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Diabetes Mellitus, Type 2Phase 4NCT03666546

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

A Phase 4 study testing Lactulose crystals 20 g, Lactulose crystals 30 g and Lactulose liquid 20 g in people with Diabetes Mellitus, Type 2, run by Fresenius Kabi at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Lactulose crystals 20 g, Lactulose crystals 30 g and Lactulose liquid 20 g
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteAustria
Study dates
26 Nov 2018to 8 Mar 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Clinical Research Center (CRC)

    Graz, A-8036

Other trials in Austria

About this study

Official title: 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.

Being tested
Lactulose crystals 20 g, Lactulose crystals 30 g, Lactulose liquid 20 g, Lactulose liquid 30 g, Glucose
Keywords
Blood glucose, Diabetes Mellitus, Type 2, Lactulose, Constipation, Oral intake
Medical subject headings
Diabetes Mellitus, Type 2, Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lactulose crystals 20 gDrug

    Also called Laevolac crystals 20 g

    White or almost white crystalline powder. The product will be provided in sachets to be dissolved in 250 mL water.

  • Lactulose crystals 30 gDrug

    Also called Laevolac crystals 30 g

    White or almost white crystalline powder. The products will be provided in sachets to be dissolved in 250 mL water.

  • Lactulose liquid 20 gDrug

    Also called Laevolac liquid 20 g

    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.

  • Lactulose liquid 30 gDrug

    Also called Laevolac liquid 30 g

    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.

  • GlucoseDrug

    Also called Glucose Monohydrate

    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.

  • Still waterDrug

    Also called Water

    250 mL still water will be used. Water from the same source will be also used to dissolve investigational and control products

Study groups in NCT03666546
Study groupRoleWhat they receive
Laevolac crystals 20 gExperimentalLactulose crystals, oral intake, 20 g single dose
Receives: Drug: Lactulose crystals 20 g
Laevolac crystals 30 gExperimentalLactulose crystals, oral intake, 30 g single dose
Receives: Drug: Lactulose crystals 30 g
Laevolac liquid 20 gExperimentalLactulose liquid, oral intake, 20 g single dose
Receives: Drug: Lactulose liquid 20 g
Laevolac liquid 30 gExperimentalLactulose liquid, oral intake, 30 g single dose
Receives: Drug: Lactulose liquid 30 g
Glucose 30 gActive comparatorGlucose Monohydrate, oral intake, 33 g single dose
Receives: Drug: Glucose
WaterPlacebo comparatorStill water, oral intake, 250 mL single dose
Receives: Drug: Still water

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)]

    Measured: 0 - 180 minutes, during 4 study visits

Secondary outcomes (6)

  1. Maximum blood glucose concentration (Cmax)

    Measured: 0 - 180 minutes, during 4 study visits

  2. Maximum increase of blood glucose concentration (Max_increase)

    Measured: 0 - 180 minutes, during 4 study visits

  3. Relative maximum increase of blood glucose concentration (Max_increase_rel)

    Measured: 0 - 180 minutes, during 4 study visits

  4. Time to reach maximum blood glucose concentration (Tmax)

    Measured: 0 - 180 minutes, during 4 study visits

  5. Total area under curve from 0 to 180 minutes for blood glucose concentration (AUC(0-180 minutes))

    Measured: 0 - 180 minutes, during 4 study visits

  6. 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))

    Measured: 0 - 180 minutes, during 4 study visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study start26 Nov 2018
  3. Primary completion5 Mar 2019
  4. Study completion8 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03666546
Sponsor's protocol ID
Lact-004-CP4
Other IDs
2018-002359-14, 2018
Status last verified
Apr 2019
First submitted
23 Aug 2018
Last updated
12 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lactulose crystals 20 g, Lactulose crystals 30 g and Lactulose liquid 20 g in people with Diabetes Mellitus, Type 2, run by Fresenius Kabi at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03666546.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.

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