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Type 2 Diabetes MellitusPhase 1AREBAGNCT03510624

Acute Effect of Rebaudioside A on Glucose Excursion During an Oral Glucose Tolerance Test in Type 2 Diabetes Mellitus

A Phase 1 study testing Rebaudioside A in people with Type 2 Diabetes Mellitus, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

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

Investigate the acute effect of the steviol glycoside, rebaudioside A, on the glucose excursion during an oral glucose tolerance test in 30 patients with type 2 diabetes mellitus. Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Rebaudioside A
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteBelgium
Study dates
9 Nov 2018to 1 Apr 2021
Phase
Phase 1
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 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated written informed consent
  • Understand procedures
  • Type 2 diabetes mellitus
  • Body Mass Index (BMI): 25 - 40 kg/m2
  • HbA1c: 6.5-8%
  • Judged to be in good health

Who cannot join

  • Subject is unable to
  • Refrain from stevia leaves, stevia extracts or steviol glycoside-containing products from 5 days prior to administration of rebaudioside A or placebo until discharge from the unit after the OGTT on the consecutive day.
  • Refrain from quinine-containing products from 72h prior to administration of rebaudioside A or placebo until discharge from the unit after the OGTT on the consecutive day.
  • Maintain their habitual diets and physical activity patterns and refrain from engaging in strenuous physical activities from 72h prior to administration of rebaudioside A or placebo until discharge from the unit after the OGTT on the consecutive day.
  • Refrain from grapefruit products from 14 days before study visit 1 until discharge from the unit after the OGTT on study visit 4.
  • Refrain from alcohol from 24h prior to administration of rebaudioside A or placebo until discharge from the unit after the OGTT on the consecutive day.
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  • Refrain from caffeine containing products from 12h prior to administration of rebaudioside A or placebo until discharge from the unit after the OGTT on the consecutive day.
  • Fast at least 5 hours prior to the administration of rebaudioside A or placebo on study days 1 and 3.
  • Fast at least 10 hours prior to the study days 2 and 4.
  • Women of childbearing potential (last menstruation less than 1 year prior to screening) who are pregnant, lactating or planning to become pregnant during the study.
  • Individuals with other forms of diabetes
  • Current or previous treatment with any diabetes drug within 3 months prior to screening, except for metformin.
  • Symptomatic hyperglycemia requiring immediate therapy during screening, in the judgement of the principal investigator.
  • Evidence of significant diabetic complications.
  • History of pancreas or beta-cell transplantation.
  • Presence or history of clinically relevant medical, surgical or psychiatric conditions likely to affect the subject's safety in this trial or that could confound the study assessments or endpoints.
  • Clinically relevant abnormal physical findings.
  • Clinically significant abnormalities of vital signs:
  • Seated systolic blood pressure outside 90-160 mmHg
  • Diastolic blood pressure outside 40-100 mmHg
  • Heart rate <50 bpm
  • Corrected QT (QTC) using Fridericia's formulae >450 msec (for men) or >470 msec (for women) measured with a 12-lead electrocardiogram.
  • Clinically significant abnormal laboratory values.
  • Moderate or severe renal dysfunction defined as a calculated glomerular filtration rate (GFR) <30 ml/min.
  • Currently active or history of alcohol abuse.
  • Currently active or history of drug addiction or currently a regular user of drugs including "recreational use" of any illicit drug.
  • Smoking cigarettes or using nicotine-containing products, during the last 6 months prior to screening, as nicotine inhibits the Transient Receptor Potential 5 (TRPM5) channel.
  • Individuals for whom a major surgery is planned to occur between screening and the end of the trial.
  • Previous or current use of concomitant medication, which would confound the study conduct or implicate a risk for safety of the participant, as judged by the investigator(s).
  • History of relevant drug or food allergies or a history of severe anaphylactic reaction.
  • History of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures.
  • Individuals with hepatitis B and/or hepatitis C virus.
  • Individuals with Human Immunodeficiency Virus (HIV).
  • Participation in another clinical trial involving an investigational product within the 3 months preceding screening or 5-halflives of the drug studied, whichever is longer, prior to study supplement administration. Or, participation in any other type of medical research within 3 months preceding screening judged not to be scientifically or medically compatible with this study.
  • Individuals who have donated or lost more than 500 ml blood or plasma within 3 months prior to screening.
  • Individuals unable to swallow orally administered medication.
  • Individuals in which catheter placement is impossible (amputation, no visible veins, …)
  • Individuals that cannot speak or understand the Dutch language.
  • In the opinion of the principal investigator any other factor that could interfere with the subject's ability to provide informed consent or to complete the study with strict compliance to the study protocol, or that could hold safety concerns for the subject or could impact the outcome of the study results.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Centrum Clinical Pharmacology

