NCT05160272已完成2 期
Effects of GABAA Receptor Modulation by AP-325 on Insulin
The Deutsche Diabetes Forschungsgesellschaft e.V.1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2022年1月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Circulating C-peptide by iAUC of C-peptide during an IVGTT
研究概览
简要总结
The aim of this single-center, prospective, randomized, double-blind, placebo-controlled, 2-arm parallel-group interventional study is to investigate the effect of 4-week treatment with AP-325 on C-peptide release as measure of insulin secretion compared to placebo in type 2 diabetes (T2D) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of T2D
- •Age between 25 and 75 years
- •HbA1c ≥6.5 and ≤9.5 %
- •BMI ≤ 45 kg/m2
- •Treatment-naive or stable antihyperglycemic therapy with metformin, α-glucosidase-inhibitor and/or SGLT2 inhibitor
- •Ability to give consent
排除标准
- •Acute infections (hsCRP > 5mg/dl, body temperature >37.5°C)
- •Insulin therapy or treatment with sulfonylureas, glinides, GLP-1 receptor agonists, thiazolidinediones; current treatment with DPP-4 inhibitors or during the 4 weeks prior to baseline examination
- •Uncontrolled hyperglycemia, e.g. fasting blood glucose >240 mg/dl
- •Heart rate <50 or >100 beats per minute; systolic blood pressure <100 or >160 mmHg; diastolic blood pressure <50 or >100 mmHg; uncontrolled hypertension
- •Creatinine clearance <60 ml/min (eGFR by MDRD formula)
- •Severe chronic illnesses, such as congestive heart failure (NYHA III/IV), liver insufficiency (Child-Pugh Class B/C), history of acute coronary syndrome, stroke
- •Anemia (Hb <12 g/l for men, Hb <11 g/l for women)
- •Participation in another intervention study within 2 months before the examination
- •Hypersensitivity against AP-325, placebo or other ingredients of IMP
- •Immunocompromising diseases
- •Immunomodulatory drugs (e.g. oral cortisone preparations, biologicals)
- •Thyroid diseases with an unstable metabolic state (change in L-thyroxine dose within the past 6 weeks, TSH and fT4 outside the normal range)
- •Planned pregnancy, pregnant or lactating women, positive pregnancy test, and woman of childbearing potential not using two adequate methods of contraception, including a barrier method and a highly efficacious non-barrier method
- •Past (≤ 5 years) or current history of psychiatric disorders, including psychiatric depression
- •HIV, hepatitis B or C disease
- •Previous / current alcohol and / or drug abuse
- •Malignant cancer
- •BIA and MR-incompatible metal or magnetic implants, devices or objects inside of or on the body, claustrophobia
- •Treatment with the following drug groups or agents:
- •Anticoagulant drugs (exception: acetylsalicylic acid 100 mg/day), dihydropyridines (e.g. nifedipine, amlodipine), azilsartan, losartan and irbesartan, celecoxib; if applicable, other drugs that are predominantly metabolized by CYP2C9
- •Inhibitors or inducers of CYP2C9, CYP3A4, such as amiodarone, verapamil, rifampicin
- •Poor CYP2C9 metabolizer
研究组 & 干预措施
AP-325 Treatment
Experimental
AP-325, film-coated tablet, 50mg once daily
干预措施: AP-325 (Drug)
Placebo Treatment
Placebo Comparator
Placebo matching AP-325 film-coated tablet, once daily
干预措施: Placebo matching AP-325 (Drug)
结局指标
主要结局
Circulating C-peptide by iAUC of C-peptide during an IVGTT
时间窗: 4 weeks
Change in circulating C-peptide levels from baseline to end of intervention measured by iAUC of C-peptide during an IVGTT until 60th minute (second phase) with AP-325 compared to placebo
次要结局
- iAUC of circulating insulin (AIR) (first 10 min)(4 weeks)
- iAUC of C-peptide level (overall)(4 weeks)
- disposition index (DI)(4 weeks)
- Ctrough-ss (Day 28) and the change from baseline to Day 28(4 weeks)
- fructosamine levels III(4 weeks)
- Plasma concentrations of AP-325(4 weeks)
- Basal insulin level(4 weeks)
- C-peptide level(4 weeks)
- Glucose level(4 weeks)
- iAUC of glucose level (overall)(4 weeks)
- fructosamine levels(4 weeks)
- iAUC of circulating insulin (overall)(4 weeks)
- iAUC of C-peptide (first 10 min)(4 weeks)
- iAUC of glucose (first 10 min)(4 weeks)
- insulin secretion rate (ISR)(4 weeks)
- fructosamine levels II(4 weeks)
- peak insulin response(4 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil ArmParkinson DiseaseNCT03440112Nicolaas Bohnen, MD, PhD34
已完成
4 期
Brain GABA Levels and Treatment Response in Major Depressive DisorderMajor Depressive DisorderNCT00464711Massachusetts General Hospital40
已完成
1 期
Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil ArmParkinson DiseaseNCT03462641University of Michigan36
已完成
不适用
Intervention With a GABA Supplement in PrediabeticsHypertensionPrediabetesNCT04303468Wageningen University52
招募中
不适用
evels of GABA in the brain and treatment response in patients with schizophrenia - a cross-sectional multi-modal MRI studySchizophreniaJPRN-UMIN000030081Keio University School of Medicine Department of Neuropsychiatry75