PMID- 27009108
OWN - NLM
STAT- MEDLINE
DCOM- 20161227
LR  - 20181202
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 17
DP  - 2016 Mar 24
TI  - Comparison of exenatide with biphasic insulin aspart 30 on glucose variability in 
      type 2 diabetes: study protocol for a randomized controlled trial.
PG  - 160
LID - 10.1186/s13063-016-1258-8 [doi]
LID - 160
AB  - BACKGROUND: Apart from the mean level of glycemic control, the extent of glucose 
      excursions is another important issue to consider in type 2 diabetes mellitus 
      (T2DM) management. Studies have showed that fluctuations of glucose seem to have 
      more deleterious effects than sustained hyperglycemia in the development of 
      diabetic complications as acute glucose swings activate the oxidative stress. 
      However, until now, no randomized controlled trials have been conducted with the 
      primary aim to evaluate glycemic fluctuation in the comparison between 
      twice-daily exenatide and other treatment paradigms (for example, biphasic 
      insulin aspart 30). METHODS/DESIGN: This multicenter, open-label, randomized, 
      parallel trial includes a 1-week screening period and a 16-week treatment period. 
      After the screening period, 150 patients with confirmed type 2 diabetes who are 
      treated with stable, maximum-tolerated doses of metformin will be randomly 
      assigned to one of two groups for antihyperglycemic therapies: exenatide and 
      biphasic insulin aspart 30. The treatment with exenatide will be initiated at a 
      low dose of 5 mug twice a day for 4 weeks and then titrated up to a standard dose 
      of 10 ug twice a day until the completion of the study. The adjustment of insulin 
      dose is instructed to achieve an optimal balance between glycemic control and the 
      risk of hypoglycemia as dictated by clinical practice. The primary outcome is the 
      absolute change of mean amplitude of glycemic excursion from baseline to week 16, 
      which is calculated based on a real-time continuous glucose monitoring system 
      (CGMS). DISCUSSION: This is the first randomized controlled trial using a CGMS to 
      evaluate glycemic fluctuation between twice-daily exenatide and insulin aspart 
      30, which will provide beneficial evidence of exenatide usage in patients with 
      T2DM. TRIAL REGISTRATION NUMBER: NCT02449603 . Date of registration: 11 May 2015.
FAU - Xu, Shaoyong
AU  - Xu S
AD  - Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, 
      169 Changle Road West, Xi'an, 710032, China.
FAU - Liu, Xiangyang
AU  - Liu X
AD  - Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, 
      169 Changle Road West, Xi'an, 710032, China.
FAU - Ming, Jie
AU  - Ming J
AD  - Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, 
      169 Changle Road West, Xi'an, 710032, China.
FAU - Ji, Qiuhe
AU  - Ji Q
AD  - Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, 
      169 Changle Road West, Xi'an, 710032, China. qiuheji@hotmail.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT02449603
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20160324
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Biomarkers)
RN  - 0 (Biphasic Insulins)
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Incretins)
RN  - 0 (Peptides)
RN  - 0 (Venoms)
RN  - 0 (insulin aspart, insulin aspart protamine drug combination 30:70)
RN  - 53027-39-7 (Insulin, Isophane)
RN  - 9P1872D4OL (Exenatide)
RN  - D933668QVX (Insulin Aspart)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Biomarkers/blood
MH  - Biphasic Insulins/adverse effects/*therapeutic use
MH  - Blood Glucose/*drug effects/metabolism
MH  - China
MH  - Clinical Protocols
MH  - Diabetes Mellitus, Type 2/blood/diagnosis/*drug therapy
MH  - Exenatide
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Incretins/adverse effects/*therapeutic use
MH  - Insulin Aspart/adverse effects/*therapeutic use
MH  - Insulin, Isophane/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Peptides/adverse effects/*therapeutic use
MH  - Pilot Projects
MH  - Research Design
MH  - Time Factors
MH  - Treatment Outcome
MH  - Venoms/adverse effects/*therapeutic use
MH  - Young Adult
PMC - PMC4806460
EDAT- 2016/03/25 06:00
MHDA- 2016/12/28 06:00
PMCR- 2016/03/24
CRDT- 2016/03/25 06:00
PHST- 2015/11/06 00:00 [received]
PHST- 2016/02/26 00:00 [accepted]
PHST- 2016/03/25 06:00 [entrez]
PHST- 2016/03/25 06:00 [pubmed]
PHST- 2016/12/28 06:00 [medline]
PHST- 2016/03/24 00:00 [pmc-release]
AID - 10.1186/s13063-016-1258-8 [pii]
AID - 1258 [pii]
AID - 10.1186/s13063-016-1258-8 [doi]
PST - epublish
SO  - Trials. 2016 Mar 24;17:160. doi: 10.1186/s13063-016-1258-8.