Phase 1 Multicenter, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus

NCT ID: NCT01835730

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-05-31

Brief Summary

This study is a first-in-human randomized, double-blind (Investigator and subject), placebo controlled single ascending dose study that will enroll approximately 40 (6 active/2 placebo per dose group) adult male and female subjects with Type 2 Diabetes Mellitus (T2DM).

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PE0139 Injection

Single subcutaneous injection of PE0139, 40 mg/mL

Group Type: EXPERIMENTAL

PE0139 Injection

Intervention Type: DRUG

Placebo

Single subcutaneous injection of 0.9% Sodium Chloride (NaCl) (Placebo)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

PE0139 Injection

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Willing and able to sign a written informed consent and follow all study-related procedures;
• Male and female subjects at least 18 years of age;
• Male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their dose of study drug;
• Body mass index ≤45 kg/m2;
• Diagnosed with T2DM and who is currently taking a stable daily dose of a basal insulin (Lantus) plus at least one oral antihyperglycemic agent at a stable dose for 3 months prior to screening.

Exclusion Criteria

• Currently taking or have taken within 3 months prior to screening an approved or investigational GLP-1 analogue/agonist (e.g., Victoza®) or pramlintide;
• Currently taking or have routinely taken, within 3 months prior to screening , a short-acting insulin;
• Currently taking or have taken, within 3 months prior to screening, a long acting insulin other than Lantus®;
• Known allergy to, or serious adverse effect caused by an approved, or investigational insulin product or any of its components;
• Currently taking any of the following medications: thiazide or furosemide diuretics, beta-blockers, estrogens or other hormonal replacement therapy, or other chronic medications with known adverse effects on glucose tolerance levels unless the subject has been on stable doses of such agents for at least 2 months prior to screening and have no planned changes during the study period;
• History of recurrent severe hypoglycemia (more than 2 episodes within the last 6 months prior to randomization or hypoglycemic unawareness;
• Malignant disease defined as 1) any history of malignant melanoma or breast cancer and/or 2) history of other types of cancer within the last 5 years prior to screening;
• Unstable cardiovascular disease defined as one or more of the following: History of stroke, transient ischemic attack, or myocardial infarction within 6 months prior to screening; History of or currently have New York Heart Association Class III-IV heart failure prior to screening; Uncontrolled/sustained hypertension; History or evidence of long QT syndrome or mean triplicate 12-lead electrocardiogram demonstrating QT interval;
• Clinically significant renal and/or hepatic dysfunction;
• Absolute requirement for corticosteroids or have received systemic steroids within 3 months prior to Randomization (V5, Day -1). Note: Use of inhaled or topical corticosteroids will be permitted;
• Pregnant or lactating female subjects;
• Known history of or active alcohol abuse or use of illicit drugs within 1 year prior to screening;
• Positive screening for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies at V1;
• Participating in any other study and have received any other investigational medication or device within 30 days prior to Visit 1.
• Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PhaseBio Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Brazg, MD

Role: PRINCIPAL_INVESTIGATOR

Rainier Clinical Research

Locations

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Palm Springs Research Institute

Hialeah, Florida, United States

Rainier Clinical Research

Renton, Washington, United States

Countries

United States

Other Identifiers

PE0139-PT-CL-0001

Identifier Type: -

Identifier Source: org_study_id