ObesityGLIDENCT03124134
Gelesis Glycemic Index Study
A study testing Gelesis200 in people with Obesity and Diabetes, run by Gelesis, Inc. at 1 site in Canada.
Trial summary
A study to determine glucose and insulin responses to 50g and 100 g of carbohydrate with and without Gelesis200. Read more about this study
- Who is it for?
- Ages 22 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes, PreDiabetes
- What is being tested?
- Gelesis200
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 18 Apr 2017to 18 May 2017
- Phase
- Interventional
- 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 22 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male.
- Non-smoker (no use of tobacco products within 6 months prior to screening), ≥ 22 and ≤ 65 years of age, with body mass index (BMI) ≥ 18.5 and < 30.0 kg/m2.
- Healthy as defined by:
- the absence of clinically significant illness and surgery within 12 weeks prior to administration. Subjects vomiting within 24 hours pre-administration will be carefully evaluated for upcoming illness/disease. Inclusion pre-administration is at the discretion of the Qualified Investigator.
- the absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease, including, but not limited to pancreatitis, hepatitis B or C, HIV, swallowing disorders, and gastroesophageal reflux disease (at least 1 episode per week).
- the absence of clinically significant history of gastric or peptic ulcer, small bowel resection (except if related to appendectomy), intestinal stricture (e.g., Crohn's disease), intestinal obstruction or high risk of intestinal obstruction including suspected small bowel adhesions.
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- the absence of clinically significant history or known presence of esophageal anatomic abnormalities (e.g., webs, diverticuli, rings), gastroparesis, and malabsorption.
- the absence of history of gastric bypass, any other gastric surgery and intragastric balloon.
- the absence of history of angina, coronary bypass, and myocardial infarction within 6 months prior to administration.
- the absence of history of abdominal radiation treatment.
- the absence of history of cancer within the past 5 years, except adequately-treated localized basal cell skin cancer.
- Capable of consent.
- Fasting plasma glucose < 100 mg/dL (< 5.6 mmol/L) and fasting insulin < 10 μIU/mL (< 69.5 pmol/L) at screening.
- Ability and willingness to consume 3 slices of white bread within 10 minutes and 6 slices of white bread within 15 minutes.
Who cannot join
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- Positive urine drug screen at screening.
- History of allergic reactions to carboxymethylcellulose, citric acid, gelatin, titanium dioxide, or other related substances.
- Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
- Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
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- History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first IP administration, administration of a biological product in the context of a clinical research study within 90 days prior to the first IP administration, or concomitant participation in an investigational study involving no drug or device administration.
- Use of medication other than topical products without significant systemic absorption:
- prescription medication within 30 days prior to the first administration;
- over-the-counter products and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to the first administration, with the exception of the occasional use of acetaminophen (up to 2 g daily);
- a depot injection or an implant of any drug within 3 months prior to the first administration.
- Donation of plasma within 7 days prior to administration. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL within 30 days, or more than 499 mL within 56 days prior to the first administration.
- Hemoglobin < 128 g/L and hematocrit < 0.37 L/L at screening.
- Glycosylated hemoglobin (HbA1c) ≥ 6.5% (≥ 48 mmol/mol) at screening.
- Serum low-density lipoprotein cholesterol ≥ 190 mg/dL (≥ 4.93 mmol/L) at screening.
- Serum triglycerides ≥ 500 mg/dL (≥ 5.65 mmol/L) at screening.
- Abnormal TSH at screening, or abnormal free T4 if TSH is slightly out of range.
- Anticipating surgical intervention during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Crossover Study Assessing the Effects of Gelesis200 on Glucose and Insulin Following a Single Administration of Gelesis200 in Healthy Subjects
A study to determine glucose and insulin responses to 50g and 100 g of carbohydrate with and without Gelesis200.
Read the detailed description
This will be a single centre, open-label, randomized, single-administration, 4-period, 4-way, crossover, pilot study with glycemic and insulin assessments. There is also an option for 2 additional single-administration periods based on the results of an interim analysis.
The study includes 2 treatments arms with Gelesis200 (4.20 g 10 minutes before a 50 g carbohydrate breakfast and 4.20 g 10 minutes before a 100 g carbohydrate breakfast) plus 2 control arms consisting of consumption of the breakfasts with water only.
The optional periods consist of 1 treatment arm with Gelesis200 and 1 control arm with breakfast and water only. Either only one or both the optional periods may be conducted. The number of additional period(s) to conduct, the amount of Gelesis200 in the treatment arm, as well as the meal composition will be based on interim analysis results.
