Subgroup analysis of phase 3 studies of dulaglutide in Japanese patients with type 2 diabetes

Onishi, Yukiko; Oura, Tomonori; Nishiyama, Hiroshi; Ohyama, Seiichi; Takeuchi, Masakazu; Iwamoto, Noriyuki

doi:10.1507/endocrj.ej15-0518

Cited by 25 publications

(42 citation statements)

References 15 publications

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“…Patients with higher baseline HbA1c had significantly greater HbA1c reductions following the 12‐week treatment period. Similar results have been reported in subgroup analyses of other oral hypoglycemic agents (OHAs) . Specifically, greater reductions in HbA1c were observed in patients with higher baseline HbA1c after 26 weeks liraglutide treatment compared with patients with lower HbA1c at baseline .…”

Section: Discussionsupporting

confidence: 79%

Evaluation of the Chinese herbal medicine Jinlida in type 2 diabetes patients based on stratification: Results of subgroup analysis from a 12‐week trial

Tian

Lian

Yang

et al. 2017

Journal of Diabetes

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Section: Discussionsupporting

confidence: 79%

Evaluation of the Chinese herbal medicine Jinlida in type 2 diabetes patients based on stratification: Results of subgroup analysis from a 12‐week trial

Tian

Lian

Yang

et al. 2017

Journal of Diabetes

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“…Diabetic patients were additionally divided into subgroups according to level of metabolic control. HbA1c = 8.5%, similar to the studies by Onishi et al, [38] Yoon et al, [39] Christie et al, [40] and Cakmak et al, [41] was regarded as a reference value. In this way 4 subgroups were created: with good metabolic control HbA1c ≤8.5%, subgroup D1-a, n = 14, mean HbA1c 7.45 ± 1.01%; subgroup D2-a, n = 14, mean HbA1c 7.37 ± 0.78% and poor metabolic control HbA1c >8.5%, subgroup D1-b, n = 16, mean HbA1c 9.75 ± 0.95%; subgroup D2-b, n = 15 mean HbA1c 9.45 ± 0.72%.…”

Section: Methodssupporting

confidence: 61%

Salivary lactate dehydrogenase and aminotransferases in diabetic patients

Malicka

Skośkiewicz−Malinowska

Kaczmarek

2016

Medicine

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Diabetes mellitus (DM) is a group of metabolic diseases resulting from impaired insulin secretion and/or action. DM is characterized by hyperglycemia that can lead to the dysfunction or damage of organs, including the salivary glands.The aim of this study was to compare the levels of salivary lactate dehydrogenase (LDH), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) in diabetic patients.The study was approved by the Bioethics Committee of Wroclaw Medical University (Poland). The study comprised 90 adults of both sexes, aged 21 to 57 years. The patients were divided into 3 groups: type 1 diabetics (D1), type 2 diabetics (D2), and a healthy control group (C). Each group consisted of 30 age- and sex-matched subjects. Total protein (P, by Lowry method), LDH, AST, ALT (with Alpha Diagnostics kits), and salivary flow rate were measured in unstimulated mixed saliva. The level of glycosylated hemoglobin (HbA1c) was measured with DCA 2000 Reagent Kit. The obtained data were analyzed using the Mann–Whitney U test and the Spearman rank at a significance level of P < 0.05 with the use of STATISTICA 9.0 software.In comparison with C, D1 presented a significantly higher activity of LDH (P < 0.001), AST (P < 0.001), and ALT (P < 0.01), whereas D2 indicated higher levels of LDH (P < 0.001) and ALT (P < 0.05) compared with C. Comparing D1 to D2, approximately 3-fold higher activity of AST (P < 0.01) and approximately 4.5-fold higher activity of ALT (P < 0.01) was observed.Higher levels of salivary LDH, AST, and ALT in D1 compared with D2 and C confirm that salivary glands of D1 might be attributed to autoimmunological damage associated with the pathomechanism of DM.

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“…In a subgroup analysis of 855 Japanese patients with T2D treated with dulaglutide 0.75 mg for up to 26 weeks in the 3 phase 3 studies, similar changes in HbA1c were observed in males and females; females had significantly greater weight loss and a significantly higher incidence of nausea than males [11]. In order to further evaluate the clinical responses in Japanese patients with T2D based on sex, we compared the efficacy and safety of dulaglutide 0.75 mg and 2 comparator drugs, another GLP-1 receptor agonist (liraglutide) and insulin glargine, between males and females using data from 2 randomized, controlled phase 3 studies.…”

Section: Analysis Methodsmentioning

confidence: 83%

Analysis of efficacy and safety of dulaglutide 0.75 mg stratified by sex in patients with type 2 diabetes in 2 randomized, controlled phase 3 studies in Japan

et al. 2017

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Subgroup analysis of phase 3 studies of dulaglutide in Japanese patients with type 2 diabetes

Cited by 25 publications

References 15 publications

Evaluation of the Chinese herbal medicine Jinlida in type 2 diabetes patients based on stratification: Results of subgroup analysis from a 12‐week trial

Evaluation of the Chinese herbal medicine Jinlida in type 2 diabetes patients based on stratification: Results of subgroup analysis from a 12‐week trial

Salivary lactate dehydrogenase and aminotransferases in diabetic patients

Analysis of efficacy and safety of dulaglutide 0.75 mg stratified by sex in patients with type 2 diabetes in 2 randomized, controlled phase 3 studies in Japan

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