EUCTR2014-002685-70-SE进行中（未招募）1 期
The Effect of Sitagliptin on Glucagon Dynamics and Incretin Hormones During Mild Hypoglycemia in Elderly Patients with Metformin-Treated Type 2 Diabetes - SITACLAMP
und University0 个研究点开始时间: 2014年8月18日最近更新:
适应症
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
- •1. Written consent has been given.
- •2. Patients with metformin treated T2DM (metformin dose >=0.5/day and stable during the preceeding 3 months)
- •3. Age >=65 years.
- •4. HbA1c 6.0-8.5% (43-67 mmol/mol; inclusive) at visit 1.
- •5. Ability to complete the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1.Use of other glucose-lowering therapy than metformin within three months prior to visit 1.
- •2.A history of any secondary forms of diabetes, e.g., Cushing’s syndrome and acromegaly.
- •3.Type 2 diabetes, positive GAD antibodies
- •4.eGFR <60 ml/min
- •5.Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
- •6.Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.
- •7.Any history of acute pancreatitis
- •8.Any history of anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
- •9.Liver disease such as cirrhosis or chronic active hepatitis
- •10.History of coronary heart disease or heart failure class III or IV
- •11.Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
- •12.Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
- •13.Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
- •14.Hypersensitivity to sitagliptin or any compound in the tablet core (microcrystalline cellulose (E460), calcium hydrogen phosphate, anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b) or sodium stearyl fumarate) or in the film coating (poly(vinyl alcohol), macrogol (E3350), talc (E553b), titanium dioxide (E171), red iron oxide (E172) or yellow iron oxide (E172))
研究者
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