Study to Evaluate the Safety and Tolerability of PBI-4050 in Type 2 Diabetes Patients With Metabolic Syndrome

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562573
• Other study ID #: PBI4050-ATX-9-04
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2015
• Last updated: April 10, 2017
• Start date: May 2015
• Est. completion date: November 2016

Study information

• Verified date: October 2016
• Source: ProMetic BioSciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This Phase 2 study will be performed by 1 site in Canada. The total duration of study participation for each patient is at least 18 weeks and comprises 6 study visits.

Patients who choose to participate in the extension study will be in the study for a total of up to 32 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient is 18 years of age or older.

2. Patient has signed written informed consent.

3. Patient has a clinical diagnosis of type 2 diabetes mellitus with a hemoglobin A1c (HbA1c) level between 7% and 10%.

4. Patient has been receiving stable antidiabetic therapy (oral agents with or without basal insulin given once daily in the evening) for a minimum of 3 months before the screening visit.

5. Patient is able and willing to self-monitor blood glucose level at home.

6. Patient has a body mass index (BMI) of at least 27 kg/m2.

7. Patient has metabolic syndrome, having at least 3 of the 5 metabolic syndrome risk factors.

Exclusion Criteria:

1. Patient requires intensive insulin therapy (defined as more than basal insulin given once daily in the evening) in addition to oral hypoglycemic agents for blood glucose control.

2. Patient has recent or on-going infection requiring systemic treatment with an anti-infective agent within 30 days before screening.

3. Patient has had at least one episode of severe hypoglycemia in the past 12 months, defined as having a blood glucose level < 3.0 mmol/L and/or requiring third party assistance to treat hypoglycemic episode.

4. Patient has evidence of significant cardiovascular disease, including myocardial infarction, unstable angina, coronary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), congestive heart failure (New York Heart Association Class III-IV), stroke, or severe ischemic disease within 3 months before screening.

5. Patient has uncontrolled hypertension with BP > 150/95 mm Hg.

6. Patient has a diagnosis of rheumatic or inflammatory disease, such as rheumatoid arthritis (RA), polymyalgia rheumatic (PMR), inflammatory bowel disease (IBD); or other autoimmune or inflammatory disease such as systemic lupus erythematosus (SLE) or psoriasis.

7. Patient is concurrently taking and plans to routinely continue taking anti-inflammatory medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids, during the study.

8. Patient is currently using weight loss medications.

9. Patient has significantly elevated liver enzyme levels, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.5 × upper limit of normal (ULN) or total bilirubin above ULN.

10. Patient has a history of chronic alcohol or other substance abuse.

11. Woman who is pregnant, breast-feeding, or planning a pregnancy during the course of the study.

12. Woman of childbearing potential who is unwilling to use adequate birth control throughout the duration of the study.

13. Patient has any condition that, in the investigator's opinion, is likely to interfere with study conduct and compliance.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome
• Type 2 Diabetes

Intervention

Drug:
• PBI4050

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ProMetic BioSciences Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment		7 months
Secondary	Change from baseline on waist circumference		6 months
Secondary	Change from baseline on biomarkers	% reduction and/or increase of biomarkers	6 months
Secondary	Change from baseline on antidiabetic treatment	Treatment discontinued, dosing change, and/or new medication added	6 months
Secondary	Change from baseline on triglycerides		6 months
Secondary	Change from baseline on BP		6 months
Secondary	Change from baseline on HDL-C		6 Months
Secondary	Change from baseline on fasting plasma glucose		6 months