title: Phase III Study on Efficacy and Safety of Triple Combination (Exenatide/Metformin/Biphasic Insulin Aspart) Therapy for Type 2 Diabetes Mellitus.
abstract: Exenatide, metformin (MET), and biphasic insulin aspart 30 (BIA30) have been widely used in the treatment of patients with type 2 diabetes mellitus (T2DM); however, each of these medications has significant adverse effects, which limit their utilization. This study aimed to evaluate the efficacy and safety of triple combination (exenatide/metformin/biphasic insulin aspart) therapy for T2DM. Two hundred patients with poorly controlled T2DM were randomly divided into the low-dose (0.5 μg exenatide, 0.05 U·kg·d BIA30, and 0.01 g MET twice daily) and normal-dose (2 μg exenatide, 0.2 U·kg·d BIA30, and 0.05 g MET twice daily) groups for 48 weeks of treatment. Of note, 82 and 90 individuals from the low-dose and normal-dose groups, respectively, completed the study. The levels of adiponectin, C-reactive protein, tumor necrosis factor-α, and resistin were measured. The normal-dose treatment was more effective at lowering hemoglobin A1c levels than the low-dose therapy (HbA1c changes of -2.5 ± 0.19% and -0.8 ± 0.07%, respectively) after 48 weeks. The maximum weight decrease was 0.9 kg in the low-dose group and 4.0 kg in the normal-dose group. The triple combination therapy increased the levels of insulin sensitivity and adiponectin and reduced the levels of C-reactive protein, resistin, and tumor necrosis factor-α. No significant difference in the adverse effects was found between the low-dose and normal-dose groups (P > 0.05). In conclusion, the investigated triple combination therapy for T2MD is therefore an effective and safe therapeutic strategy.
authors: Comprehensive Internal Medicine, Beijing Xiaotangshan Hospital, Beijing, China.
authors: Ke
authors: K
authors: Su
authors: General Department, Beijing Xiaotangshan Hospital, Beijing, China.
authors: Chunmei
authors: C
authors: Lv
authors: Endocrinology Department, Shandong Yanzhou Mining Group General Hospital, Jining, China.
authors: Zongwen
authors: Z
authors: Ji
authors: Comprehensive Internal Medicine, Beijing Xiaotangshan Hospital, Beijing, China.
authors: Yishu
authors: Y
authors: Wang
authors: Nephrology Department, China-Japan Friendship Hospital, Beijing, China.
authors: Haifeng
authors: H
authors: Wang
authors: Departments of Outpatient and.
authors: Ying
authors: Y
authors: Bai
authors: Nutritional, Beijing Xiaotangshan Hospital, Beijing, China.
authors: Yaping
authors: Y
authors: Liu
mesh_terms: D052242:Adiponectin / Q000097:blood; D000368:Aged; D061265:Biphasic Insulins / Q000008:administration & dosage / Q000009:adverse effects; D001786:Blood Glucose / Q000187:drug effects*; D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D000077270:Exenatide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D061267:Insulin Aspart / Q000008:administration & dosage / Q000009:adverse effects; D007336:Insulin, Isophane / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects*
chemical_list: D052242:Adiponectin; D061265:Biphasic Insulins; D001786:Blood Glucose; D004338:Drug Combinations; D000077270:Exenatide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061267:Insulin Aspart; D007336:Insulin, Isophane; D008687:Metformin; C499918:ADIPOQ protein, human; C517652:hemoglobin A1c protein, human; C557564:insulin aspart, insulin aspart protamine drug combination 30:70