EUCTR2010-020684-20-SK进行中（未招募）不适用
A 24-week, multi-center, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of vildagliptin 50mg bid as an add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 428
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. Confirmed diagnosis of T2DM by standard criteria.
- •2. Treatment with stable, once or twice daily doses (maximum dose of 1 unit/kg/day) of basal long-acting,
- •intermediate-acting insulin alone or in pre-mixed combination with rapid-acting or short-acting insulin for at
- •least 12 weeks prior to Visit 1. Stable is defined as ±10% of the Visit 1 dose during the previous 12 weeks.
- •3. Patients receiving metformin must be on a stable dose of metformin (at least 1500 mg daily or a maximally
- •tolerated dose) for at least 12 weeks prior to Visit 1.
- •4. HbA1c =7.5 to =11% at Visit 1
- •5. Age: =18 to =80 years old at Visit 1
- •6. BMI =22 to =40 kg/m2 at Visit 1.
- •7. Males or females
- •8. Females must be non-fertile or females of childbearing potential must use a medically approved birth control
- •method based on local regulations
- •9. Agreement to maintain a stable dose of insulin and metformin, if applicable, throughout the study.
- •10. Agreement to continue current diet and exercise regime throughout the duration of the study, unless otherwise
- •instructed by the investigator.
- •11. Ability to comply with all study requirements.
- •12. Written informed consent must be obtained before any assessment is performed.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. FPG =270 mg/dl (15 mmol/L) at Visit 1
- •2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception
- •and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
- •3. Use of any of the following medications as assessed at Visit 1:
- •a. rapid or short acting insulin except in pre-mixed formulations with intermediate or long-acting insulin; insulin
- •administration more frequently than twice-daily, or total insulin dose >1 unit/kg/day for the past 12 weeks
- •b. Use of weight control products including weight-loss medications
- •c. DPP-4 inhibitors, GLP-1 analogues/mimetics, Oral Anti-diabetic Agents (OADs) except metformin within the
- •previous 6 months
- •d. Chronic oral (>7 consecutive days), parenteral or intra-articular corticosteroid treatment within 8 weeks
- •e. Treatment with growth hormone within the previous 6 months
- •f. Treatment with any drug of known and frequent toxicity to a major organ, or that may interfere with the
- •interpretation of the efficacy and safety data during the study.
- •4. A history or evidence of any of the following:
- •a. Acute metabolic conditions such an ketoacidosis, lactic acidosis or hyperosmolar state (including coma) within
- •the past 6 months.
- •b. Current diagnosis of congestive heart failure (NYHA III or IV).
- •c. Myocardial infarction (MI) within the past 6 months
- •d. Coronary artery bypass surgery or percutaneous coronary intervention within the past 6 months
- •e. Stroke or transient ischemic attack (TIA) within the past 6 months
- •f. Unstable angina within the past 3 months
- •g. Sustained and clinically relevant ventricular arrhythmia
- •h. Active substance abuse including alcohol (> 3 drinks per day on average and/or binge drinking of more than 5
- •drinks in 1 day during the last 6 months) and alcohol related history of disease within the past 2 years.
- •i. Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- •(e.g. Cushing’s syndrome or acromegaly-associated diabetes).
- •j. Malignancy of an organ system (other than localized basal cell carcinoma of the skin) treated or untreated,
- •within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
- •k. Hepatic disorder defined as:
- •i. acute or chronic liver disease, evidence of hepatitis, cirrhosis or portal hypertension
- •ii. history of imaging abnormalities that suggest liver disease (except hepatic steatosis), such as portal
- •hypertension, capsule scalloping, cirrhosis
- •l. acute infections which may affect blood glucose conrtol within the past 4 weeks
- •5. Any of the following significant laboratory abnormalities as assessed at Visit 1:
- •a. Clinically significant TSH outside of the normal range
- •b. Clinically significant renal dysfunction as indicated by serum creatinine levels at Visit 1:
- •i. for patients receving metformin = 1.5 mg/dL (132 µmol/L) for males and = 1.4 mg/dL (123 µmol/L) for
- •ii. for other patients: abnormal creatinine clearance or evidence of renal impairment as determined by eGFR <30
- •ml/min/1.73m2 (MDRD)
- •c. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) at
- •Visit 1, confirmed by repeat measure within 3 working days
- •d. Total bilirubin > 2 xULN and/or direct bilirubin > 1 x ULN confirmed by repeat measure within 3 working
- •e. Positive Hepatitis B surface antigen (HbsAg)
- •f. Positive Hepatitis C antibody test (anti-HCV)
- •g. Elevated fasting tr
研究者
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