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