EUCTR2011-004158-24-SK进行中（未招募）1 期
A 24-week, randomized, double-blind, active-controlled, parallel group trial to assess the superiority of oral linagliptin and metformin compared to linagliptin monotherapy in newly diagnosed, treatment naïve, uncontrolled Type 2 Diabetes Mellitus patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female patients, 18 years of age or older at Visit 1 (Screen), with newly diagnosed (less than 12 months prior to Screen) T2DM.
- •2. Patients who are treatment-naïve, defined as absence of any oral antidiabetic therapy, injectable GLP-1 agonist/analogue, or insulin, and uncontrolled for the 12 weeks prior to randomisation.
- •3. Patients must have an HbA1c between 8.5% [69 millimoles per mole (mmol/mol)] and 12.0% (108 mmol/mol) at Visit 1 (Screen).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 135
排除标准
- •1. Acute coronary syndrome (non-ST Elevation Myocardial Infarction (STEMI), STEMI, and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent.
- •2.Indication of liver disease determined during Screen and/or Run-In Period, defined by a serum level above 3 times the upper limit of normal (ULN) in any of the following: alanine aminotransferase [ALT or called serum glutamic pyruvic transaminase (SGPT)], aspartate aminotransferase [AST or serum glutamic oxaloacetic transaminase (SGOT)], or alkaline phosphatase. Gilbert-Meulengracht syndrome (also known as conjugated hyperbilirubinemia, constitutional hepatic dysfunction, or familial nonhemolytic jaundice) will be permitted.
- •3.Impaired renal function, defined as calculated creatinine clearance of less than 60 milliters per minute (< 60 mL/min), by the Cockcroft-Gault Equation, as determined during Screen and/or Run-In Period.
- •4.Bariatric, gastric bypass, and other gastrointestinal surgeries (including all types of gastric banding and/or LapBand?) within the past two years.
- •5.Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
- •6.Medical history of pancreatitis.
- •7.Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, haemolytic anaemia).
- •8.Any contraindication to metformin IR and/or linagliptin therapies, according to local labels.
- •9.Treatment with anti-obesity drugs, including over-the-counter drugs such as Alli?(orlistat), 3 months prior to informed consent or any other treatment at the time of screening (i.e., surgery, aggressive diet regimen, etc.) leading to unstable body weight.
- •10.Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM.
研究者
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