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

NCT ID: NCT02060916

Last Updated: 2014-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-08-31

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.

Detailed 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.

Conditions

Type 2 Diabetes Treated With Insulin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PAZ320

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.

Group Type: EXPERIMENTAL

PAZ320

Intervention Type: DRUG

Single-center pilot study, open label dose escalation design

Interventions

PAZ320

Single-center pilot study, open label dose escalation design

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura E Trask, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Jefferson, New Hampshire, United States

Countries

United States

Other Identifiers

PAZ320-002

Identifier Type: -

Identifier Source: org_study_id