Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2

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
• •4. Smoker
• •5. Major medical or surgical event requiring hospitalization within the last 3 months
• •6. Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
• •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:
• •* Intake of medications other than antidiabetic treatment known to affect glucose tolerance e.g., steroids, protease inhibitors or antipsychotics;
• •* Intake of prebiotics or probiotics
• •* Chronic intake of substances affecting blood coagulation (e.g. acetylic 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 and/or vital signs
• •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