PrediabetesPhase 3NCT02541344
Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects
A Phase 3 study testing Dose 1 of IQP-VV-102 and Dose 2 of IQP-VV-102 in people with Prediabetes and Hyperglycemia, run by InQpharm Group at 1 site in Germany.
Trial summary
In this trial, the investigational product , the active ingredients which has been proven to reduce postprandial glucose in healthy and diabetic patients, will be tested. The primary aim of this clinical study is to evaluate the possibility of the investigational product to reduce the rise of postprandial glucose AUC… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Hyperglycemia
- What is being tested?
- Dose 1 of IQP-VV-102 and Dose 2 of IQP-VV-102
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Oct 2015
- Phase
- Phase 3
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian
- BMI between ≥ 25 and < 30 kg/m2
- Normal to prediabetic biomarkers: FBG 3.9-6.9 mmol/L / 70-125mg/dL and HbA1c 4-6.4%
- Willing to take test meal and adhere to consumptions of pre-prepared meals supplied (controlled by subject diary)
- Willing to maintain same level of physical activity during the study
- Willing to arrive at the study site with the same, non-strenuous means of transportation during the study
Show all 9Show fewer
- Negative pregnancy testing (beta hCG) for women of childbearing potential during screening
- Women of child-bearing potential have to agree to use appropriate birth control methods during the study period
- Written informed consent of the subject to participate is a prerequisite for study participation
Who cannot join
- Known sensitivity to L-arabinose and grape marc extracts, or any sources of the active ingredients and excipients
- Use of medications or dietary supplements that may influence body weight 4 weeks, and gastrointestinal functions 2 weeks prior to enrolment and during the study
- Use of anti-diabetic medication
- Strenuous exercise within one day prior to blood glucose sampling (including screening).
- History of bariatric surgery, small bowel resection, or extensive bowel resection
- Difficult veins
Show all 16Show fewer
- Recent blood donation in the last 1 month prior to study
- Pregnancy or nursing
- Clinically relevant excursions of safety parameters
- Any other serious condition or disease that renders subjects ineligible
- Smoking
- Exceeding safe alcohol consumption (men: ≥ 21 units/week; women: ≥ 14 units/week) and any alcohol consumption within 24 hours before venous blood glucose sampling
- All vegetarians and subjects with self-reported diet high in fat or protein
- Subjects are not able to communicate with local study staff
- Recent antibiotic and cortisone use up to one week and during the study
- Participation in another study during the last 30 days of the screening visit (V1)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomised, Placebo-controlled, Three-way Crossover Clinical Investigation to Evaluate the Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects
In this trial, the investigational product , the active ingredients which has been proven to reduce postprandial glucose in healthy and diabetic patients, will be tested. The primary aim of this clinical study is to evaluate the possibility of the investigational product to reduce the rise of postprandial glucose AUC level in overweight Caucasian subjects with normal to prediabetic biomarkers (IFG/HbA1C), without prompting a disproportionate rise in insulin levels.
- Conditions
- Prediabetes, Hyperglycemia
- Being tested
- Dose 1 of IQP-VV-102, Dose 2 of IQP-VV-102, Placebo
- Medical subject headings
- Prediabetic State, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose 1 of IQP-VV-102Device
Dose 1 (D1) group will take 2 tablets with active ingredients and 2 placebo tablets.
Dose 2 of IQP-VV-102Device
Dose 2 (D2) group will take 4 tablets with active ingredients.
PlaceboDevice
Placebo group will take 4 placebo tablets.
The placebo is designed to be identical to IQP-VV-102.
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 of IQP-VV-102 | Active comparator | Total 4 tablets (2 tablets with active ingredients and 2 placebo tablets) to be taken, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water. Receives: Device: Dose 1 of IQP-VV-102 |
| Dose 2 of IQP-VV-102 | Active comparator | Total 4 tablets (4 tablets with active ingredients) to be taken, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water. Receives: Device: Dose 2 of IQP-VV-102 |
| Placebo | Placebo comparator | Total 4 placebo tablets, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in raised postprandial glucose (PPG) AUC levels of the verum groups (dose D1 and dose D2) compared against the placebo among normal to prediabetic overweight Caucasian subjects.
Measures raised PPG AUC levels (mmol/L) from 0-120 minutes on each visit
Measured: 120 minutes
Secondary outcomes (10)
Change in incremental PPG AUC level (mmol/L)
Measured from 0-120 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
Measured: 120 minutes
Change in total and incremental PPG AUC level (mmol/L)
Measured from 0th minute, to 60th, 90th and 180th minute after intake of verum or placebo on subjects on each of the 3 visit days.
