| Trial ID: | L4757 |
| Source ID: | NCT02449603
|
| Associated Drug: |
Exenatide
|
| Title: |
Comparison of Exenatide vs. Biphasic Insulin Aspart 30 on Glucose Variability in Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Exenatide|DRUG: Biphasic insulin Aspart 30
|
| Outcome Measures: |
Primary: Change of mean amplitude of glycemic excursions, from baseline to Week 16 | Secondary: HbA1c, at baseline and Week 16|Hours of hypoglycemia as measured by continuous glucose monitoring system (CGMS), at baseline and Week 16|Blood pressure, at baseline and Week 16|Lipids, at baseline and Week 16|Body mass index, at baseline and Week 16|Waist circumference, at baseline and Week 16|Monocyte chemotactic protein-1 (MCP-1), at baseline and Week 16|High-sensitivity C-reactive protein (hs-CRP), at baseline and Week 16|Urinary albumin, at baseline and Week 16|Number of participants with adverse events/severe adverse events, from baseline to Week 16|Number of participants with clinical hypoglycemia, from baseline to Week 16
|
| Sponsor/Collaborators: |
Sponsor: Xijing Hospital | Collaborators: Air Force Military Medical University, China|First Affiliated Hospital Xi'an Jiaotong University|Second Affiliated Hospital of Xi'an Jiaotong University|Shaanxi Provincial People's Hospital|Chang'An Hospital|Xi'an Gaoxin Hospital|Xi'an Central Hospital|Shaanxi Aerospace Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
150
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-11
|
| Completion Date: |
2018-04
|
| Results First Posted: |
|
| Last Update Posted: |
2018-11-14
|
| Locations: |
Xijing Hospital, Fourth Military Medical university, Xi'an, Shaanxi, 710032, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02449603
|
