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

Launched by KOREA UNIVERSITY ANAM HOSPITAL · Oct 26, 2016

Keywords

ClinConnect Summary

ADA/EASD guideline recommends sequential treatment approach starting with metformin, and adding other classes of anti-diabetic medications if target HbA1c is not achieved. However, several clinical studies clearly showed that initial dual or triple combination therapy was more favorable in terms of glycemic control.

A DPP-4 inhibitor saxagliptin increases serum level of GLP-1, and potentiates its action of increasing glucose-dependent insulin secretion and lowering glucagon secretion. A SGLT-2 inhibitor dapagliflozin lowers hyperglycemia via blocking SGLT-2 to increase glucosuria, that is,...

Gender

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Eligibility 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