NL-OMON40321撤回4 期
Effects of GLP1 agonist liraglutide in patients with antipsychotic-drugs-associated diabetes mellitus - GRADUATE
Interne geneeskunde0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 50
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Severe mental disorder (schizophrenia and schizophrenia-related; these disorders are defined with one of the following DSM-codes: 295.10, 295.20, 295.30, 295.40, 295.60, 295.70, 295.90, 297.1, 297.3, 298.8, 298.9)
- •* Informed consent obtained before any trial related activities
- •* Males or females aged 18 years or older
- •* Diabetes mellitus developed while on anti-psychotic drugs, Diabetes Mellitus for at least six months
- •* Use of metformin for the treatment of diabetes for at least three months
- •* HbA1c >7.0% - * 10.0 mmol/l (53 * 69 mmol/mol)
- •* BMI 30 * 45 kg/m2
- •* Regarded capable to understand and follow the protocol
排除标准
- •Any type of diabetes present prior to the use of anti-psychotic drugs (including type 1 diabetes)
- •* Use of glucose-lowering medication other than metformin, current use of within 3 months prior to start of the study
- •* Any cardiovascular event in the last 6 months
- •* Reduced cardiac function (LVEF < 30%)
- •* Any evidence of active retinopathy
- •* Uncontrolled hypertension (systolic pressure > 180 mm Hg and/or diastolic pressure > 100 mm Hg
- •* Compromised renal function (MDRD < 60 ml/min)
- •* Liver function abnormalities (ALT and/or AST > 3 times the upper limit of normal)
- •* History of chronic pancreatitis or previous acute pancreatitis
- •* Known or suspected hypersensitivity to trial product(s) or related product(s)
- •* Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant or is not using adequate contraceptive methods
- •* Participation in another trial or receipt of any investigational medicinal product within 90 days prior to screening
- •* Subjects who are considered incapable for inclusion by their physicians
- •* Subjects who are considered inadequate for liraglutide administration themselves and lack network of support
- •* Subjects who are actively suicidal
- •* Recurrent use of corticosteroids
- •* Personal or family history of medullary thyroid carcinoma and patients with multiple endocrine neoplasia type 2 (MEN2)
- •* Known or suspected abuse of alcohol or narcotics during the trial
研究者
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