EUCTR2018-003557-21-DE进行中（未招募）1 期
Effect of insulin glargine and lixisenatide versus insulin glargine on brain insulin sensitivity in patients with type 2 diabetes
niversity Hospital Tuebingen0 个研究点目标入组 40 人开始时间: 2018年10月17日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •Subjects meeting all of the following criteria will be considered
- •for admission to the trial:
- •Must be between 18 and 65 years at the time of signing
- •the informed consent.
- •BMI 25-45 kg/m²
- •Understand and voluntarily sign an informed consent
- •document prior to any study related
- •assessments/procedures.
- •Ability to adhere to the study visit schedule and other
- •protocol requirements.
- •Patients with type 2 diabetes mellitus diagnosed for at
- •least 1 year before the screening visit (visit 1) treated for
- •at least 3 months prior to visit 1 with only metformin or
- •metformin and a sodium glucose co-transporter 2
- •inhibitor, and patients who are not adequately controlled
- •with this treatment.
- •Females of childbearing potential (FCBP) must agree
- •? to utilize a highly effective forms of contraception
- •(Pearl index < 1) or practice complete abstinence
- •from heterosexual contact while participating in
- •the study (including dose interruptions), and for
- •at least 28 days after study treatment
- •discontinuation and must agree to pregnancy
- •testing during this timeframe
- •? to abstain from breastfeeding during study
- •participation and 28 days after study drug
- •discontinuation.
- •Males must agree
- •? to use a latex condom during any sexual contact
- •with FCBP while participating in the study and for
- •28 days following discontinuation from this study,
- •even if he has undergone a successful vasectomy
- •? to refrain from donating semen or sperm while
- •participating in this study and for 28 days after
- •discontinuation from this study treatment.
- •All subjects must agree to refrain from donating blood
- •while on study drug and for 28 days after discontinuation
- •from this study treatment.
- •All subjects must agree not to share medication.
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects presenting with any of the following criteria will not be included in the trial:
- •HbA1c at screening visit less than 7.5% or more than 12% for patients previously treated with metformin alone or with metformin and a second oral anti-diabetic treatment.• Women during pregnancy and lactation.• History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal products. This includes iGlarLixi, insulin glargine, and human nasal insulin.
- •Use of oral glucose-lowering agents other than those stated in the inclusion criteria or any injectable glucoselowering
- •agents during 3 months before screening • History of discontinuation of a previous treatment with a GLP-1 receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy. • Patient who has previously participated in any clinical trial with lixisenatide or the insulin glargine +lixisenatide fixed ratio combination or has previously received lixisenatide.
- •Any contraindication to metformin use, according to local labeling. • Use of weight loss drugs within 3 months prior to screening visit. • Within the last 6 months prior to screening visit: myocardial infarction, unstable angina, or heart failure
- •requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be
- •performed during the study period. • History of stroke. • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery. • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes). • Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 160 mmHg or diastolic blood pressure above 90 mmHg) at screening visit. • At screening visit, Body Mass Index (BMI) less than or equal to 25 or above 45 kg/m². • At screening visit ALT or AST more than 3 ULN. • At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L). • Exclusion Criteria for randomization at the end of the screening period: o HbA1c less than 7.5% or above 12%. o Amylase and/or lipase more than 3 ULN. o Calcitonin above or equal to 20 pg/mL (5.9pmol/L). • Participation in other clinical trials or observation period of competing trials up to 30 days prior to this study. • Known malformation of the central nervous system• Persons working nightshift• Treatment with drugs with central nervous actions or systemic steroid therapy • Any relevant (according to investigator’s judgment) cardiovascular disease, e.g. myocardial infarction, acute coronary syndrome, unstable angina pectoris,PTCA, heart failure (NYHA II-IV), planned coronary,carotid or peripheral artery revascularisation procedures to be performed during the study period.
- •Indication of liver disease, as per medical history or defined by serum levels of either Alanine,Aminotransferase (ALT [SGPT]), Aspartate Aminotransferase (AST [SGOT]), or Alkaline Phosphatase above 3 x upper limit of normal (ULN) as determined during screening.• Alcohol abuse, defined as more than 20 gr/day • Impaired renal function, defined as estimated Glomerular Filtration Rate (eGFR) = 60 ml/min (MDRD formula) as determined duri
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