Type 2 Diabetes
Conditions
Keywords
type 2 diabetes
Brief summary
This is a randomized, open-label, active-controlled, parallel, multicenter, phase IV clinical study evaluating the efficacy and safety of switching Metformin+SGLT2-i+DPP4-i to Metformin+SGLT2-i+TZD in patients with type 2 diabetes.
Interventions
DRUGMetformin
The dosage and dose frequency are maintained as they were before the screening.
DRUGDapagliflozin/Pioglitazone
Dapagliflozin 10mg/Pioglitazone 30mg QD
DRUGDapagliflozin/Sitagliptin
Dapagliflozin 10mg/Sitagliptin 100mg QD
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has voluntarily agreed to participate in this clinical trial. * Adults over 19 years of age * Diagnosed with type 2 diabetes
Exclusion criteria
* Has severe renal and liver disorders * Has type 1 diabetes * Those who are participating or have participated in other clinical trials and administered their investigational products within 8 weeks before the screening date for this study * Those who are deemed ineligible to participate in the study by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c (%) change at 24 weeks compared to the baseline (Visit 2) | From baseline to end of treatment at 24 weeks | The mean change of HbA1c at 24 weeks compared to the baseline (Visit 2) is evaluated. |
Countries
South Korea
Contacts
Primary ContactOh
Outcome results
None listed