A multicentre, multinational, randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of gemigliptin (LC15-0444) in patients with type 2 diabetes

S. J. Yang, K. W. Min, S. K. Gupta, J. Y. Park, V. K. Shivane, S. U. Pitale, P. K. Agarwal, A. Sosale, P. Gandhi, M. Dharmalingam, V. Mohan, U. Mahesh, D. M. Kim, Y. S. Kim, J. A. Kim, P. K. Kim, Sei-Hyun Baik

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

Aim: This study was designed to assess the efficacy and safety of the dipeptidyl peptidase IV inhibitor gemigliptin (LC15-0444) 50mg versus placebo in patients with type 2 diabetes. Methods: We conducted a 24-week, randomized, double-blind, placebo-controlled phase III trial in 182 patients (74 from Korea and 108 from India) with type 2 diabetes. After an initial 2weeks of a diet and exercise programme followed by 2weeks of a single-blind placebo run-in period, eligible patients were randomized to gemigliptin 50mg or placebo, receiving the assigned treatment for 24weeks. HbA1c and fasting plasma glucose (FPG) were measured periodically, and oral glucose tolerance test was performed at baseline and weeks 12 and 24. Results: At week 24, gemigliptin treatment led to significant reductions in HbA1c measurements compared to placebo (adjust mean after subtracting the placebo effect size: -0.71%, 95% confidence interval: -1.04 to -0.37%). A significantly greater proportion of patients achieved an HbA1c <7% with gemigliptin than with placebo. The placebo-subtracted FPG change from baseline at week 24 was -19.80mg/dl. The overall incidence rates for adverse events were similar in the gemigliptin and placebo groups. Conclusions: This study showed the efficacy and safety of gemigliptin 50mg administered once daily as a monotherapy for type 2 diabetes patients.

Original languageEnglish
Pages (from-to)410-416
Number of pages7
JournalDiabetes, Obesity and Metabolism
Volume15
Issue number5
DOIs
Publication statusPublished - 2013 May 1

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Type 2 Diabetes Mellitus
Inpatients
Placebos
Safety
Fasting
Dipeptidyl-Peptidase IV Inhibitors
Glucose
Placebo Effect
LC15-0444
Korea
Glucose Tolerance Test
India
Confidence Intervals
Exercise
Diet
Incidence
Therapeutics

Keywords

  • DPP-IV inhibitor
  • Gemigliptin
  • LC15-0444
  • Type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

A multicentre, multinational, randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of gemigliptin (LC15-0444) in patients with type 2 diabetes. / Yang, S. J.; Min, K. W.; Gupta, S. K.; Park, J. Y.; Shivane, V. K.; Pitale, S. U.; Agarwal, P. K.; Sosale, A.; Gandhi, P.; Dharmalingam, M.; Mohan, V.; Mahesh, U.; Kim, D. M.; Kim, Y. S.; Kim, J. A.; Kim, P. K.; Baik, Sei-Hyun.

In: Diabetes, Obesity and Metabolism, Vol. 15, No. 5, 01.05.2013, p. 410-416.

Research output: Contribution to journalArticle

Yang, SJ, Min, KW, Gupta, SK, Park, JY, Shivane, VK, Pitale, SU, Agarwal, PK, Sosale, A, Gandhi, P, Dharmalingam, M, Mohan, V, Mahesh, U, Kim, DM, Kim, YS, Kim, JA, Kim, PK & Baik, S-H 2013, 'A multicentre, multinational, randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of gemigliptin (LC15-0444) in patients with type 2 diabetes', Diabetes, Obesity and Metabolism, vol. 15, no. 5, pp. 410-416. https://doi.org/10.1111/dom.12042
Yang, S. J. ; Min, K. W. ; Gupta, S. K. ; Park, J. Y. ; Shivane, V. K. ; Pitale, S. U. ; Agarwal, P. K. ; Sosale, A. ; Gandhi, P. ; Dharmalingam, M. ; Mohan, V. ; Mahesh, U. ; Kim, D. M. ; Kim, Y. S. ; Kim, J. A. ; Kim, P. K. ; Baik, Sei-Hyun. / A multicentre, multinational, randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of gemigliptin (LC15-0444) in patients with type 2 diabetes. In: Diabetes, Obesity and Metabolism. 2013 ; Vol. 15, No. 5. pp. 410-416.
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abstract = "Aim: This study was designed to assess the efficacy and safety of the dipeptidyl peptidase IV inhibitor gemigliptin (LC15-0444) 50mg versus placebo in patients with type 2 diabetes. Methods: We conducted a 24-week, randomized, double-blind, placebo-controlled phase III trial in 182 patients (74 from Korea and 108 from India) with type 2 diabetes. After an initial 2weeks of a diet and exercise programme followed by 2weeks of a single-blind placebo run-in period, eligible patients were randomized to gemigliptin 50mg or placebo, receiving the assigned treatment for 24weeks. HbA1c and fasting plasma glucose (FPG) were measured periodically, and oral glucose tolerance test was performed at baseline and weeks 12 and 24. Results: At week 24, gemigliptin treatment led to significant reductions in HbA1c measurements compared to placebo (adjust mean after subtracting the placebo effect size: -0.71{\%}, 95{\%} confidence interval: -1.04 to -0.37{\%}). A significantly greater proportion of patients achieved an HbA1c <7{\%} with gemigliptin than with placebo. The placebo-subtracted FPG change from baseline at week 24 was -19.80mg/dl. The overall incidence rates for adverse events were similar in the gemigliptin and placebo groups. Conclusions: This study showed the efficacy and safety of gemigliptin 50mg administered once daily as a monotherapy for type 2 diabetes patients.",
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AU - Min, K. W.

AU - Gupta, S. K.

AU - Park, J. Y.

AU - Shivane, V. K.

AU - Pitale, S. U.

AU - Agarwal, P. K.

AU - Sosale, A.

AU - Gandhi, P.

AU - Dharmalingam, M.

AU - Mohan, V.

AU - Mahesh, U.

AU - Kim, D. M.

AU - Kim, Y. S.

AU - Kim, J. A.

AU - Kim, P. K.

AU - Baik, Sei-Hyun

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N2 - Aim: This study was designed to assess the efficacy and safety of the dipeptidyl peptidase IV inhibitor gemigliptin (LC15-0444) 50mg versus placebo in patients with type 2 diabetes. Methods: We conducted a 24-week, randomized, double-blind, placebo-controlled phase III trial in 182 patients (74 from Korea and 108 from India) with type 2 diabetes. After an initial 2weeks of a diet and exercise programme followed by 2weeks of a single-blind placebo run-in period, eligible patients were randomized to gemigliptin 50mg or placebo, receiving the assigned treatment for 24weeks. HbA1c and fasting plasma glucose (FPG) were measured periodically, and oral glucose tolerance test was performed at baseline and weeks 12 and 24. Results: At week 24, gemigliptin treatment led to significant reductions in HbA1c measurements compared to placebo (adjust mean after subtracting the placebo effect size: -0.71%, 95% confidence interval: -1.04 to -0.37%). A significantly greater proportion of patients achieved an HbA1c <7% with gemigliptin than with placebo. The placebo-subtracted FPG change from baseline at week 24 was -19.80mg/dl. The overall incidence rates for adverse events were similar in the gemigliptin and placebo groups. Conclusions: This study showed the efficacy and safety of gemigliptin 50mg administered once daily as a monotherapy for type 2 diabetes patients.

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KW - Gemigliptin

KW - LC15-0444

KW - Type 2 diabetes

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