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Type II Diabetes MellitusPhase 3NCT01644201

A Study Evaluating the Effects of a High Viscosity Non-starch Polysaccharide (PolyGlycopleX® - PGX®) on Glycemic Control, Cardiometabolic Risk Factors and Weight Loss in Overweight and Obese Type II Diabetics

A Phase 3 study testing PolyGlycopleX® - PGX® in people with Type II Diabetes Mellitus and Obesity, run by InovoBiologic Inc. at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

One out of two adults in Canada is currently overweight and therefore at increased risk for a number of medical conditions including diabetes, high blood pressure, heart attacks and stroke. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type II Diabetes Mellitus, Obesity
What is being tested?
PolyGlycopleX® - PGX®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteCanada
Study dates
Oct 2012to Nov 2016
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75 years of age (if >65 years of age, enrolment at the discretion of qualified investigator)
  • BMI 27-60 Kg/m2
  • Stable Type 2 diabetes mellitus (i.e. no medication change in the last 3 months)
  • Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation

Who cannot join

  • HbA1c <7.0% or >10.0%
  • History of any bariatric surgery
  • >10 Kg weight gain or weight loss in the past 3 months
  • Known eating disorder
  • Participant has taken weight loss medication in the last 3 months (eg. Meridia, Xenical)
  • Participant is taking any of the following medications that can alter body weight or appetite:
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  • Antipsychotics or neuroleptics
  • Prednisone
  • Antidepressants
  • Tricyclic such as amitriptyline, imipramine (Tofranil), and doxepin (Sinequan)
  • Monoamine oxidase inhibitors (MAOIs) such as tranylcypromine, (Parnate), isocarboxazid (Marplan) and phenelzine (Nardil)
  • Tetracyclic such as Mirtazapine (Remeron)
  • Serotonin antagonist and reuptake inhibitors (SARI) such as Trazodone
  • Note: The following antidepressants are NOT exclusion medications:
  • SSRIs such as citalopram (Celexa), escitalopram (Lexapro), fluvoxamine (Luvox), fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil)
  • Wellbutrin
  • SNRIs such as venlafaxine (Effexor), duloxetine (Cymbalta)
  • Participant is taking any of the following natural health products that can alter body weight or appetite: ephedra, synephrine, green tea extracts, daily use of bulk fibre laxatives (e.g. psyllium, glucomannan)
  • Participant not eligible for enrolment in a medically supervised LCD program at the Wharton Medical Clinic (WMC only accepts patients by referral from a family physician. To be eligible patients must have a BMI ≥ 30 or ≥ 27 with at least one obesity related comorbidity.)
  • Patient with a past history of severe hypoglycaemia (as defined by the Diabetes Control and Complications Trial (DCCT)) whether or not on insulin, sulfonylureas and non-sulfonylurea secretogogues
  • Patient with documented hypoglycemic unawareness, whether or not on insulin, sulfonylureas and non-sulfonylurea secretogogues
  • Achalasia (i.e. difficulty swallowing)
  • Patient is taking medication that targets GLP-1 (glucagon-like peptide-1) including GLP-1 analogues (e.g. Byetta (Exenatide), Victoza (Liraglutide)) and DPP-IV inhibitors (e.g. Januvia(Sitagliptin), Onglyza (Saxagliptin).
  • Positive urine pregnancy test, pregnancy, breast feeding, or hormonal contraceptives started in the last 6 months prior to the start of the study
  • Absence of a highly effective method of birth control for female of childbearing potential (premenopausal or not surgically sterile) OR does not plan to use contraception for the duration of study participation AND does not agree to periodic urine pregnancy testing during the study. ICH M3 defines a highly effective method of birth control as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
  • Substance abuse: tobacco (including those who have quit smoking in the last 12 months), Cannabis sativa, or other controlled substances use
  • Any allergies to study product ingredients including dairy, whey, rice, soy and or coconut.
  • Labile or uncontrolled hypertension (SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg)
  • Current diagnosis or history of gastrointestinal diseases or disorders (with the exception of Irritable Bowel Syndrome and GERD at the discretion of qualified investigator).
  • Heart failure
  • Substantial neurological or psychological illness within the last 6 months (at the discretion of qualified investigator)
  • Contraindications to LCD
  • any major surgery that is, at the time of screening, planned to take place during the study
  • history of drug or alcohol dependency within six months prior to signing the informed consent form.
  • history of active malignancy (exceptions at the discretion of qualified investigator e.g. squamous cell carcinoma), chronic inflammatory disorder, or chronic infections which would interfere with protocol completion
  • history of CV event or angina within 6 months (with the exception of stable angina at the discretion of qualified investigator)
  • history of active gall bladder disease where the gallbladder was not removed
  • inflammatory bowel disease
  • type 1 diabetes
  • significant renal impairment eGFR < 50
  • porphyria
  • cirrhosis
  • patients deemed unable to comprehend or comply with the diet and/or,
  • unable to attend program follow up visits
  • Participant cannot fully understand all instructions in English.
  • Any other medical, social or geographic condition, which, in the opinion of the qualified investigator would not allow safe completion of the protocol.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Wharton Medical Clinic and Weight Management Centre

