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Clinical Trial Details

Trial ID: L3973
Source ID: NCT03666546
Associated Drug: Lactulose Crystals 20 G
Title: Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Lactulose crystals 20 g|DRUG: Lactulose crystals 30 g|DRUG: Lactulose liquid 20 g|DRUG: Lactulose liquid 30 g|DRUG: Glucose|DRUG: Still water
Outcome Measures: Primary: Capillary blood glucose levels as baseline corrected AUC: AUCbaseline_c (0-180 minutes) [Baseline corrected area under curve from 0 to 180 minutes for blood glucose concentration (= Area under curve from 0 to 180 minutes minus baseline*180 minutes)], 0 - 180 minutes, during 4 study visits | Secondary: Maximum blood glucose concentration (Cmax), 0 - 180 minutes, during 4 study visits|Maximum increase of blood glucose concentration (Max_increase), 0 - 180 minutes, during 4 study visits|Relative maximum increase of blood glucose concentration (Max_increase_rel), 0 - 180 minutes, during 4 study visits|Time to reach maximum blood glucose concentration (Tmax), 0 - 180 minutes, during 4 study visits|Total area under curve from 0 to 180 minutes for blood glucose concentration (AUC(0-180 minutes)), 0 - 180 minutes, during 4 study visits|Incremental area under curve from 0 to 180 minutes for blood glucose concentration, i.e., above baseline levels for blood glucose concentration after oral intake of Laevolac crystals/liquid or control products (iAUC(0-180min)), 0 - 180 minutes, during 4 study visits | Other: Adverse Events (AEs), Adverse Events will be documented from start of fasting on the day before Screening until the day after the last study Intervention. This is up to 64 days, depending on the day of Screening (21 to 3 days before the first study Intervention) and on the duration of wash out phases between interventions., up to 64 days|Gastrointestinal tolerability: global scaled evaluation, Gastrointestinal tolerability will be assessed by the patients by means of a global scaled evaluation with "Very good", "Good", "Moderate", or "Poor"., 180 minutes and 24 hours post-dose|Gastrointestinal tolerability: diarrhoea, distension, rumbling, nausea, vomiting, burping, regurgitation/heartburn, flatulence, abdominal discomfort, abdominal pain, The single gastrointestinal symptoms will be assessed by the patients using a 4-point Likert scale: "No symptoms or discomfort", "Mild symptoms or discomfort", "Moderate symptoms of discomfort", or "Severe symptoms of discomfort"., 180 minutes and 24 hours post-dose|Blood glucose concentration at 240 minutes - only when blood glucose is >10 mmol/L (>180 mg/dL) at 180 minutes, 240 minutes post-dose
Sponsor/Collaborators: Sponsor: Fresenius Kabi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2018-11-26
Completion Date: 2019-03-08
Results First Posted:
Last Update Posted: 2019-04-12
Locations: Clinical Research Center (CRC), Graz, A-8036, Austria
URL: https://clinicaltrials.gov/show/NCT03666546