- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03666546
Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2
April 11, 2019 updated by: Fresenius Kabi
Blood Glucose Response After Oral Intake of Lactulose (Laevolac®) in Mildly Constipated Patients With Diabetes Mellitus Type 2
The objective of the study is to investigate whether lactulose, given orally as powder or liquid, increases blood glucose levels in patients with diabetes mellitus type 2. The dose of lactulose given in the study is normally used for treatment of constipation.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Graz, Austria, A-8036
- Clinical Research Center (CRC)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with non-insulin requiring diabetes mellitus type 2 treated with diet and oral antidiabetics and/or Glucagon-like Peptide 1 receptor agonists
- Age: 18-75 years
- Female and male
- Caucasian
- HbA1c ≤ 7.5 %
- Stable treatment, i.e. no change in diabetes mellitus related medication within the last 3 months
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:
- approx. 3-5 bowel movements per week,
- of which 1-2 usually cause discomfort e.g., straining, lumpy or hard stools, sensation of incomplete evacuation or anorectal obstructions/blockage
- Availability and presence in the trial unit for approx. 4 hours/ week for 4 weeks
- 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
- Signed informed consent form
Exclusion Criteria:
- Fasting blood glucose <4.4 mmol/L (<80 mg/dL) or >10 mmol/L (>180 mg/dL) (capillary)
- BMI <18.5 kg/m² or ≥35 kg/m²
- Change in body weight ≥10 % within the last 3 months
- Smoker
- Major medical or surgical event requiring hospitalization within the last 3 months
- Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
- 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)
- Not willing to abstain from laxatives 2 days before the visits 1-4 and up to 24h after visits 1-4
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
- Severe liver, renal or cardiac disease
- Hereditary problems of galactose or fructose intolerance, lactase deficiency or glucose-galactose malabsorption
- 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
- Known or suspected allergy to the investigational drug(s) or other components of the study drug(s)
- 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
- Known history of human immunodeficiency virus (HIV), hepatitis B and/or C
- Pregnancy, lactation
- Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Laevolac crystals 20 g
Lactulose crystals, oral intake, 20 g single dose
|
White or almost white crystalline powder.
The product will be provided in sachets to be dissolved in 250 mL water.
Other Names:
|
Experimental: Laevolac crystals 30 g
Lactulose crystals, oral intake, 30 g single dose
|
White or almost white crystalline powder.
The products will be provided in sachets to be dissolved in 250 mL water.
Other Names:
|
Experimental: Laevolac liquid 20 g
Lactulose liquid, oral intake, 20 g single dose
|
Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution).
The products will be provided in sachets to be dissolved in 250 mL water.
Other Names:
|
Experimental: Laevolac liquid 30 g
Lactulose liquid, oral intake, 30 g single dose
|
Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution).
The products will be provided in sachets to be dissolved in 250 mL water.
Other Names:
|
Active Comparator: Glucose 30 g
Glucose Monohydrate, oral intake, 33 g single dose
|
White crystalline powder.
To standardise for 30 g glucose, 33 g glucose monohydrate will be used.
The products will be provided in sachets to be dissolved in 250 mL water.
Other Names:
|
Placebo Comparator: Water
Still water, oral intake, 250 mL single dose
|
250 mL still water will be used.
Water from the same source will be also used to dissolve investigational and control products
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)]
Time Frame: 0 - 180 minutes, during 4 study visits
|
0 - 180 minutes, during 4 study visits
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum blood glucose concentration (Cmax)
Time Frame: 0 - 180 minutes, during 4 study visits
|
0 - 180 minutes, during 4 study visits
|
Maximum increase of blood glucose concentration (Max_increase)
Time Frame: 0 - 180 minutes, during 4 study visits
|
0 - 180 minutes, during 4 study visits
|
Relative maximum increase of blood glucose concentration (Max_increase_rel)
Time Frame: 0 - 180 minutes, during 4 study visits
|
0 - 180 minutes, during 4 study visits
|
Time to reach maximum blood glucose concentration (Tmax)
Time Frame: 0 - 180 minutes, during 4 study visits
|
0 - 180 minutes, during 4 study visits
|
Total area under curve from 0 to 180 minutes for blood glucose concentration (AUC(0-180 minutes))
Time Frame: 0 - 180 minutes, during 4 study visits
|
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))
Time Frame: 0 - 180 minutes, during 4 study visits
|
0 - 180 minutes, during 4 study visits
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events (AEs)
Time Frame: up to 64 days
|
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
Time Frame: 180 minutes and 24 hours post-dose
|
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
Time Frame: 180 minutes and 24 hours post-dose
|
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
Time Frame: 240 minutes post-dose
|
240 minutes post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Pieber, Prof. MD, Head and Chair of Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University, Graz, Austria
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 26, 2018
Primary Completion (Actual)
March 5, 2019
Study Completion (Actual)
March 8, 2019
Study Registration Dates
First Submitted
August 23, 2018
First Submitted That Met QC Criteria
September 10, 2018
First Posted (Actual)
September 12, 2018
Study Record Updates
Last Update Posted (Actual)
April 12, 2019
Last Update Submitted That Met QC Criteria
April 11, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Gastrointestinal Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Lactulose
- Methamphetamine
Other Study ID Numbers
- Lact-004-CP4
- 2018-002359-14 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
HighTide Biopharma Pty LtdRecruitingT2DM (Type 2 Diabetes Mellitus)China
-
AstraZenecaNot yet recruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on Lactulose crystals 20 g
-
Fresenius KabiCompleted
-
Institute of Liver and Biliary Sciences, IndiaUnknown
-
William Beaumont HospitalsCompleted
-
ACO Hud Nordic ABThe University of Sheffield Medical SchoolCompletedDermatitis, AtopicUnited Kingdom
-
Oxford Brookes UniversityRoquette FreresCompletedHealthyUnited Kingdom
-
Maastricht University Medical CenterCompleted
-
Purdue UniversityCompleted
-
Sergio Montserrat de la PazSpanish National Research CouncilCompletedInflammation | Obesity | Metabolic Syndrome | Metabolic Disorder | Immune System and Related DisordersSpain
-
Jena University HospitalGerman Research Foundation; Instituto Grifols, S.A.; University Hospital Goettingen and other collaboratorsRecruiting
-
Purdue UniversityTate & Lyle Health & Nutrition SciencesCompletedOsteoporosis, Postmenopausal