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

Primary Purpose

Type 2 Diabetes Treated With Insulin

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

PAZ320

About this trial

This is an interventional treatment trial for Type 2 Diabetes Treated With Insulin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PAZ320

Arm Description

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.

Outcomes

Primary Outcome Measures

To evaluate the efficacy of the food supplement PAZ320 on post-prandial glucose excursion

Secondary Outcome Measures

Number of Subjects with Adverse Events as a Measure of Safety and Tolerability

Full Information

NCT ID

NCT02060916

First Posted

November 18, 2013

Last Updated

February 12, 2014

Sponsor

Boston Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT02060916

Brief Title

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

Acronym

PAZ320

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 Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Treated With Insulin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PAZ320

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

PAZ320

Intervention Description

Single-center pilot study, open label dose escalation design

Primary Outcome Measure Information:

Title

To evaluate the efficacy of the food supplement PAZ320 on post-prandial glucose excursion

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Number of Subjects with Adverse Events as a Measure of Safety and Tolerability

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura E Trask, MD

Organizational Affiliation

Dartmouth-Hitchcock Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dartmouth-Hitchcock Medical Center

City

Dartmouth

State/Province

New Hampshire

ZIP/Postal Code

03755

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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