Gelesis Glycemic Index Study

NCT03124134 | Completed

• 2 other identifiers: GS-200-005160159
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A study to determine glucose and insulin responses to 50g and 100 g of carbohydrate with and without Gelesis200.

Conditions

Obesity; Diabetes; PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  AEs, lab abnormalities

  single administration on each of up to 6 days over 6 weeks

Secondary Outcomes (2)

• Post prandial glucose

  single administration on each of up to 6 days over 6 weeks

• Post prandial insulin

  single administration on each of up to 6 days over 6 weeks

Study Arms (6)

A) Gelesis200, 50 g carbs

EXPERIMENTAL

4.20 g of Gelesis200 before a 50 g carbohydrate breakfast

Device: Gelesis200

B) Gelesis200, 100 g carbs

EXPERIMENTAL

4.20 g of Gelesis200 before a 100 g carbohydrate breakfast

Device: Gelesis200

C) Water, 50 g carbs

PLACEBO COMPARATOR

300 mL water before a 50 g carbohydrate breakfast

Other: Water, only (placebo)

D) Water, 100 g carbs

PLACEBO COMPARATOR

300 mL water before a 100 g carbohydrate breakfast

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)

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)

Other: Water, only (placebo)

Interventions

Gelesis200 DEVICE

Encapsulated hydrogel

A) Gelesis200, 50 g carbs; B) Gelesis200, 100 g carbs; E) Gelesis200, TBD carbs

Water, only (placebo) OTHER

300 mL of water

C) Water, 50 g carbs; D) Water, 100 g carbs; F) Water, TBD carbs

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• 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.

You may not qualify if:

• 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 \[1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\]).
• 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.

Sponsors & Collaborators

• Gelesis, Inc.: lead
• inVentiv Health Clinical: collaborator

Study Sites (1)

inVentiv Health Clinique

Québec, Canada

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Prediabetic State

Interventions

Water; Single Person

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Audet

  inVentiv Health Clinique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 4-way crossover with the option for 2 more crossover arms after interim analysis

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 21, 2017
• Study Start: April 18, 2017
• Primary Completion: May 18, 2017
• Study Completion: May 18, 2017
• Last Updated: February 15, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)