| Trial ID: | L5575 |
| Source ID: | NCT03458715
|
| Associated Drug: |
Sglt2 Inhibitor (Empagliflozin 25 Mg)
|
| Title: |
The Efficacy of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase-4 Inhibitor in Type 2 Diabetes Patients With Premix Insulin
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type2 Diabetes
|
| Interventions: |
DRUG: SGLT2 inhibitor (Empagliflozin 25 MG)|DRUG: DPP4 inhibitor (Linagliptin 5 MG)
|
| Outcome Measures: |
Primary: Glycated hemoglobin (HbA1c), change in glycated hemoglobin (HbA1c) in percentage from baseline to week 24, measurement at baseline, 12 week and 24 week | Secondary: Fasting blood glucose, change in fasting blood glucose in mg/dl from baseline to week 24, measurement at baseline, 12 week and 24 week|Postprandial blood glucose, change in postprandial blood glucose in mg/dl from baseline to week 24, measurement at baseline, 12 week and 24 week|Body weight, change in body weight in kilogram from baseline to week 24, measurement at baseline, 12 week and 24 week|Hypoglycemia event, documented hypoglycemia (glucose monitor \<70mg/dl with hypoglycemia associated symptoms) from baseline to week 24, recorded at 12 week and 24 week
|
| Sponsor/Collaborators: |
Sponsor: Mackay Memorial Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2017-09-21
|
| Completion Date: |
2018-11-21
|
| Results First Posted: |
|
| Last Update Posted: |
2018-03-08
|
| Locations: |
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, 10449, Taiwan
|
| URL: |
https://clinicaltrials.gov/show/NCT03458715
|
