NCT02581657

Study to Assess the Safety, Tolerability, PK and PD Response of PE0139 Injection in Adult Subjects With T2DM

Phase 2a Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: PhaseBio Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind (Investigator and study subject), placebo controlled multiple dose sequential ascending dose study that will enroll up to 47 male and female subjects with type 2 diabetes mellitus (T2DM) in up to four cohorts.

Detailed description

This study is a randomized, double-blind (Investigator and study subject), placebo controlled multiple dose sequential ascending dose study that will enroll up to 47 male and female subjects with T2DM in up to four cohorts; (6 active/2 placebo subjects in cohort 1, and up to 9 active/4 placebo in each subsequent cohort). This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic response of PE0139 in the presence of existing stable non-insulin antidiabetic background therapy. Subjects will return weekly for a total of 6 doses of study drug. Study remains active, not recruiting as subjects who received active study drug will be followed for secondary outcome measures.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	PE0139 Injection	PE0139 Injection
DRUG	Placebo Injection	Placebo Injection

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-10-21
• Last updated: 2018-04-10

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study