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
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).
Type 2 Diabetes Mellitus (T2DM)
Drug: PE0139 Injection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Change in Vital Signs from baseline (Day 0 Pre-dose) [ Time Frame: Vital signs Day 0, 1, 2, 3, 4, 5, 6, 7, 14 and 28 ] [ Designated as safety issue: Yes ]Safety will be evaluated by analyses of the change from baseline in vital signs.
- Change in ECGs from baseline (Day -1) [ Time Frame: ECG Days 2 and 28 ] [ Designated as safety issue: Yes ]Safety will be evaluated by analyses of the change from baseline in 12-lead ECG.
- Change in Safety Labs from baseline (Pre-dose) [ Time Frame: Safety Labs Days 0, 7 and 28 ] [ Designated as safety issue: Yes ]Safety will be evaluated by analyses of the safety laboratory parameters.
- Incidence and severity of immunogenicity [ Time Frame: Immunogenicity Days 0, 7, 14 and 28 ] [ Designated as safety issue: Yes ]Safety will be evaluated by the incidence and severity of immunogenicity.
- Incidence and severity of adverse events including hypoglycemia [ Time Frame: As reported between Days -10 to 28 ] [ Designated as safety issue: Yes ]Safety will be evaluated by the incidence and severity of adverse events including hypoglycemia.
- Pharmacokinetic Profile [ Time Frame: Day 0, 1, 2, 3, 4, 5, 6, and 7 ] [ Designated as safety issue: No ]Pharmacokinetic parameters include: Area under the concentration curve from time 0 to infinity (AUC(0-inf)), Area under the concentration curve to the final sample with a concentration greater than or equal to Limit of Quantitation (LOQ) (AUC(0-t)), Time to maximum concentration (Tmax), Maximum serum concentration (Cmax), Elimination rate constant (Lambda-z), Elimination half-life (t1/2), Clearance uncorrected for bioavailability (CL/F), Distribution uncorrected for bioavailability (Vz/F)
- Pharmacodynamic Response [ Time Frame: 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 ] [ Designated as safety issue: No ]To assess the pharmacodynamic response (time action profile) of various single doses of PE0139. Assessments include Fasting plasma glucose (FPG), 4-point serial glucose monitoring and glucose assessed by continuous glucose monitoring (CGM).
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: PE0139 Injection
Single subcutaneous injection of PE0139, 40 mg/mL
|Drug: PE0139 Injection|
Placebo Comparator: Placebo
Single subcutaneous injection of 0.9% Sodium Chloride (NaCl) (Placebo)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01835730
|United States, Alabama|
|Pinnacle Research Group, LLC|
|Anniston, Alabama, United States, 36207|
|United States, Florida|
|Palm Springs Research Institute|
|Hialeah, Florida, United States, 33012|
|United States, Washington|
|Rainier Clinical Research|
|Renton, Washington, United States, 98057|
|Principal Investigator:||Ronald Brazg, MD||Rainier Clinical Research|