CTRI/2009/091/000807已完成3 期
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. - GET GOAL DUO 1
SanofiSynthelabo India Limited0 个研究点目标入组 450 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients with type 2 diabetes mellitus, as defined by WHO (1), 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 (that must be discontinued at visit 1) and/or
- •thiazolidinediones (that can be continued).
排除标准
- •At screening:
- •- Pregnancy or lactation
- •- Women of childbearing potential with no effective contraceptive method.
- •- Type 1 diabetes mellitus
- •- Metformin not at a stable dose of at least 1.5 g/day for at least 3 months prior to the screening visit.
- •- Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin, sulfonylurea and thiazolidinediones within 3 months prior to the time of screening, use of weight loss drugs if not at a stable dose for at least 3 months prior to the screening visit.
- •- History of hypoglycemia unawareness.
- •- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
- •- History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
- •- Hemoglobinopathy or hemolytic anemia, blood or plasma products transfusion within 3 months prior to the time of screening
- •- Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization
- •- Known history of drug or alcohol abuse within 6 months prior to the time of screening
- •- Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure > 180 mmHg or > 110 mmHg, respectively
- •- Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening
- •- Use of any investigational drug within 3 months prior to screening
- •- Renal impairment defined with serum creatinine > 1.4 mg/dL in women and > 1.5 mg/dL in men
- •- History of hypersensitivity to insulin glargine or to any of the excipients
- •- Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e worsening) and not controlled (i.e prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening
- •- Any previous treatment with lixisenatide (e.g. participation in a previous study with lixisenatide)
- •- Allergic reaction to any GLP-1 receptor agonist in the past (e.g. exenatide, liraglutide) or to metacresol.
- •Additional exclusion criteria during or at the end of the run-in phase before randomization :
- •- Informed consent withdrawal (patient who is not willing to continue or fails to return)
- •- Mean fasting SMPG calculated from the self-measurements for the 7 days prior to visit 12 (week -1) is > 126 mg/dl (7.0 mmol/l)
- •- HbA1c measured at visit 12 (week -1) is < 7% or > 9 %,
- •- Amylase and/or lipase > 3 times the upper limit of the normal laboratory range at visit 12 (week -1)
研究者
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