| Trial ID: | L7039 |
| Source ID: | NCT03194945
|
| Associated Drug: |
Csii Followed By Lina+Met
|
| Title: |
Effects of Sequential Treatment Based on Lina/MET After Short-term Intensive Insulin in Newly Diagnosed Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: CSII followed by Lina+MET|DRUG: CSII followed by Lina|DRUG: CSII followed by MET|DRUG: CSII alone
|
| Outcome Measures: |
Primary: proportion of subjects with optimal glycemic control, proportion of patients achieving glycosylated hemoglobin A1C \<7% at the end of sequential treatment in each treatment group., 48 weeks | Secondary: proportion of subjects with excellent glycemic control, proportion of patients achieving glycosylated hemoglobin A1C \<6.5% at the end of sequential treatment in each treatment group., 48 weeks|Change of β cell function, Differences in β-cell indicators among treatment arms at the end of study., 48 weeks|Change of insulin sensitivity, Differences in insulin sensitivity indicators among treatment arms at the end of study., 48 weeks|Incidence of adverse events, Differences in incidence of adverse events among treatment arms at the end of study., 48 weeks
|
| Sponsor/Collaborators: |
Sponsor: Sun Yat-sen University | Collaborators: The Seventh Affiliated Hospital of Sun Yat-sen University|Guangdong Provincial Hospital of Traditional Chinese Medicine|Guangdong Provincial People's Hospital|The First Affiliated Hospital with Nanjing Medical University|Dongguan People's Hospital|Clifford Hospital|Guangzhou Panyu Central Hospital|Nanfang Hospital, Southern Medical University|Chinese PLA General Hospital|Peking University People's Hospital|Shanghai 10th People's Hospital|Shanghai Changzheng Hospital|Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University|Huizhou Municipal Central Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
412
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2017-11-01
|
| Completion Date: |
2022-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-06-18
|
| Locations: |
endocrinology department of the first affiliated hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510080, China
|
| URL: |
https://clinicaltrials.gov/show/NCT03194945
|
