| Trial ID: | L5397 |
| Source ID: | NCT05545800
|
| Associated Drug: |
Metformin+Empagliflozin+Insulin Glargine
|
| Title: |
Efficacy and Safety Of Different Regimens In Patients With Type 2 Diabetes Receiving Intensive Insulin Therapy
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: metformin+empagliflozin+insulin glargine|DRUG: IDegLira|DRUG: premixed insulin analogues
|
| Outcome Measures: |
Primary: Mean Change From Baseline in HbA1c, mean change from baseline in HbA1c after 3-months of treatment., Month 0 to 3|Percentage of patients achieving HbA1c <7%, Percentage of patients achieving HbA1c \<7% after 3-months of treatment., Month 0 to 3|Amplitude of glycemic excursions, Amplitude of glycemic excursions from month 0 to 3, Month 0 to 3 | Secondary: Percentage of hypoglycemia incidence, Percentage of hypoglycemia incidence from month 0 to 3, Month 0 to 3|Percentage of adverse events, Percentage of adverse events from month 0 to 3, Month 0 to 3
|
| Sponsor/Collaborators: |
Sponsor: Xiangya Hospital of Central South University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
78
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-09-01
|
| Completion Date: |
2024-06-01
|
| Results First Posted: |
|
| Last Update Posted: |
2022-09-19
|
| Locations: |
Xiangya Hospital of Central South University, Changsha, Hunan, 410008, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05545800
|
