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

Korea University Anam Hospital104 enrolled

Overview

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.

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, in an insulin-independent manner. Therefore, the mechanism of action of these drugs are complimentary to that of metformin, and all of these have a low risk of hypoglycemia and weight gain.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Diabetes Mellitus, Type II

Interventions

triple combination therapyDRUG

Xigduo (metformin 1000mg + dapagliflozin 10mg) saxagliptin 5mg

Stepwise add-on therapyDRUG

metformin -\> glimepirde -\> sitagliptin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Korea University Anam Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Proportion of patients who met HbA1c < 6.5% without hypoglycaemia, weight gain, or discontinuation due to adverse events at 104 weeks

Time frame: 104 weeks

Secondary Outcomes

∙ Proportion of patients who met HbA1c < 6.5% without hypoglycaemia, weight gain, or discontinuation due to adverse events at 52 weeks

Time frame: 52 weeks

Proportion of patients who met HbA1c < 7.0% without hypoglycaemia, weight gain, or discontinuation due to adverse events at 104 weeks

Time frame: 104 weeks

Change in body HbA1c from baseline to week 104

Time frame: 104 weeks

Change in body weight from baseline to week 104

Time frame: 104 weeks

Change in systolic blood pressure from baseline to week 104

Time frame: 104 weeks

Changes in fat and lean mass from baseline to at 104 weeks

Time frame: 104 weeks

Central Contacts

SinGon Kim, MD

CONTACT

010-4191-0958 k50367@korea.ac.kr

Data from ClinicalTrials.gov

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