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Study to Evaluate the Safety and Efficacy of PAZ320 in Patients With Type 2 Diabetes (PAZ320)

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ClinicalTrials.gov Identifier: NCT02060916
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : February 13, 2014
Sponsor:
Information provided by (Responsible Party):
Boston Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Treated With Insulin Drug: PAZ320 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study to Evaluate the Safety and Efficacy of PAZ320 When Added to Oral Agents or Insulin in Patients With Type 2 Diabetes Mellitus
Study Start Date : March 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


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.
Drug: PAZ320
Single-center pilot study, open label dose escalation design




Primary Outcome Measures :
  1. To evaluate the efficacy of the food supplement PAZ320 on post-prandial glucose excursion [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060916


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Dartmouth, New Hampshire, United States, 03755
Sponsors and Collaborators
Boston Therapeutics
Investigators
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Principal Investigator: Laura E Trask, MD Dartmouth-Hitchcock Medical Center

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Responsible Party: Boston Therapeutics
ClinicalTrials.gov Identifier: NCT02060916     History of Changes
Other Study ID Numbers: PAZ320-002
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases