A multicenter, randomized, open-label study to compare the effects of gemigliptin add-on or dose escalation of metformin on glycemic control and safety in patients with inadequately controlled type 2 diabetes mellitus on metformin and SGLT-2 inhibitors
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 65
研究概览
简要总结
Background. We aimed to compare efficacy and safety between gemigliptin add-on and escalation of the metformin dose in patients with inadequately controlled type 2 diabetes mellitus (T2DM) despite treatment with metformin and SGLT2 inhibitors. Methods. This study was a multicenter, randomized, open-label, active-controlled, parallel-group comparative study. Patients with T2DM uncontrolled on metformin and SGLT2 inhibitors were randomized to receive gemigliptin 50 mg as an add-on (GEM group, n = 37) or escalation of the metformin dose (500 mg, MET group, n = 38) for 24 weeks. The primary endpoint was the change in glycosylated hemoglobin (HbA1c) from baseline to week 24. Results. At weeks 12 and 24, the reduction in HbA1c levels was significantly greater in the GEM group than in the MET group (GEM vs. MET = -0 64% ± 0 34% vs. -0 36% ± 0 50%, p = 0 009 at week 12; -0 61% ± 0 35% vs. -0 33% ± 0 70%, p = 0 045 at week 24). The proportions of patients who achieved target HbA1c levels of <7.0% at weeks 12 and 24 and <6.5% at week 12 were greater in the GEM group than in the MET group. An index of ß-cell function was also significantly improved in the GEM group. The safety profiles were similar between the two groups. Conclusions. Gemigliptin add-on therapy may be more effective than metformin dose escalation in patients with T2DM insufficiently controlled using metformin and SGLT2 inhibitors, without safety concerns. This trial is registered with CRIS_number: KCT0003520.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1)Type 2 diabetic patients
- •2) 7% = HbA1c = 10%
- •3) Body mass index greater than 18.5 kg / m2 and less than 40 kg / m2
- •4) V1 (screening) Those who are taking metformin (not less than 1000mg per day and 2000mg per day) and SGLT2 inhibitors (dapagliflozin, ipragliflozin, empagliflozin)
- •5) A voluntary written consent to participate in this clinical trial.
排除标准
- •? GFR estimated to be less than 45 mL / min / 1.73 m 2
- •? Patients with hypersensitivity or intolerance to DPP4 inhibitors
- •? cardiovascular collapse, acute myocardial infarction and septicemia, which can be caused by conditions such as kidney disease or drug therapy is needed for patients with congestive heart failure
- •? Patients with acute or chronic metabolic acidosis, including type 1 diabetes, diabetic ketoacidosis with or without coma, and patients with a history of ketogenic acidosis
- •? Patient with a history of cardiovascular disease, myocardial infarction or PCI (stenting or ballooning) within 6 months
- •? V1 (screening) Patients who used other hypoglycemic agents other than metformin and SGLT2 inhibitor (DPP4 inhibitor, sulphonylurea, glinide, a-glucosidase inhibitor, thiazolidinedione, GLP-1 RA, insulin)
- •? patients with malnutrition, starvation, weakness, pituitary dysfunction or adrenal insufficiency
- •? liver dysfunction (AST or ALT is more than 3 times the normal upper limit),
- •? Patient with pulmonary dysfunction of menopausal color or severe
- •? Patients with history of alcohol or substance abuse during the previous 3 months
- •? Pregnant women or possibly pregnant women,
- •? When you take the following medications
- •All medicines, including generic medicines, should be consulted before taking any medicines.
- •The following drugs are prohibited in combination with V1 (screening) for 4 weeks before the clinical trial (until the last visit).
- •- diabetes drugs other than test drugs
- •- Glucocorticoids
- •- Anti-obesity drug
- •- Cyclosporin, sirolimus, tacrolimus
- •- Isotretinoin
- •- Chemotherapy for cancer
- •? Any other patient who is deemed inappropriate by the examiner as the subject of the clinical trial.