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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Therapeutics
• Treatments: PAZ320

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