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

NCT01835730 | Completed Phase 1

• 1 other identifier: PE0139-PT-CL-0001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 3

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)

Outcome Measures

Primary Outcomes (5)

• Change in Vital Signs from baseline (Day 0 Pre-dose)

  Safety will be evaluated by analyses of the change from baseline in vital signs.

  Vital signs Day 0, 1, 2, 3, 4, 5, 6, 7, 14 and 28

• Change in ECGs from baseline (Day -1)

  Safety will be evaluated by analyses of the change from baseline in 12-lead ECG.

  ECG Days 2 and 28

• Change in Safety Labs from baseline (Pre-dose)

  Safety will be evaluated by analyses of the safety laboratory parameters.

  Safety Labs Days 0, 7 and 28

• Incidence and severity of immunogenicity

  Safety will be evaluated by the incidence and severity of immunogenicity.

  Immunogenicity Days 0, 7, 14 and 28

• Incidence and severity of adverse events including hypoglycemia

  Safety will be evaluated by the incidence and severity of adverse events including hypoglycemia.

  As reported between Days -10 to 28

Secondary Outcomes (2)

• Pharmacokinetic Profile

  Day 0, 1, 2, 3, 4, 5, 6, and 7

• Pharmacodynamic Response

  FPG Day -10, -4, 0, 1, 2, 3, 4, 5, 6, 7, and 28; 4-pt Glucose and CGM - Day -10 to -7, -6, -5, and -4 to 7

Study Arms (2)

PE0139 Injection

EXPERIMENTAL

Single subcutaneous injection of PE0139, 40 mg/mL

Drug: PE0139 Injection

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

PE0139 Injection DRUG

PE0139 Injection

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PhaseBio Pharmaceuticals Inc.: lead

Study Sites (3)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Palm Springs Research Institute

Hialeah, Florida, 33012, United States

Location

Rainier Clinical Research

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ronald Brazg, MD

  Rainier Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 19, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

US (3)