Clinical trial NCT01835730: 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
Official title: Phase 1 Multicenter, Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: PhaseBio Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change in Vital Signs from baseline (Day 0 Pre-dose)
timeFrame: Vital signs Day 0, 1, 2, 3, 4, 5, 6, 7, 14 and 28
measure: Change in ECGs from baseline (Day -1)
timeFrame: ECG Days 2 and 28
measure: Change in Safety Labs from baseline (Pre-dose)
timeFrame: Safety Labs Days 0, 7 and 28
measure: Incidence and severity of immunogenicity
timeFrame: Immunogenicity Days 0, 7, 14 and 28
measure: Incidence and severity of adverse events including hypoglycemia
timeFrame: As reported between Days -10 to 28
Secondary outcomes:
measure: Pharmacokinetic Profile
timeFrame: Day 0, 1, 2, 3, 4, 5, 6, and 7
measure: Pharmacodynamic Response
timeFrame: 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
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Hialeah
country: United States
facility: Palm Springs Research Institute
state: Florida
city: Renton
country: United States
facility: Rainier Clinical Research
state: Washington
Study officials:
affiliation: Rainier Clinical Research
name: Ronald Brazg, MD
role: PRINCIPAL_INVESTIGATOR
References: