Study to Evaluate the Safety and Tolerability of PBI-4050 in Type 2 Diabetes Patients With Metabolic Syndrome
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|ClinicalTrials.gov Identifier: NCT02562573|
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : April 11, 2017
This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050 800 mg daily oral administration in type 2 diabetes patients with metabolic syndrome.
A total of 12 patients will initially be enrolled for study participation. A Data Safety Monitoring Board (DSMB) will continuously review data obtained from the 12 patients. When the 12 patients have completed at least one month of study treatment, the DSMB will meet and determine whether additional patients may be enrolled or the study should be stopped. If the safety is deemed acceptable to continue with the study, the study will enroll a maximum of 36 patients.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Metabolic Syndrome||Drug: PBI4050||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Tolerability of PBI-4050 in Type 2 Diabetes Patients With Metabolic Syndrome|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Four 200 mg capsules (total 800 mg) administered orally, once a day.
- Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment [ Time Frame: 7 months ]
- Change from baseline on waist circumference [ Time Frame: 6 months ]
- Change from baseline on biomarkers [ Time Frame: 6 months ]% reduction and/or increase of biomarkers
- Change from baseline on antidiabetic treatment [ Time Frame: 6 months ]Treatment discontinued, dosing change, and/or new medication added
- Change from baseline on triglycerides [ Time Frame: 6 months ]
- Change from baseline on BP [ Time Frame: 6 months ]
- Change from baseline on HDL-C [ Time Frame: 6 Months ]
- Change from baseline on fasting plasma glucose [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562573
|Edmonton, Alberta, Canada|