Impaired Glucose TolerancePhase 1NCT01468376
GLU-xx Formulations in Individuals With Impaired Glucose Tolerance
A Phase 1 study testing GLU-01, GLU-02 and GLU-03 in people with Impaired Glucose Tolerance, run by Afexa Life Sciences Inc at 1 site in United States.
Trial summary
The purpose of this study is to determine a safe,tolerable and efficacious dose of GLU-xx. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- GLU-01, GLU-02 and GLU-03
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jan 2012
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy adults between 21-65 years of age
- Body Mass Index (BMI) between 25 and ≤40
- OGTT (75g glucola) peak value between ≥140mg/dl and ≤199 mg/dl at screening visit
- Willingness to adhere to the requirements of the protocol, including availability for follow-up visits and donation of blood samples
- Willingness and ability to sign written informed consent
- Women of child bearing capacity who agree to use an acceptable form of birth control during the trial [i.e., oral contraception, reliable use of a double-barrier method (e.g., condom and diaphragm, condom and foam, condom and sponge), IUD or tubal ligation]
Who cannot join
- Active diabetes mellitus [fasting blood glucose of ≥7.0 mmol/L (≥126 mg/dL) or ≥11.1 mmol/L (≥200 mg/dL) after OGTT]
- Current coronary artery/ cardiovascular disease or history of a cardiovascular event (stroke, transient ischemic attack, myocardial infarction, angioplasty or coronary artery bypass grafting, angina pectoris) or have undergone a cardiovascular intervention within the past three months
- Seizure disorder
- Blood disorders, including anemia (i.e., hemoglobin levels less than 13 g/dL in men and less than 12 g/dL in women)
- Active infection, including HIV, hepatitis, etc
- Participants on Estrogen replacement must be on a stable dose for at least 3 months
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- Serious illness requiring ongoing medical care or medication
- Gastrointestinal disorders or prior gastrointestinal surgeries (including gastric bypass or lap-band) that might cause complications or influence motility or satiety (e.g.,diverticulitis, inflammatory bowel disease, irritable bowel syndrome, intestinal narrowing or obstruction, difficulty swallowing)
- Any congenital spinal cord deformities or traumatic spinal cord injuries
- Uncorrected hypothyroidism
- Other significant metabolic endocrine disease
- Active liver disease or liver function impairment as evidenced by a history of liver disease or liver enzyme elevations >three times the upper limit of normal
- Current cancer
- Significant kidney disease (calculated by eGFR <60 mL/min)
- History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological,or psychiatric disorders which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject
- Use of anticoagulants such as warfarin
- Use of medications that might affect weight or food absorption (e.g., diuretics,glucocorticoids, anorexigenic agents, Orlistat, laxatives)
- Treatment within the previous 6 months with any medication that is known to affect glucose levels (such as insulin with or without an amylin analogue, sulfonylureas,meglitinides, biguanide metformin, thiazolidinediones, alpha-glucosidase inhibitors,oral dipeptidyl-peptidase-4 inhibitor, Sitagliptin, Incretin mimetic)
- Regular use of natural health products or dietary supplements known to affect glucose levels (such as chromium, zinc, fenugreek, cinnamon). If the participant agrees to stop taking these products 14 days prior to study entry and for the duration of the study, they can participate in the study
- o Any other natural health products or dietary supplements, with the exception of vitamins and minerals with dose of < 600 mg/day of vitamin E and containing no vitamin K. Natural health products or dietary supplements include products such as, but not limited to, Echinacea, Ginseng, St. John's Wort, Gingko, Glucosamine, Fish Oil supplements, Evening Primrose Oil, Green Tea or other herbal products consumed in the form of pills, extracts, capsules, or tablets. If the participant agrees to stop taking these products 14 days prior to study entry and for the duration of the study, they can participate in the study
- Vegan or Vegetarian
- Pregnant or lactating women, or intending to become pregnant
- Known allergy to any ingredient in the study product
- Any significant auto-immune disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Dose-finding Pilot Study of Various Formulations of Glucose-lowering Products in Otherwise Healthy Individuals With Impaired Glucose Tolerance
The purpose of this study is to determine a safe,tolerable and efficacious dose of GLU-xx.
- Conditions
- Impaired Glucose Tolerance
- Being tested
- GLU-01, GLU-02, GLU-03, GLU-04, GLU-05
- Keywords
- impaired glucose tolerance, pre-diabetes
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLU-01Dietary supplement
14 day dosing
GLU-02Dietary supplement
14 day dosing
GLU-03Dietary supplement
14 day dosing
GLU-04Dietary supplement
14 day dosing
GLU-05Dietary supplement
14 day dosing
GLU-06Dietary supplement
14 day dosing
| Study group | Role | What they receive |
|---|---|---|
| GLU-01 | Experimental | Not described Receives: Dietary Supplement: GLU-01 |
| GLU-02 | Experimental | Not described Receives: Dietary Supplement: GLU-02 |
| GLU-03 | Experimental | Not described Receives: Dietary Supplement: GLU-03 |
| GLU-04 | Experimental | Not described Receives: Dietary Supplement: GLU-04 |
| GLU-05 | Experimental | Not described Receives: Dietary Supplement: GLU-05 |
| GLU-06 | Experimental | Not described Receives: Dietary Supplement: GLU-06 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose and insulin response to the Oral Glucose Tolerance Test after administration of GLU-xx formulations
Measured: 14 days
Secondary outcomes (1)
Safety and tolerability of GLU-xx formulations
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Sponsor company was acquired and new owner chose not to proceed with clinical study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Glucose ToleranceStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afexa Life Sciences Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Udani, MD, Principal investigator, Medicus Research LLC/Staywell Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468376
- Sponsor's protocol ID
- GLU-00-2010-1
- Status last verified
- Jan 2012
- First submitted
- 7 Nov 2011
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-finding Pilot Study of Various Formulations of Glucose-lowering Products in Otherwise Healthy Individuals With Impaired Glucose Tolerance
- ClinicalTrials.gov ID
- NCT01468376
- Acronym / sponsor ID
- GLU-00-2010-1
- Conditions
- Impaired Glucose Tolerance
- Keywords
- impaired glucose tolerance, pre-diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor company was acquired and new owner chose not to proceed with clinical study
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Afexa Life Sciences IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Nov 2011 (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.
The purpose of this study is to determine a safe,tolerable and efficacious dose of GLU-xx.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GLU-01 | Experimental | Dietary Supplement: GLU-01 |
| GLU-02 | Experimental | Dietary Supplement: GLU-02 |
| GLU-03 | Experimental | Dietary Supplement: GLU-03 |
| GLU-04 | Experimental | Dietary Supplement: GLU-04 |
| GLU-05 | Experimental | Dietary Supplement: GLU-05 |
| GLU-06 | Experimental | Dietary Supplement: GLU-06 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Generally healthy adults between 21-65 years of age
- Body Mass Index (BMI) between 25 and ≤40
- OGTT (75g glucola) peak value between ≥140mg/dl and ≤199 mg/dl at screening visit
- Willingness to adhere to the requirements of the protocol, including availability for follow-up visits and donation of blood samples
- Willingness and ability to sign written informed consent
Key exclusion criteria (24 listed)
- Active diabetes mellitus [fasting blood glucose of ≥7.0 mmol/L (≥126 mg/dL) or ≥11.1 mmol/L (≥200 mg/dL) after OGTT]
- Current coronary artery/ cardiovascular disease or history of a cardiovascular event (stroke, transient ischemic attack, myocardial infarction, angioplasty or coronary artery bypass grafting, angina pectoris) or have undergone a cardiovascular intervention within the past three months
- Seizure disorder
- Blood disorders, including anemia (i.e., hemoglobin levels less than 13 g/dL in men and less than 12 g/dL in women)
- Active infection, including HIV, hepatitis, etc
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 |
|---|---|---|
| GLU-0114 day dosing | Dietary supplement | GLU-01 |
| GLU-0214 day dosing | Dietary supplement | GLU-02 |
| GLU-0314 day dosing | Dietary supplement | GLU-03 |
| GLU-0414 day dosing | Dietary supplement | GLU-04 |
| GLU-0514 day dosing | Dietary supplement | GLU-05 |
| GLU-0614 day dosing | Dietary supplement | GLU-06 |
Primary outcome
Glucose and insulin response to the Oral Glucose Tolerance Test after administration of GLU-xx formulations
Time frame: 14 days
1 secondary outcome
Safety and tolerability of GLU-xx formulations
Time frame: 14 Days
Results and safety
The study was stopped early (reason given: Sponsor company was acquired and new owner chose not to proceed with clinical study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
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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.
Jay Udani, MD principal investigator
Medicus Research LLC/Staywell Research LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLU-01, GLU-02 and GLU-03 in people with Impaired Glucose Tolerance, run by Afexa Life Sciences Inc at 1 site in United States.
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 24 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 31 Jan 2012. 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 United States. 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 was stopped early (reason given: Sponsor company was acquired and new owner chose not to proceed with clinical study). 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?
Glucose and insulin response to the Oral Glucose Tolerance Test after administration of GLU-xx formulations (time frame: 14 days). 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 31 Jan 2012.