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
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|ClinicalTrials.gov Identifier: NCT01835730|
Recruitment Status : Completed
First Posted : April 19, 2013
Last Update Posted : October 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus (T2DM)||Drug: PE0139 Injection Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||April 2013|
|Primary Completion Date :||May 2014|
|Study Completion Date :||May 2014|
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)
- 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 ]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 ]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 ]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 ]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 ]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 ]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 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|