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
- Authors
- Rhee, E. J.; Lee, W. Y.; Yoon, K. H.; Yoo, S. J.; Lee, I. K.; Baik, S. H.; Kim, Y. K.; Lee, M. K.; Park, K. S.; Park, J. Y.; Cha, B. S.; Lee, H. W.; Min, K. W.; Bae, H. Y.; Kim, M. J.; Kim, J. A.; Kim, D. K.; Kim, S. W.
- Issue Date
- 12월-2010
- Publisher
- WILEY-BLACKWELL
- Keywords
- dose-finding study; DPP-IV inhibitor; monotherapy; type 2 diabetes
- Citation
- DIABETES OBESITY & METABOLISM, v.12, no.12, pp.1113 - 1119
- Indexed
- SCIE
SCOPUS
- Journal Title
- DIABETES OBESITY & METABOLISM
- Volume
- 12
- Number
- 12
- Start Page
- 1113
- End Page
- 1119
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/115242
- DOI
- 10.1111/j.1463-1326.2010.01303.x
- ISSN
- 1462-8902
- 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.
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