EUCTR2018-002359-14-AT进行中（未招募）1 期
Blood Glucose Response After Oral Intake of Lactulose (Laevolac®) in Mildly Constipated Patients with Diabetes Mellitus Type 2
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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
入选标准
- •1. Patients with non-insulin requiring diabetes mellitus type 2 treated with diet and oral
- •antidiabetics and/or GLP-1 receptor agonists
- •2. Age: 18-75 years
- •3. Female and male
- •4. Caucasian
- •5. HbA1c =7.5 %
- •6. Stable treatment, i.e. no change in diabetes mellitus related medication within the last
- •7. Mild functional constipation according to modified Rome IV criteria fulfilled for the
- •last 3 months with symptom onset at least 6 months before study start defined as:
- •a. approx. 3-5 bowel movements per week,
- •b. of which 1-2 usually cause discomfort e.g., straining, lumpy or hard stools,
- •sensation of incomplete evacuation or anorectal obstructions/blockage
- •8. Availability and presence in the trial unit for approx. 4 hours/ week for 4 weeks
- •9. Women of childbearing potential must be using a medically approved method of
- •contraception OR women must be postmenopausal for at least 12 months prior to
- •study entry
- •10. Signed Informed Consent form
- •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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1. Fasting blood glucose <4.4 mmol/L (<80 mg/dl) or >10 mmol/L (>180 mg/dL)
- •(capillary)
- •2. BMI <18.5 kg/m² or =35 kg/m²
- •3. Change in body weight =10 % within the last 3 months prior to randomization
- •5. Major medical or surgical event requiring hospitalization within the last 3 months
- •prior to randomization
- •6. Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2
- •weeks prior to randomization
- •7. Presence of disease or intake of drug(s)/ supplements other than antidiabetic treatment
- •influencing digestion and absorption of carbohydrates or bowel habits (intake of
- •laxatives in general allowed with exception see next criterion) (dietary/ supplementary
- •fibres allowed if stable dose since 1 month before study start)
- •8. Not willing to abstain from laxatives 2 days before the visits 1-4 and up to 24h after
- •visits 1-4;
- •9. Use of following medication/supplementation within the last 4 weeks and during the
- •a. Intake of medications other than antidiabetic treatment known to affect
- •glucose tolerance e.g., steroids, protease inhibitors or antipsychotics;
- •b. Intake of prebiotics or probiotics
- •c. Chronic intake of substances affecting blood coagulation (e.g. acetylsalicylic
- •acid (100 mg as standard prophylactic treatment allowed when dose is stable 1
- •month prior to screening), anticoagulants, diuretics, thiazides (diuretics and
- •thiazides allowed e.g. for hypertension treatment when dose is stable 1 month
- •prior to screening)), which in the investigator’s opinion would impact patient
- •10. Severe liver, renal or cardiac disease
- •11. Hereditary problems of galactose or fructose intolerance, lactase deficiency or
- •glucose-galactose malabsorption
- •12. Suspicion of alcohol abuse (defined as an average daily intake of more than one litre
- •of beer per day or equivalent amount of alcohol in other beverages) or drug abuse
- •13. Known or suspected allergy to the investigational drug(s) or other components of the
- •study drug(s)
- •14. Acute inflammatory bowel disease (ulcerative colitis, Crohn's disease),
- •gastrointestinal obstruction or subocclusive syndrome, perforations or risk of
- •perforation in gastrointestinal tract, abdominal pain of undetermined cause
- •15. Known history of human immunodeficiency virus (HIV), hepatitis B and/or C
- •16. Pregnancy, lactation
- •17. Clinically relevant findings as established by medical history, physical examination,
- •clinical laboratory (see section 14.3.2 Laboratory Variables) and/or vital sign
- •(Screening failure)
- •18. Participation in another interventional study with an investigational drug or an
- •investigational medical device within 30 days prior to start of study or during the
研究者
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