Retrospective Diabetes Registry of Thai Patients with Type 2 Diabetes Mellitus on SGLT2 Inhibitor Therapy
Phase 4
Recruiting
- Conditions
- Diabetes type 2
- Registration Number
- TCTR20180820003
- Lead Sponsor
- AstraZeneca Thailand Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1250
Inclusion Criteria
1. Outpatient ≥ 18 years of age
2. Diagnosis of T2DM prior to the first prescription of SGLT2i
3. First prescription for SGLT2i between October 2014 and end of available of Ramathibodi, Chiang Mai University and Theptarin hospital data in April 2018, receiving SGLT2i at least 3 months.
Exclusion Criteria
1. Hypersensitivity to any SGLT2 inhibitor or any of the components in the formulation
2. Patients with other type of diabetes ie. Type 1 DM, gestational diabetes, etc
3. Patient who use SGLT2i for obesity indication
4. Severe medical condition that in the view of the investigator prohibits participation in the study e.g .cancer, end stage liver disease
5. Renal Function :<45 ml/min/1.73m²
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Description of patient characteristics at baseline, HbA1c, Weight and Blood pressure at baseline and day 0, month 3, month 6, month 12, month 18, month 24, month 30, month 36, month 42 or last consulta HbA1c, Weight and Blood pressure
- Secondary Outcome Measures
Name Time Method Other lab parameters For FPG and hypoglycemia day 0, 3, 6, 12, 18, 24, 30, 36, 48 and last visit. Others, day 0 and LV FPG, Lipid change, serum creatinine, eGFR, reaching goal proportion, hypoglycemia