A multicenter, randomized, placebo-controlled, double-blind phase II trial evaluating the optimal dose, efficacy and safety of LC 15-0444 in patients with type 2 diabetes
DC Field | Value | Language |
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dc.contributor.author | Rhee, E. J. | - |
dc.contributor.author | Lee, W. Y. | - |
dc.contributor.author | Yoon, K. H. | - |
dc.contributor.author | Yoo, S. J. | - |
dc.contributor.author | Lee, I. K. | - |
dc.contributor.author | Baik, S. H. | - |
dc.contributor.author | Kim, Y. K. | - |
dc.contributor.author | Lee, M. K. | - |
dc.contributor.author | Park, K. S. | - |
dc.contributor.author | Park, J. Y. | - |
dc.contributor.author | Cha, B. S. | - |
dc.contributor.author | Lee, H. W. | - |
dc.contributor.author | Min, K. W. | - |
dc.contributor.author | Bae, H. Y. | - |
dc.contributor.author | Kim, M. J. | - |
dc.contributor.author | Kim, J. A. | - |
dc.contributor.author | Kim, D. K. | - |
dc.contributor.author | Kim, S. W. | - |
dc.date.accessioned | 2021-09-07T22:34:12Z | - |
dc.date.available | 2021-09-07T22:34:12Z | - |
dc.date.created | 2021-06-14 | - |
dc.date.issued | 2010-12 | - |
dc.identifier.issn | 1462-8902 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/115242 | - |
dc.description.abstract | Methods: This study was a double-blind, randomized, multicenter and parallel-group, dose-range finding study. We enrolled 145 patients (91 men and 54 women) with a median age of 53 years and a median body mass index of 25.1 kg/m2. The median baseline fasting plasma glucose (FPG) was 8.1 mmol/l, the median HbA1c was 7.9% and the median time since the diagnosis of diabetes was 3 years. After 2 weeks of an exercise/diet programme followed by 2 weeks of a placebo period, the subjects were randomized to one of the four following groups for a 12-week active treatment period: placebo and 50, 100 or 200 mg of LC15-0444. Results: All three doses of LC15-0444 significantly reduced the HbA1c from baseline compared to the placebo group (-0.06 vs. -0.98, -0.74 and -0.78% in the placebo and 50, 100 and 200 mg groups, respectively), without a significant difference between the doses. Subjects with a higher baseline HbA1c (>= 8.5%) had a greater reduction in HbA1c. Insulin secretory function, as assessed using homeostasis model assessment-beta cell, C-peptide and the insulinogenic index, improved significantly with LC15-0444 treatment. Insulin sensitivity, as assessed using homeostasis model assessment-insulin resistance, also improved significantly after 12 weeks of treatment. The 50 and 200 mg groups had significantly reduced total cholesterol and low-density lipoprotein cholesterol levels at 12 weeks compared to the placebo group. No dosage of LC15-0444 affected weight or waist circumference. The incidences of adverse events were similar in all study subjects. Conclusions: LC15-0444 monotherapy (50 mg for 12 weeks) improved the HbA1c, FPG level, oral glucose tolerance test results, beta-cell function and insulin sensitivity measures, and was well tolerated in Korean subjects with type 2 diabetes. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | WILEY-BLACKWELL | - |
dc.subject | DIPEPTIDYL PEPTIDASE-4 INHIBITOR | - |
dc.subject | BETA-CELL FUNCTION | - |
dc.subject | IV INHIBITOR | - |
dc.subject | GLUCOSE-TOLERANCE | - |
dc.subject | ISLET FUNCTION | - |
dc.subject | SITAGLIPTIN | - |
dc.subject | VILDAGLIPTIN | - |
dc.subject | MONOTHERAPY | - |
dc.subject | MELLITUS | - |
dc.subject | PHARMACOKINETICS | - |
dc.title | A multicenter, randomized, placebo-controlled, double-blind phase II trial evaluating the optimal dose, efficacy and safety of LC 15-0444 in patients with type 2 diabetes | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Baik, S. H. | - |
dc.identifier.doi | 10.1111/j.1463-1326.2010.01303.x | - |
dc.identifier.scopusid | 2-s2.0-77958577337 | - |
dc.identifier.wosid | 000283599200012 | - |
dc.identifier.bibliographicCitation | DIABETES OBESITY & METABOLISM, v.12, no.12, pp.1113 - 1119 | - |
dc.relation.isPartOf | DIABETES OBESITY & METABOLISM | - |
dc.citation.title | DIABETES OBESITY & METABOLISM | - |
dc.citation.volume | 12 | - |
dc.citation.number | 12 | - |
dc.citation.startPage | 1113 | - |
dc.citation.endPage | 1119 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Endocrinology & Metabolism | - |
dc.relation.journalWebOfScienceCategory | Endocrinology & Metabolism | - |
dc.subject.keywordPlus | DIPEPTIDYL PEPTIDASE-4 INHIBITOR | - |
dc.subject.keywordPlus | BETA-CELL FUNCTION | - |
dc.subject.keywordPlus | IV INHIBITOR | - |
dc.subject.keywordPlus | GLUCOSE-TOLERANCE | - |
dc.subject.keywordPlus | ISLET FUNCTION | - |
dc.subject.keywordPlus | SITAGLIPTIN | - |
dc.subject.keywordPlus | VILDAGLIPTIN | - |
dc.subject.keywordPlus | MONOTHERAPY | - |
dc.subject.keywordPlus | MELLITUS | - |
dc.subject.keywordPlus | PHARMACOKINETICS | - |
dc.subject.keywordAuthor | dose-finding study | - |
dc.subject.keywordAuthor | DPP-IV inhibitor | - |
dc.subject.keywordAuthor | monotherapy | - |
dc.subject.keywordAuthor | type 2 diabetes | - |
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