Blutzuckerreaktion nach der oralen Einnahme von Laktulose (Laevolac®) bei leicht verstopften Patienten mit Typ 2 Diabetes mellitus

Phase 1

• Conditions: Symptomatic treatment of constipation; MedDRA version: 20.0 Level: PT Classification code 10010774 Term: Constipation System Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-002359-14-AT
• Lead Sponsor: Fresenius Kabi Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

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
3 months
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

Exclusion Criteria

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
4. Smoker
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
study:
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
safety
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
study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified