| Trial ID: | L3213 |
| Source ID: | NCT05164263
|
| Associated Drug: |
Empagliflozin
|
| Title: |
Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study
|
| Acronym: |
EASE
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type II Diabetes Mellitus|Efficacy, Self|Safety Issues
|
| Interventions: |
DRUG: Empagliflozin
|
| Outcome Measures: |
Primary: SAFETY and TOLERABILITY Outcomes, Frequency of adverse events, serious adverse events during the course of study follow-up. Percentage of patients who tolerate empagliflozin., 6 months | Secondary: Efficacy outcomes, Change from baseline in HbA1c% and fasting plasma glucose to the last-observation on treatment. Change from baseline in bodyweight \& other study parameters., 6 months
|
| Sponsor/Collaborators: |
Sponsor: Getz Pharma
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
156
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-04-01
|
| Completion Date: |
2025-03-31
|
| Results First Posted: |
|
| Last Update Posted: |
2023-02-06
|
| Locations: |
Umar Diabetes Foundation, Islamabad, Pakistan|NHSL, Colombo, Sri Lanka|NHK, Kandy, Sri Lanka
|
| URL: |
https://clinicaltrials.gov/show/NCT05164263
|
