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

NCT02060916 | Completed Phase 2

• 1 other identifier: PAZ320-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Treated With Insulin

Outcome Measures

Primary Outcomes (1)

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

  1 week

Secondary Outcomes (1)

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

  1 week

Study Arms (1)

PAZ320

EXPERIMENTAL

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

Interventions

PAZ320 DRUG

Single-center pilot study, open label dose escalation design

PAZ320

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Therapeutics: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Jefferson, New Hampshire, 03755, United States

Location

MeSH Terms

Interventions

PAZ320

Study Officials

• Laura E Trask, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: February 12, 2014
• Study Start: March 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 13, 2014

Record last verified: 2014-02

Locations

US (1)