- Conditions
- Obesity, Diabetes, PreDiabetes
- Being tested
- Gelesis200, Water, only (placebo)
- Medical subject headings
- Obesity, Diabetes Mellitus, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelesis200Device
Encapsulated hydrogel
Water, only (placebo)Other
300 mL of water
| Study group | Role | What they receive |
|---|---|---|
| A) Gelesis200, 50 g carbs | Experimental | 4.20 g of Gelesis200 before a 50 g carbohydrate breakfast Receives: Device: Gelesis200 |
| B) Gelesis200, 100 g carbs | Experimental | 4.20 g of Gelesis200 before a 100 g carbohydrate breakfast Receives: Device: Gelesis200 |
| C) Water, 50 g carbs | Placebo comparator | 300 mL water before a 50 g carbohydrate breakfast Receives: Other: Water, only (placebo) |
| D) Water, 100 g carbs | Placebo comparator | 300 mL water before a 100 g carbohydrate breakfast Receives: Other: Water, only (placebo) |
| E) Gelesis200, TBD carbs | Experimental | up to 4.20 g Gelesis200 before a meal of either 50 g or 100 g carbohydrate breakfast (to be determined after interim analysis) Receives: Device: Gelesis200 |
| F) Water, TBD carbs | Placebo comparator | 300 mL of water before a meal of either 50 g or 100 g carbohydrate breakfast (to be determined after interim analysis) Receives: Other: Water, only (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
AEs, lab abnormalities
Measured: single administration on each of up to 6 days over 6 weeks
Secondary outcomes (2)
Post prandial glucose
iAUC of glucose after a carbohydrate containing meal
Measured: single administration on each of up to 6 days over 6 weeks
Post prandial insulin
iAUC of insulin after a carbohydrate containing meal
Measured: single administration on each of up to 6 days over 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start18 Apr 2017
- Primary completion18 May 2017
- Study completion18 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 4-way crossover with the option for 2 more crossover arms after interim analysis
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gelesis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- inVentiv Health Clinical
- Responsible party
- Sponsor
- Investigators
- Audet, Principal investigator, inVentiv Health Clinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124134
- Sponsor's protocol ID
- GS-200-005
- Other IDs
- 160159
- Acronym
- GLIDE
- Status last verified
- Feb 2018
- First submitted
- 18 Apr 2017
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Crossover Study Assessing the Effects of Gelesis200 on Glucose and Insulin Following a Single Administration of Gelesis200 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03124134
- Acronym / sponsor ID
- GLIDE / GS-200-005
- Conditions
- Obesity, Diabetes, PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gelesis, Inc.Industry (pharma, biotech, devices)
- Collaborators
- inVentiv Health Clinical
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 18 May 2017 (actual)
- Study completion
- 18 May 2017 (actual)
- First posted
- 21 Apr 2017 (actual)
- 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.
A study to determine glucose and insulin responses to 50g and 100 g of carbohydrate with and without Gelesis200.
Detailed description
This will be a single centre, open-label, randomized, single-administration, 4-period, 4-way, crossover, pilot study with glycemic and insulin assessments. There is also an option for 2 additional single-administration periods based on the results of an interim analysis.
The study includes 2 treatments arms with Gelesis200 (4.20 g 10 minutes before a 50 g carbohydrate breakfast and 4.20 g 10 minutes before a 100 g carbohydrate breakfast) plus 2 control arms consisting of consumption of the breakfasts with water only.
The optional periods consist of 1 treatment arm with Gelesis200 and 1 control arm with breakfast and water only. Either only one or both the optional periods may be conducted. The number of additional period(s) to conduct, the amount of Gelesis200 in the treatment arm, as well as the meal composition will be based on interim analysis results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 4-way crossover with the option for 2 more crossover arms after interim analysis
| Arm | Type | Receives |
|---|---|---|
| A) Gelesis200, 50 g carbs | Experimental | Device: Gelesis2004.20 g of Gelesis200 before a 50 g carbohydrate breakfast |
| B) Gelesis200, 100 g carbs | Experimental | Device: Gelesis2004.20 g of Gelesis200 before a 100 g carbohydrate breakfast |
| C) Water, 50 g carbs | Placebo comparator | Other: Water, only (placebo)300 mL water before a 50 g carbohydrate breakfast |
| D) Water, 100 g carbs | Placebo comparator | Other: Water, only (placebo)300 mL water before a 100 g carbohydrate breakfast |
| E) Gelesis200, TBD carbs | Experimental | Device: Gelesis200up to 4.20 g Gelesis200 before a meal of either 50 g or 100 g carbohydrate breakfast (to be determined after interim analysis) |
| F) Water, TBD carbs | Placebo comparator | Other: Water, only (placebo)300 mL of water before a meal of either 50 g or 100 g carbohydrate breakfast (to be determined after interim analysis) |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male.
- Non-smoker (no use of tobacco products within 6 months prior to screening), ≥ 22 and ≤ 65 years of age, with body mass index (BMI) ≥ 18.5 and < 30.0 kg/m2.
- Healthy as defined by:
- Capable of consent.
- Fasting plasma glucose < 100 mg/dL (< 5.6 mmol/L) and fasting insulin < 10 μIU/mL (< 69.5 pmol/L) at screening.
Key exclusion criteria (19 listed)
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- Positive urine drug screen at screening.
- History of allergic reactions to carboxymethylcellulose, citric acid, gelatin, titanium dioxide, or other related substances.
- Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
- Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
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 |
|---|---|---|
| Gelesis200Encapsulated hydrogel | Device | A) Gelesis200, 50 g carbs, B) Gelesis200, 100 g carbs, E) Gelesis200, TBD carbs |
| Water, only (placebo)300 mL of water | Other | C) Water, 50 g carbs, D) Water, 100 g carbs, F) Water, TBD carbs |
Primary outcome
Safety and Tolerability
Time frame: single administration on each of up to 6 days over 6 weeks
AEs, lab abnormalities
2 secondary outcomes
Post prandial glucose
Time frame: single administration on each of up to 6 days over 6 weeks
Post prandial insulin
Time frame: single administration on each of up to 6 days over 6 weeks
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 15 Feb 2018.
- Individual participant dataSharing planned: No. The individual data will not be available to other researchers.
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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.
Audet principal investigator
inVentiv Health Clinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelesis200 in people with Obesity and Diabetes, run by Gelesis, Inc. at 1 site in Canada.
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 14 inclusion and 19 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 15 Feb 2018. 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 Canada. 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.
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?
Safety and Tolerability (time frame: single administration on each of up to 6 days over 6 weeks). 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 15 Feb 2018.