PMID- 26844723
OWN - NLM
STAT- MEDLINE
DCOM- 20190319
LR  - 20221207
IS  - 1536-3686 (Electronic)
IS  - 1075-2765 (Linking)
VI  - 25
IP  - 6
DP  - 2018 Nov/Dec
TI  - Phase III Study on Efficacy and Safety of Triple Combination 
      (Exenatide/Metformin/Biphasic Insulin Aspart) Therapy for Type 2 Diabetes 
      Mellitus.
PG  - e609-e616
LID - 10.1097/MJT.0000000000000431 [doi]
AB  - 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 mug exenatide, 0.05 U.kg.d BIA30, and 0.01 g MET twice daily) and 
      normal-dose (2 mug 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-alpha, 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-alpha. 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.
FAU - Su, Ke
AU  - Su K
AD  - Comprehensive Internal Medicine, Beijing Xiaotangshan Hospital, Beijing, China.
FAU - Lv, Chunmei
AU  - Lv C
AD  - General Department, Beijing Xiaotangshan Hospital, Beijing, China.
FAU - Ji, Zongwen
AU  - Ji Z
AD  - Endocrinology Department, Shandong Yanzhou Mining Group General Hospital, Jining, 
      China.
FAU - Wang, Yishu
AU  - Wang Y
AD  - Comprehensive Internal Medicine, Beijing Xiaotangshan Hospital, Beijing, China.
FAU - Wang, Haifeng
AU  - Wang H
AD  - Nephrology Department, China-Japan Friendship Hospital, Beijing, China.
FAU - Bai, Ying
AU  - Bai Y
AD  - Departments of Outpatient and.
FAU - Liu, Yaping
AU  - Liu Y
AD  - Nutritional, Beijing Xiaotangshan Hospital, Beijing, China.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Am J Ther
JT  - American journal of therapeutics
JID - 9441347
RN  - 0 (ADIPOQ protein, human)
RN  - 0 (Adiponectin)
RN  - 0 (Biphasic Insulins)
RN  - 0 (Blood Glucose)
RN  - 0 (Drug Combinations)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 0 (insulin aspart, insulin aspart protamine drug combination 30:70)
RN  - 53027-39-7 (Insulin, Isophane)
RN  - 9100L32L2N (Metformin)
RN  - 9P1872D4OL (Exenatide)
RN  - D933668QVX (Insulin Aspart)
SB  - IM
MH  - Adiponectin/blood
MH  - Aged
MH  - Biphasic Insulins/administration & dosage/adverse effects
MH  - Blood Glucose/*drug effects
MH  - Body Weight/drug effects
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Drug Combinations
MH  - Exenatide/administration & dosage/adverse effects
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/adverse effects
MH  - Insulin Aspart/administration & dosage/adverse effects
MH  - Insulin, Isophane/administration & dosage/adverse effects
MH  - Male
MH  - Metformin/administration & dosage/adverse effects
MH  - Middle Aged
MH  - Treatment Outcome
MH  - Weight Loss/*drug effects
EDAT- 2016/02/05 06:00
MHDA- 2019/03/20 06:00
CRDT- 2016/02/05 06:00
PHST- 2016/02/05 06:00 [pubmed]
PHST- 2019/03/20 06:00 [medline]
PHST- 2016/02/05 06:00 [entrez]
AID - 10.1097/MJT.0000000000000431 [doi]
PST - ppublish
SO  - Am J Ther. 2018 Nov/Dec;25(6):e609-e616. doi: 10.1097/MJT.0000000000000431.