| Trial ID: | L1853 |
| Source ID: | NCT02467920
|
| Associated Drug: |
Glargine + Exenatide
|
| Title: |
Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Aspart30 in T2DM
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: glargine + exenatide|DRUG: aspart 30
|
| Outcome Measures: |
Primary: the absolute change in HbA1c from baseline to 24-week endpoint of basal insulin glargine combination with exenatide bid vs. switching to aspart30 in type 2 diabetic patients inadequately controlled on premixed human insulin and metformin., from baseline to 24-week endpoint | Secondary: Change in HbA1c from baseline to 12 weeks endpoint, from baseline to 12 weeks endpoint|The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%, 12 weeks and 24 weeks|Fasting blood glucose, 12 weeks and 24 weeks|Daily insulin use, baseline, 12 weeks and 24 weeks|Change in body weight, from baseline to 12 and 24 weeks|The incidence and rate of hypoglycaemic events during the study, baseline, 12 weeks and 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Huazhong University of Science and Technology
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
349
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-08
|
| Completion Date: |
2017-12
|
| Results First Posted: |
|
| Last Update Posted: |
2018-11-14
|
| Locations: |
Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology, Wuhan, Hubei, 430000, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02467920
|
