| Trial ID: | L2980 |
| Source ID: | NCT03196362
|
| Associated Drug: |
Pioglitazone + Metformin
|
| Title: |
Impacts of PIO/MET Following Short-term Intensive Insulin Treatment in Newly Diagnosed Type 2 Diabetes
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Pioglitazone + Metformin|DRUG: Placebo Oral Tablet
|
| Outcome Measures: |
Primary: Remission rate, Remission rate at the end of the study in each group, 48 weeks | Secondary: β-cell function, Difference in β-cell secretion capacity at the end of follow up between treatment groups, 48 weeks|Insulin sensitivity, Difference in insulin sensitivity at the end of follow up between treatment groups, 48 weeks|glycemic control, proportion of patients who achieve A1C\<7% at the end of follow-up, 48 weeks|Adverse events, difference in AEs at the end of follow-up between treatment groups, 48 weeks
|
| Sponsor/Collaborators: |
Sponsor: Sun Yat-sen University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-12-01
|
| Completion Date: |
2018-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2017-06-22
|
| Locations: |
endocrinology department of the first affiliated hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510080, China
|
| URL: |
https://clinicaltrials.gov/show/NCT03196362
|