    Leuven, Flanders, 3000

Other trials in Belgium

About this study

Official title: Investigation of the Acute Effect of Rebaudioside A on the Glucose Excursion During an Oral Glucose Tolerance Test in 30 Patients With Type 2 Diabetes Mellitus (AREBAG)

Investigate the acute effect of the steviol glycoside, rebaudioside A, on the glucose excursion during an oral glucose tolerance test in 30 patients with type 2 diabetes mellitus.

Read the detailed description

Eligible individuals with type 2 diabetes mellitus will be invited for four study visits. During the first and third study visit, rebaudioside A or the placebo will be administered. During the second and fourth study visit, an oral glucose tolerance test (OGTT) will be executed to measure the response of administration of rebaudioside A versus placebo on the glucose homeostasis. The area under the curve blood glucose values during the first two hours of the OGTT will be compared for both conditions.

Being tested
Rebaudioside A, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Rebaudioside ADrug

    Rebaudioside A 3g

  • PlaceboDrug

    Empty capsules

Study groups in NCT03510624
Study groupRoleWhat they receive
First rebaudioside A and then placeboExperimentalNot described
Receives: Drug: Rebaudioside A; Drug: Placebo
First placebo and then rebaudioside AExperimentalNot described
Receives: Drug: Rebaudioside A; Drug: Placebo

What is being measured

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

  1. Area under the curve (AUC) blood glucose concentrations during an OGTT

    Area under the curve blood glucose concentrations during an OGTT

    Measured: 0 to 2 hours after glucose challenge

Secondary outcomes (8)

  1. AUC glucose/insulin/glucagon

    AUC glucose/insulin/glucagon

    Measured: -30 to 0 min of OGTT

  2. AUC glucose/insulin/glucagon

    AUC glucose/insulin/glucagon

    Measured: 0 to 30 min of OGTT

  3. AUC glucose/insulin/glucagon

    AUC glucose/insulin/glucagon

    Measured: 0 to 4 hours of OGTT

  4. Maximal blood glucose

    Maximal blood glucose

    Measured: -30 min to 4 hours of OGTT

  5. Maximal blood glucose excursion

    Maximal blood glucose excursion

    Measured: -30 min to 4 hours of OGTT

  6. Maximal serum insulin

    Maximal serum insulin

    Measured: -30 min to 4 hours of OGTT

  7. Maximal serum glucagon

    Maximal serum glucagon

    Measured: -30 min to 4 hours of OGTT

  8. Concentration(t) (C(t))rebaudioside A, steviol and steviol glucuronide

    Concentration of rebaudioside A, steviol and steviol glucuronide on different time points

    Measured: -30 min to 4 hours of OGTT

Timeline

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

  1. First posted27 Apr 2018
  2. Study start9 Nov 2018
  3. Primary completion1 Apr 2021
  4. Study completion1 Apr 2021

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03510624
Sponsor's protocol ID
s61580
Acronym
AREBAG
Status last verified
Apr 2021
First submitted
17 Apr 2018
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Simoens C, Philippaert K, Wuyts C, Goscinny S, Van Hoeck E, Van Loco J, Billen J, de Hoon J, Ampe E, Vangoitsenhoven R, Mertens A, Vennekens R, Van der Schueren B. Pharmacokinetics of Oral Rebaudioside A in Patients with Type 2 Diabetes Mellitus and Its Effects on Glucose Homeostasis: A Placebo-Controlled Crossover Trial. Eur J Drug Metab Pharmacokinet. 2022 Nov;47(6):827-839. doi: 10.1007/s13318-022-00792-7. Epub 2022 Sep 3.

    PubMed 36057030

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rebaudioside A in people with Type 2 Diabetes Mellitus, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

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 6 inclusion and 39 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 28 Apr 2021. 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 Belgium. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Area under the curve (AUC) blood glucose concentrations during an OGTT (time frame: 0 to 2 hours after glucose challenge). 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 NCT03510624, which also lists 1 linked publication.

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 28 Apr 2021.

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