Overview

Effectiveness & Tolerability of Novel, Initial Triple Combination Therapy vs Conventional Therapy in Type 2 Diabetes

Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
All
Summary
In this study, the investigators will assess the efficacy and tolerability of a novel, initial triple combination therapy with metformin, saxaglipitin, and dapagliflozin, compared to conventional stepwise add-on therapy in drug-naïve patients with recently onset type 2 diabetes.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Korea University Anam Hospital
Collaborator:
AstraZeneca
Treatments:
Dapagliflozin
Glimepiride
Metformin
Saxagliptin
Sitagliptin Phosphate
Criteria
Inclusion Criteria:

- Drug-naïve patients with type 2 diabetes by American Diabetes Association criteria

- HbA1c ≥ 8%, < 10.5% at screening

- Age ≥ 18 years, < 65 years

- Body mass index (BMI) ≥ 23 kg/m2, < 35 kg/m2

- Estimated GFR (eGFR) ≥ 60 ml/min/1.73m2

Exclusion Criteria:

- Uncontrolled hyperglycemia > 270 mg/dl after an overnight fast

- Diabetic ketoacidosis

- Type 1 diabetes

- Confirmed cardiovascular disease (acute coronary syndrome, stroke, or transient
ischemic attack) within 3 months of screening

- Congestive heart failure (New York Heart Association functional class IV)

- severe hepatic dysfunction (serum levels of either AST, ALT, or alkaline phosphatase
above 3 x upper limit of normal (ULN))

- alcohol abuse within the 3 months prior to informed consent that would interfere with
trial participation or any ongoing condition leading to a decreased compliance to
study procedures or study drug intake

- pregnant women, women with potential of pregnancy not using adequate contraception
method as evaluated by the investigator, lactating women

- use of systemic glucocorticoid