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

Completed · Phase 2

Conditions studied: Type 2 Diabetes Treated With Insulin

In brief

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.

Key facts

Study ID

NCT02060916

Run by

Boston Therapeutics

People needed

24

Starts

2011-03-01

Expected to finish

2011-08-01

Last updated by the study team

2014-02-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Dartmouth-Hitchcock Medical Center — Jefferson, New Hampshire, United States

Full record on ClinicalTrials.gov

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