Type2 Diabetes
Conditions
Brief summary
A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
Interventions
DRUGEvogliptin 5mg
Participants receive Evogliptin 5mg orally once a day
DRUGEvogliptin Placebo
Participants receive placebo to match Evogliptin 5mg orally once a day
DRUGDapagliflozin 10mg
Participants receive Dapagliflozin orally once a day
DRUGMetformin ≥ 1000mg
Metformin are administered at the same dose and formulation.
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Type II diabetes mellitus aged 19 years or older * Subjects who performed Dual therapies (complex allowed) for one of the following, along with meals and exercise therapy 1. Subjects who are receiving metformin ≥ 1000 mg/d and dapagliflozin 10 mg/d at the same dose for at least 8 weeks prior to the screening visit 2. Subjects who are receiving metformin ≥ 1000 mg/d and SGLT-2 inhibitor except for dapagliflozin at the same dose for at least 8 weeks prior to the screening visit * Subjects with 7.0%≤HbA1c≤10.5% at screening visit * Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit * Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening visit
Exclusion criteria
* Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic ketoacidosis, diabetic coma, pre-coma, lactic acidosis, and acute or chronic metabolic acidosis * patients with Hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia * Patients with severe infectious disease or severe traumatic systemic disorders * End stage renal disease or dialysis patients * Patients with Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption * Subjects with Liver cirrhosis, chronic active hepatitis B or C, cholecystitis, acromegaly, asthma or major skin allergies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c (%) After 24 weeks | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in FPG(mg/dL) After 24 weeks | 24 weeks |
| Change from baseline in HbA1c response rate(<7.0% ,<6.5%) After 24 weeks | 24 weeks |
| Change from baseline in 7-point SMBG After 24 weeks | 24 weeks |
Countries
South Korea
Outcome results
None listed