EUCTR2008-007335-40-CZ进行中（未招募）不适用
A randomized, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week double-blind treatment period assessing the efficacy and safety of lixisenatide in patients with Type 2 diabetes insufficiently controlled with insulin glargine and metformin - GETGOAL DUO 1
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
- 950
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
- •Patients meeting all of the following inclusion criteria will be screened:
- •I 01. Patients with type 2 diabetes mellitus, as defined by WHO, diagnosed for at least 1 year at the time of screening visit, insufficiently controlled with metformin at a stable dose of at least 1.5 g/day for at least 3 months prior to the screening visit. In addition to metformin, patients may receive sulfonylureas or glinides (both must be discontinued at the run-in visit (V2, week-12)) and/or thiazolidinediones (that can be continued).
- •I 02. Written informed consent obtained
- •At the end of the screening period (screening phase + run-in phase), patients with insufficient glycemic control (see E 27 and E 28) will enter the double-blind randomized treatment period
- •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
- •E 01. At screening age < legal age of majority
- •E 02. At screening: HbA1c < 7.0 or HbA1c >10%
- •E 03. Pregnancy or lactation
- •E 04. Women of childbearing potential with no effective contraceptive method.
- •Women of childbearing potential must have a confirmed negative serum pregnancy test at screening visit. They must use an effective contraceptive method throughout the study, and agree to repeat pregnancy tests at designated visits. The applied methods of contraception have to meet the criteria for a highly effective method of birth control according to the Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals”
- •E 05. Type 1 diabetes mellitus
- •E 06. Metformin not at a stable dose of at least 1.5 g/day for at least 3 months prior to the screening visit.
- •E 07. Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin, sulfonylurea, glinides and thiazolidinediones (e.g., alpha glucosidase inhibitor, other GPL-1 receptor agonists, DPP-IV inhibitors, insulin etc.) within 3 months prior to the time of screening
- •E 08. History of hypoglycemia unawareness.
- •E 09. Body Mass Index (BMI) =20 kg/m²
- •E 10. History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g multiple endocrine neoplasia syndromes),
- •E 11. History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
- •E 12. Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to the time of screening
- •E 13. Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization
- •E 14. Known history of drug or alcohol abuse within 6 months prior to the time of screening
- •E 15. Any clinically significant abnormality identified on physical examination, laboratory tests, ECG or vital signs at the time of screening that in the judgment of the investigator or any sub investigator would preclude safe completion of the study or constrains efficacy assessment such as active malignant tumor or other major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require laser treatment within the study period.
- •E 16. Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure > 180 mmHg or > 110 mmHg, respectively
- •E 17. Laboratory findings at the time of screening:
- •Amylase and/or lipase > 3 times the upper limit of the normal laboratory range
- •ALT > 3 ULN
- •Total bilirubin: > 1.5 times the upper limit of the normal laboratory range (except in
- •case of Gilbert’s syndrome)
- •Hemoglobin < 11 g/dL and/or neutrophils < 1,500/mm3 and/or platelets < 100,000/mm3
- •Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody
- •Positive serum pregnancy test in females of childbearing potential
- •Calcitonin = 20 pg/mL (5.9 pmol/L)
- •E 19. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening
- •E 20. Use of any investigational drug within 3 months prior to screening
- •E 21. Renal impairment defined with serum creatinine > 1.4 mg/dL in women and > 1.5 mg/dL in men
- •E 22. History of hypersensitivity to insulin g
研究者
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