlppZnZnNEfBKSEkCadZFo-CM2vfCKGM0vgkGNFomkVJMj0Nvm9g0zW2ReHyD5zAusVVuOQl6gk8cSObWn2hhML1coB5U7e8U2YPi6rKBRcDeAkUvEI3QFPBFg1qtdeqdcrAy6KzvYVCOX6A_ORGKm5gw51C4yx8KvfqQS7xvecO9a-NcV2jtffdDi1CDLfKJ3Jo4RG1Vq6315Cviny7KP6SnQfHFdcWL_73OHi-W2znD-FyfZ_Pb5ZhG8WpC0WSRLGoZFSmIp2RjJGsmiZsRqms0pIxwZNZKUrBRJp4npNM8hnKNGUUoygjdBxc_f1tu-a9R-t2tbLCZ-IGm97u4pgxX3fmD8bB5b-0L2uUu7ZTNe-G3aF6-gOUTIE4</recordid><startdate>201910</startdate><enddate>201910</enddate><creator>Mohan, V</creator><creator>Ramu, M</creator><creator>Poongothai, S</creator><creator>Kasthuri, S</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>201910</creationdate><title>A ProspectIve, OpeN-Label, Randomized Study Comparing EffIcacy and Safety of Teneligliptin VErsus Sitagliptin in Indian Patients with Inadequately Controlled Type 2 Diabetes Mellitus: INSITES Study</title><author>Mohan, V ; Ramu, M ; Poongothai, S ; Kasthuri, S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p126t-c4412cfd1b6c6807907f549833df6b99ca48bcbc9c64680a07da8ed6693e11703</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Dipeptidyl-Peptidase IV Inhibitors - therapeutic use</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination</topic><topic>Humans</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>India</topic><topic>Prospective Studies</topic><topic>Pyrazoles - therapeutic use</topic><topic>Sitagliptin Phosphate - therapeutic use</topic><topic>Thiazolidines - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mohan, V</creatorcontrib><creatorcontrib>Ramu, M</creatorcontrib><creatorcontrib>Poongothai, S</creatorcontrib><creatorcontrib>Kasthuri, S</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of the Association of Physicians of India</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mohan, V</au><au>Ramu, M</au><au>Poongothai, S</au><au>Kasthuri, S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A ProspectIve, OpeN-Label, Randomized Study Comparing EffIcacy and Safety of Teneligliptin VErsus Sitagliptin in Indian Patients with Inadequately Controlled Type 2 Diabetes Mellitus: INSITES Study</atitle><jtitle>Journal of the Association of Physicians of India</jtitle><addtitle>J Assoc Physicians India</addtitle><date>2019-10</date><risdate>2019</risdate><volume>67</volume><issue>10</issue><spage>14</spage><epage>19</epage><pages>14-19</pages><issn>0004-5772</issn><abstract>Teneligliptin is widely prescribed dipeptidyl peptidase-4 inhibitor (DPP-4i) in India because of its economical pricing. However, there is no headto-head trial comparing teneligliptin with any other DPP-4i in Indian setting. We evaluated the efficacy and safety of teneligliptin versus sitagliptin as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes mellitus (T2DM).
This prospective, open-label, randomized, active-controlled study enrolled 76 patients (1:1) at 2 centres. Patients received teneligliptin 20 mg or sitagliptin 100 mg orally once daily for 12 weeks as add-on to ongoing metformin or sulfonylurea therapy. Primary endpoint was mean change in glycosylated hemoglobin (HbA1c) from baseline at week 12.
Both arms were comparable (p>0.05) at baseline in terms of age, gender, metformin daily dose, sulfonylurea use, HbA1c, fasting and postprandial blood glucose (FBG and PPBG). At the end of 12 weeks, statistically significant reductions were observed in both teneligliptin and sitagliptin arms in HbA1c (-1.19 ± 1.16% p<0.0001 and -0.92 ± 0.95%, p<0.0001), in FBG (-28.3 ± 63.0 mg/dL, p= 0.01 and -22.9 ± 47.4 mg/dL, p=0.006) and PPBG (-41.3 ± 85.4 mg/dL, p=0.006 and -54.7 ± 85.6 mg/dL, p=0.0005). The reductions in all glycemic parameters were similar between the arms. Both gliptins were well-tolerated with no difference in the number of adverse events. There was no change in QT/QTc intervals or other ECG parameters at week 12 in both arms. In post-hoc comparison, percentage of patients achieving target HbA1c <7% (as per American Diabetes Association guidelines) at week 12 favored teneligliptin arm over sitagliptin arm (33.3% vs. 19.4% patients).
Teneligliptin provided similar glycemic control as compared to sitagliptin and reduced HbA1c, FBG and PPBG values significantly within 12 weeks of treatment. Both gliptins were found to be safe and well-tolerated in Indian patients with T2DM.</abstract><cop>India</cop><pmid>31571445</pmid><tpages>6</tpages></addata></record> |
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| subjects | Diabetes Mellitus, Type 2 - drug therapy Dipeptidyl-Peptidase IV Inhibitors - therapeutic use Double-Blind Method Drug Therapy, Combination Humans Hypoglycemic Agents - therapeutic use India Prospective Studies Pyrazoles - therapeutic use Sitagliptin Phosphate - therapeutic use Thiazolidines - therapeutic use |
| title | A ProspectIve, OpeN-Label, Randomized Study Comparing EffIcacy and Safety of Teneligliptin VErsus Sitagliptin in Indian Patients with Inadequately Controlled Type 2 Diabetes Mellitus: INSITES Study |
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