Measured: 180 minutes
Changes in PPG concentration
Measured at 15, 30, 45, 60, 90, and 120 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
Measured: 180 minutes
Dose response of PPG level
Measured: Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
Change in total and incremental AUC insulin level (mmol/L)
Measured from 0th minute to 120th and 180th minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
Measured: 180 minutes
Dose response of insulin level
Measured: Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
Change in total and incremental AUC triglyceride level
Measured from 0-180 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
Measured: 180 minutes
Global evaluation of tolerability both by investigator and subjects
Global scaled evaluation with "very good", "good", "moderate" and "poor"
Measured: Throughout the study (8-14 days)
Incidence of adverse events (Safety parameters evaluation)
Eg. Liver Function Test, Lipid parameters, Renal Function Tests.
Measured: Throughout the study period (8-14 days)
Reported adverse events
For any adverse event, the term of the event, intensity, duration, seriousness, frequency, outcome and assessment of causality with the investigational product will be documented in the Case Report Form (CRF)
Measured: Throughout the whole study period (8-14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJun 2014
- Primary completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralf Uebelhack, PhD, Principal investigator, Charite
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541344
- Sponsor's protocol ID
- INQ/024613
- Status last verified
- Nov 2015
- First submitted
- 24 Aug 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Placebo-controlled, Three-way Crossover Clinical Investigation to Evaluate the Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects
- ClinicalTrials.gov ID
- NCT02541344
- Acronym / sponsor ID
- INQ/024613
- Conditions
- Prediabetes, Hyperglycemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Oct 2015 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this trial, the investigational product , the active ingredients which has been proven to reduce postprandial glucose in healthy and diabetic patients, will be tested. The primary aim of this clinical study is to evaluate the possibility of the investigational product to reduce the rise of postprandial glucose AUC level in overweight Caucasian subjects with normal to prediabetic biomarkers (IFG/HbA1C), without prompting a disproportionate rise in insulin levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 of IQP-VV-102 | Active comparator | Device: Dose 1 of IQP-VV-102Total 4 tablets (2 tablets with active ingredients and 2 placebo tablets) to be taken, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water. |
| Dose 2 of IQP-VV-102 | Active comparator | Device: Dose 2 of IQP-VV-102Total 4 tablets (4 tablets with active ingredients) to be taken, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water. |
| Placebo | Placebo comparator | Device: PlaceboTotal 4 placebo tablets, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Caucasian
- BMI between ≥ 25 and < 30 kg/m2
- Normal to prediabetic biomarkers: FBG 3.9-6.9 mmol/L / 70-125mg/dL and HbA1c 4-6.4%
- Willing to take test meal and adhere to consumptions of pre-prepared meals supplied (controlled by subject diary)
- Willing to maintain same level of physical activity during the study
Key exclusion criteria (16 listed)
- Known sensitivity to L-arabinose and grape marc extracts, or any sources of the active ingredients and excipients
- Use of medications or dietary supplements that may influence body weight 4 weeks, and gastrointestinal functions 2 weeks prior to enrolment and during the study
- Use of anti-diabetic medication
- Strenuous exercise within one day prior to blood glucose sampling (including screening).
- History of bariatric surgery, small bowel resection, or extensive bowel resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose 1 of IQP-VV-102Dose 1 (D1) group will take 2 tablets with active ingredients and 2 placebo tablets. | Device | Dose 1 of IQP-VV-102 |
| Dose 2 of IQP-VV-102Dose 2 (D2) group will take 4 tablets with active ingredients. | Device | Dose 2 of IQP-VV-102 |
| PlaceboPlacebo group will take 4 placebo tablets. The placebo is designed to be identical to IQP-VV-102. | Device | Placebo |
Primary outcome
Percentage change in raised postprandial glucose (PPG) AUC levels of the verum groups (dose D1 and dose D2) compared against the placebo among normal to prediabetic overweight Caucasian subjects.
Time frame: 120 minutes
Measures raised PPG AUC levels (mmol/L) from 0-120 minutes on each visit
10 secondary outcomes
Change in incremental PPG AUC level (mmol/L)
Time frame: 120 minutes
Change in total and incremental PPG AUC level (mmol/L)
Time frame: 180 minutes
Changes in PPG concentration
Time frame: 180 minutes
Dose response of PPG level
Time frame: Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
Change in total and incremental AUC insulin level (mmol/L)
Time frame: 180 minutes
Dose response of insulin level
Time frame: Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
Change in total and incremental AUC triglyceride level
Time frame: 180 minutes
Global evaluation of tolerability both by investigator and subjects
Time frame: Throughout the study (8-14 days)
Incidence of adverse events (Safety parameters evaluation)
Time frame: Throughout the study period (8-14 days)
Reported adverse events
Time frame: Throughout the whole study period (8-14 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
Related trials for Prediabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Uebelhack, PhD principal investigator
Charite
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dose 1 of IQP-VV-102 and Dose 2 of IQP-VV-102 in people with Prediabetes and Hyperglycemia, run by InQpharm Group at 1 site in Germany.
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 9 inclusion and 16 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 10 Nov 2015. 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage change in raised postprandial glucose (PPG) AUC levels of the verum groups (dose D1 and dose D2) compared against the placebo among normal to prediabetic overweight Caucasian subjects. (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2015.