    Hamilton, Ontario

Other trials in Canada

About this study

Official title: A Randomized, Double Blind, Placebo Controlled Trial Evaluating the Effects of a Highly Viscous Non-starch Polysaccharide (PolyGlycopleX® - PGX®), on Glycemic Control, Cardiometabolic Risk Factors and Weight Loss in Overweight and Obese Type II Diabetics Enrolled in a Medically Supervised Weight Management Program.

One out of two adults in Canada is currently overweight and therefore at increased risk for a number of medical conditions including diabetes, high blood pressure, heart attacks and stroke. Obesity is less prevalent in populations consuming large amounts of dietary fibre, suggesting that fibre intake could play an important role in prevention and progression of obesity and diabetes and other conditions. Several studies have suggested that fibre has a positive effect on blood sugar and may help lower body weight.

The purpose of this study is to help better understand the effect of adding fibre supplementation to a low calorie diet on blood sugar control and weight loss. The investigators hypothesize that blood sugar control will improve in participants in the fibre supplementation group.

Men and women, with stable Type 2 Diabetes (e.g. no medication change in the last 3 months), between 18 - 75 years of age, and with a Body Mass Index (BMI) between 27 - 60 kg/m2 can participate in this study.

Being tested
PolyGlycopleX® - PGX®, Rice Flour (placebo)
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

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

  • PolyGlycopleX® - PGX®Dietary supplement

    15g or 20g total daily dose, 5g pre-mixed with liquid meal replacement and consumed twice daily, 5g supplement granules sprinkled on food and consumed once of twice daily

  • Rice Flour (placebo)Dietary supplement

    15g or 20g total daily dose, 5g pre-mixed with liquid meal replacement and consumed twice daily, 5g supplement granules sprinkled on food and consumed once of twice daily

Study groups in NCT01644201
Study groupRoleWhat they receive
High viscosity non-starch polysaccharide, PolyGlycopleX®-PGX®Active comparatorNot described
Receives: Dietary Supplement: PolyGlycopleX® - PGX®
Placebo (Rice Flour)Placebo comparatorNot described
Receives: Dietary Supplement: Rice Flour (placebo)

What is being measured

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

  1. HbA1c

    Measured: End of study (1 year)

Timeline

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

  1. First posted19 Jul 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionNov 2016
  4. Study completionNov 2016

Why it stopped: Too slow recruitment

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01644201
Sponsor's protocol ID
Wharton Study No. 05
Status last verified
Aug 2015
First submitted
16 Jul 2012
Last updated
11 Feb 2021
Results posted
No
Data monitoring committee
No

Publications

  • Reimer RA, Wharton S, Green TJ, Manjoo P, Ramay HR, Lyon MR, Gahler RJ, Wood S. Effect of a functional fibre supplement on glycemic control when added to a year-long medically supervised weight management program in adults with type 2 diabetes. Eur J Nutr. 2021 Apr;60(3):1237-1251. doi: 10.1007/s00394-020-02328-8. Epub 2020 Jul 8.

    PubMed 32642971

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PolyGlycopleX® - PGX® in people with Type II Diabetes Mellitus and Obesity, run by InovoBiologic 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 4 inclusion and 46 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: stopped early, as of the sponsor's last update on 11 Feb 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 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.

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 was stopped early (reason given: Too slow recruitment). Results are not available in the source record.

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?

HbA1c (time frame: End of study (1 year)). 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 NCT01644201, 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 11 Feb 2021.

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