EUCTR2017-000841-28-NL进行中（未招募）1 期
Combined effects of SGLT2 inhibition and GLP-1 receptor agonism on food intake, body weight and central satiety and reward circuits in obese T2DM patients - DECREASE, Dapagliflozine plus Exenatide and Central REgulation of Appetite in diabeteS typE 2
VU University Medical Center0 个研究点开始时间: 2017年8月14日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •- Age 18-65 years
- •- BMI 30–40 kg/m2
- •- Stable bodyweight (<5% reported change during the previous 3 months).
- •- Diagnosed with T2DM > 3 months prior to screening
- •- HbA1C 7.5–10%
- •- Treatment with metformin and/or sulphonylurea at a stable dose for at least 3 months.
- •- Right handed
- •- Both genders; for women: post menopausal (excluding possible menstruation cycle effects)
- •- Caucasian
- •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 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •- GLP-1 based therapies, DPP-4 inhibitors, thiazolidinediones or insulin within 3 months before screening
- •- Weight-lowering agents within 3 months before screening.
- •- Congestive heart failure (NYHA II-IV)
- •- Chronic renal failure (glomerular filtration rate < 60 mL/min/1.73m2 per Modification of Diet in Renal Disease (MDRD))
- •- Liver disease
- •- History of gastrointestinal disorders (including gastroparese, pancreatitis and cholelithiasis)
- •- Patients with MEN2 syndrome or history or family history of medullary thyroid carcinoma
- •- Neurological illness
- •- Malignancy (except for basal cell carcinoma)
- •- History of major heart disease
- •- History of major renal disease
- •- Pregnancy or breast feeding
- •- Implantable devices
- •- Substance abuse
- •- Addiction
- •- Alcohol abuse (defined as: for men > 21 units/week, for women >14 units/week)
- •- Smoking/ nicotine abuse (defined as: daily smoking / a daily use of nicotine)
- •- Contra-indication for MRI, such as claustrophobia or pacemaker
- •- Any psychiatric illness; including eating disorders and depression
- •- Chronic use of centrally acting agents or glucocorticoids within 2 weeks immediately prior to screening.
- •- Use of cytostatic or immune modulatory agents
- •- History of allergy for exenatide or other GLP-1 RA
- •- Participation in other studies at time of the screening visit
- •- Individuals who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
研究者
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