- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02060916
Study to Evaluate the Safety and Efficacy of PAZ320 in Patients With Type 2 Diabetes (PAZ320)
February 12, 2014 updated by: Boston Therapeutics
Study to Evaluate the Safety and Efficacy of PAZ320 When Added to Oral Agents or Insulin in Patients With Type 2 Diabetes Mellitus
This study is to evaluate the effect that PAZ320 has on post-prandial glucose excursions measured via continuous glucose monitoring and its adverse effect profile in humans.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this study, the investigators seek to evaluate the effect that PAZ320 has on post-prandial glucose excursions measured via continuous glucose monitoring and its adverse effect profile in humans.
Continuous glucose monitors (CGM) are minimally invasive devices that measure glucose levels in interstitial fluid.
A small wire is inserted subcutaneously which transmits the ambient subcutaneous glucose concentration every 5 minutes to a wireless recorder.
In usual use, the patient can see these data and graph the previous 1, 3 or 9 hours to identify trends or look back over time (ie over night).
In our study, the patient will be blinded to the data so as not to confound results, as it has been noted in another study that patient's blood sugar control was better when they were able to see CGM results and modified their diet.
CGM's have been shown to have clinical accuracies of 95.5-98.9% and have been used in clinical trials and found to be safe.
Having the patient do a finger-stick glucose intermittently during the time they are wearing the CGM improves accuracy.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Hampshire
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Dartmouth, New Hampshire, United States, 03755
- Dartmouth-Hitchcock Medical Center
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female subjects, aged 18-75 years;
- Subjects diagnosed with Type 2 Diabetes mellitus;
- Subjects currently on oral agents or insulin;
- Body mass index 25 to 40 kg/m2;
- Subjects able to comply with study procedures and sign informed consent
- A1c less than or equal to 9%
Exclusion Criteria:
- Medication (other than diabetes medications or insulin) or dietary supplement known to affect glucose or galactose metabolism
- Use of acetaminophen-containing products
- Lactose or galactose intolerance
- History of eating disorder
- Food allergy or severe food intolerance
- Pregnant or lactating female
- Subjects with diabetes mellitus treated with very high dose of sulfonylureas (glyburide>20 mg/day, , glimepiride >8 mg per day, and glipizide >20 mg per day) α-glucosidase inhibitors (acarbose ), or meglitinides (repaglinide >6 mg per day)), ;
- Subject with gastrointestinal disease that may interfere with absorption of the investigational products at discretion of investigator, including but are not limited to malabsorption syndromes and gastric ulcer;
- Subject has received any investigational agent within 30 days prior to the first dose of investigational product
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PAZ320
Patients will all take part in the control arm of the study and then be crossed over into treatment with PAZ320 at two different dosages.
|
Single-center pilot study, open label dose escalation design
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the efficacy of the food supplement PAZ320 on post-prandial glucose excursion
Time Frame: 1 week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laura E Trask, MD, Dartmouth-Hitchcock Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
November 18, 2013
First Submitted That Met QC Criteria
February 11, 2014
First Posted (Estimate)
February 12, 2014
Study Record Updates
Last Update Posted (Estimate)
February 13, 2014
Last Update Submitted That Met QC Criteria
February 12, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAZ320-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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