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

Type 2 Diabetes Treated With Insulin Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060916
• Other study ID #: PAZ320-002
• Status: Completed
• Phase: Phase 2
• First received: November 18, 2013
• Last updated: February 12, 2014
• Start date: March 2011
• Est. completion date: August 2011

Study information

• Verified date: February 2014
• Source: Boston Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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) a-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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Treated With Insulin

Intervention

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

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Dartmouth	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Boston Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of the food supplement PAZ320 on post-prandial glucose excursion		1 week	No
Secondary	Number of Subjects with Adverse Events as a Measure of Safety and Tolerability		1 week	No