Comprehensive Evaluation of Combination Therapy with Basal Insulin and Either Lixisenatide or Vildagliptin in Japanese Patients with Type 2 Diabetes: ... View Full Text


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Article Info

DATE

2018-09-11

AUTHORS

Natsu Otowa-Suematsu, Kazuhiko Sakaguchi, Tomoaki Nakamura, Kenta Hara, Minoru Kishi, Naoko Hashimoto, Kazuki Yokota, Hiroshi Yoshino, Yasuo Kuroki, Tomoko Nishiumi, Anna Sou, Hisako Komada, Yuko Okada, Yushi Hirota, Yoshikazu Tamori, Wataru Ogawa

ABSTRACT

INTRODUCTION: We comprehensively evaluated the effects of combination therapy with insulin glargine and the incretin-based drugs lixisenatide or vildagliptin in Japanese patients with type 2 diabetes. METHODS: In this 12-week, randomized, open-label, parallel-group, multicenter study (GLP-ONE Kobe), the incretin-based drug sitagliptin was randomly switched to lixisenatide (20 μg/day, n = 18) or vildagliptin (100 mg/day, n = 20) in patients with inadequate glycemic control despite combination therapy with insulin glargine and sitagliptin. The dose of insulin glargine was titrated after the switch to maintain fasting blood glucose at approximately 110 mg/dL. The primary end points of the study were the change in glycosylated hemoglobin (HbA1c) level between before and 12 weeks after the treatment switch, the proportion of patients achieving an HbA1c level below 7.0%, and the postprandial increase in glucose concentration as assessed by self-monitoring of blood glucose. RESULTS: The change in HbA1c level from baseline to 12 weeks did not differ significantly between the lixisenatide and vildagliptin groups (- 0.6 ± 0.7% and - 0.6 ± 1.2%, respectively, P = 0.920). Neither the proportion of patients achieving an HbA1c level below 7.0% nor the postprandial increase in glucose concentration was different between two groups. Body weight and serum low density lipoprotein (LDL) cholesterol level decreased significantly in the lixisenatide and vildagliptin groups, respectively. Both drugs were associated with mild gastrointestinal symptoms but not with severe hypoglycemia. Vildagliptin was associated with elevation of serum aspartate transaminase. Treatment satisfaction as assessed with the Diabetes Treatment Satisfaction Questionnaire did not differ significantly between the two groups. CONCLUSION: The combinations of basal insulin and either lixisenatide or vildagliptin have similar efficacies with regard to improvement of glycemic control. TRIAL REGISTRATION: This trial has been registered with UMIN (No. 000010769). More... »

PAGES

2067-2079

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s13300-018-0505-2

DOI

http://dx.doi.org/10.1007/s13300-018-0505-2

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1106915635

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30206903


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11 schema:description INTRODUCTION: We comprehensively evaluated the effects of combination therapy with insulin glargine and the incretin-based drugs lixisenatide or vildagliptin in Japanese patients with type 2 diabetes. METHODS: In this 12-week, randomized, open-label, parallel-group, multicenter study (GLP-ONE Kobe), the incretin-based drug sitagliptin was randomly switched to lixisenatide (20 μg/day, n = 18) or vildagliptin (100 mg/day, n = 20) in patients with inadequate glycemic control despite combination therapy with insulin glargine and sitagliptin. The dose of insulin glargine was titrated after the switch to maintain fasting blood glucose at approximately 110 mg/dL. The primary end points of the study were the change in glycosylated hemoglobin (HbA<sub>1c</sub>) level between before and 12 weeks after the treatment switch, the proportion of patients achieving an HbA<sub>1c</sub> level below 7.0%, and the postprandial increase in glucose concentration as assessed by self-monitoring of blood glucose. RESULTS: The change in HbA<sub>1c</sub> level from baseline to 12 weeks did not differ significantly between the lixisenatide and vildagliptin groups (- 0.6 ± 0.7% and - 0.6 ± 1.2%, respectively, P = 0.920). Neither the proportion of patients achieving an HbA<sub>1c</sub> level below 7.0% nor the postprandial increase in glucose concentration was different between two groups. Body weight and serum low density lipoprotein (LDL) cholesterol level decreased significantly in the lixisenatide and vildagliptin groups, respectively. Both drugs were associated with mild gastrointestinal symptoms but not with severe hypoglycemia. Vildagliptin was associated with elevation of serum aspartate transaminase. Treatment satisfaction as assessed with the Diabetes Treatment Satisfaction Questionnaire did not differ significantly between the two groups. CONCLUSION: The combinations of basal insulin and either lixisenatide or vildagliptin have similar efficacies with regard to improvement of glycemic control. TRIAL REGISTRATION: This trial has been registered with UMIN (No. 000010769).
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18 schema:keywords Diabetes Treatment Satisfaction Questionnaire
19 HbA
20 Japanese patients
21 Treatment Satisfaction Questionnaire
22 UMIN
23 aspartate transaminase
24 basal insulin
25 baseline
26 blood glucose
27 body weight
28 changes
29 cholesterol levels
30 combination
31 combination therapy
32 comprehensive evaluation
33 concentration
34 control
35 density lipoprotein cholesterol levels
36 diabetes
37 dose
38 drug sitagliptin
39 drugs
40 drugs lixisenatide
41 effect
42 efficacy
43 elevation
44 end point
45 evaluation
46 gastrointestinal symptoms
47 glargine
48 glucose
49 glucose concentration
50 glycemic control
51 group
52 hemoglobin levels
53 hypoglycemia
54 improvement
55 inadequate glycemic control
56 increase
57 incretin-based drug sitagliptin
58 incretin-based drugs lixisenatide
59 insulin
60 insulin glargine
61 levels
62 lipoprotein cholesterol levels
63 lixisenatide
64 low-density lipoprotein cholesterol levels
65 mild gastrointestinal symptoms
66 multicenter study
67 open label
68 parallel group
69 patients
70 point
71 postprandial increase
72 primary end point
73 proportion
74 proportion of patients
75 questionnaire
76 regard
77 satisfaction
78 satisfaction questionnaire
79 serum aspartate transaminase
80 serum low-density lipoprotein cholesterol levels
81 severe hypoglycemia
82 similar efficacy
83 sitagliptin
84 study
85 switch
86 symptoms
87 therapy
88 transaminase
89 treatment satisfaction
90 treatment switch
91 trials
92 type 2
93 type 2 diabetes
94 vildagliptin
95 vildagliptin group
96 weeks
97 weight
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