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

Boston Therapeutics

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Treated With Insulin

Treatments

Drug: PAZ320

Study type

Interventional

Funder types

Industry

Identifiers

NCT02060916

PAZ320-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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