Type 2 Diabetes MellitusPhase 2NCT02581657
Study to Assess the Safety, Tolerability, PK and PD Response of PE0139 Injection in Adult Subjects With T2DM
A Phase 2 study testing PE0139 Injection in people with Type 2 Diabetes Mellitus, run by PhaseBio Pharmaceuticals Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- PE0139 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2015to Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to sign a written informed consent and follow all study-related procedures;
- 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 last dose of study drug;
- Body mass index ≥ 18 kg/m2 and ≤ 45 kg/m2;
- Diagnosed with T2DM with HbA1c of ≥ 7.5% and <11.0% and who is currently taking a non-insulin antidiabetic therapy at stable dose(s) for 3 months prior to screening;
- Willing and able to comply with all study procedures including wearing a continuous glucose monitoring device and performance of frequent self-monitored blood glucose profiles according to the protocol;
- Minimum 7-day average daily glucose of 154 mg/dL (based on CGM) at baseline evaluation;
- Willing to refrain from taking acetaminophen (paracetamol) containing products (e.g., Tylenol®) 24 hours prior to the placement of the CGM device and throughout the time period when the CGM device is worn;
- Live and work in an area with reliable Verizon cellular service for transmission of glucose data required for use of the Telcare Glucose Monitoring System.
Who cannot join
- Clinical diagnosis of Type 1 diabetes;
- Currently taking or have routinely taken, within 6 months prior to screening, a long or short-acting insulin;
- Self-reported significant change in weight defined as either a loss or gain ≥ 10% during the three month period prior to screening or between screening and randomization;
- 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 in concomitant medication usage during the study period;
- Self-reported history of severe hypoglycemia or hypoglycemic unawareness, as judged by the Investigator;
Show all 17Show fewer
- Self-reported history of acute complications secondary to diabetes within the last 6 months prior to screening or signs or symptoms of clinically significant diabetes related complications prior to screening;
- Malignant disease defined as: Self-reported history of malignant melanoma or breast cancer; Self-reported history of other types of cancer (excludes basal/squamous cell carcinoma or cervical carcinoma if treated and condition not currently active) within the last 5 years prior to screening;
- Unstable cardiovascular disease defined as one or more of the following: Self-reported history of stroke, transient ischemic attack, or myocardial infarction within 6 months prior to screening; Self-reported history of or currently have NYHA Class III-IV heart failure prior to screening; Self-reported history of unstable angina within 3 months prior to screening; Uncontrolled/sustained hypertension; Self-reported history of clinically significant ECG abnormalities or evidence of clinically significant ECG abnormalities;
- Clinically significant renal and/or hepatic dysfunction noted on safety labs;
- Absolute requirement for corticosteroids or have routinely received systemic steroids within 12 months prior to randomization or use of inhaled corticosteroids within 1 month prior to randomization. A single short course treatment of systemic steroids to treat an acute infection will not exclude the subject if taken more than 3 months from screening;
- Pregnant or lactating female subjects;
- Known history of alcohol abuse or use of illicit drugs within 1 year prior to screening, and/or who test positive for alcohol and illicit drugs prior to randomization. Note: A subject will be considered in violation of the study if they test positive prior to any planned dosing and will be discontinued from the study;
- Positive screening for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies at screening;
- Previously received PE0139;
- Participating in any other study and have received any other investigational medication or device within 30 days prior to screening or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with the outcome of the study;
- Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk or would preclude obtaining voluntary consent or would confound the secondary objectives of the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Meridien Research
Bradenton, Florida, 34208
Indago Research and Health Center, Inc.
Hialeah, Florida, 33012
National Research Institute
Huntington Park, California, 90255
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119
Rainier Clinical Research
Renton, Washington, 98057
About this study
Official title: 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
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.
Read the 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
- Being tested
- PE0139 Injection, Placebo Injection
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PE0139 InjectionDrug
PE0139 Injection
Placebo InjectionDrug
Placebo Injection
| Study group | Role | What they receive |
|---|---|---|
| PE0139 Injection | Experimental | PE0139 Subcutaneous Injection - 6 weekly doses Receives: Drug: PE0139 Injection |
| Placebo Injection | Placebo comparator | Placebo Subcutaneous Injection - 6 weekly doses Receives: Drug: Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability (as assessed by incidence and severity of adverse events (AEs), hypoglycemia and changes from baseline in vital signs, ECGs and safety laboratory parameters).
To evaluate the safety and tolerability (as assessed by incidence and severity of AEs, hypoglycemia and changes from baseline in vital signs, ECGs and safety laboratory parameters) of multiple ascending doses of PE0139 administered as once weekly injection for 6 weeks in adults with T2DM.
Measured: AEs and hypoglycemia (Day -60 to 63), Vital signs (Days -60, -10, 0, 7, 14, 21, 28, 35, 42, 49 and 63), safety laboratory parameters (-60, -10, 14, 28, 42, 49 (as needed), and 63) ECGs (-60, -10, 14, 28, 42, 49 (as needed) and 63).
Secondary outcomes (14)
Pharmacokinetic (PK) profile - Area under the curve over the dosing interval (AUC (0-t))
Characterize the PK profile of PE0139 following 6 weeks repeat, once-weekly dosing to explore dose response relationship.
Measured: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacokinetic (PK) profile - Area under the curve concentration-time profile from 0 to Tmax [AUC (0-tmax)] and from Tmax to t [AUC(tmax-t]
Characterize the PK profile of PE0139 following 6 weeks repeat, once-weekly dosing to explore dose response relationship.
Measured: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacokinetic (PK) profile - Maximum serum concentration (Cmax)
Characterize the PK profile of PE0139 following 6 weeks repeat, once-weekly dosing to explore dose response relationship.
Measured: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacokinetic (PK) profile - Time to Cmax (Tmax)
Characterize the PK profile of PE0139 following 6 weeks repeat, once-weekly dosing to explore dose response relationship.
Measured: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacokinetic (PK) profile - Elimination Rate Constant (Lamda z)
Characterize the PK profile of PE0139 following 6 weeks repeat, once-weekly dosing to explore dose response relationship.
Measured: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacokinetic (PK) profile - Elimination half-life (t1/2)
Characterize the PK profile of PE0139 following 6 weeks repeat, once-weekly dosing to explore dose response relationship.
Measured: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacokinetic (PK) profile - Clearance (CL/F), uncorrected for bioavailability
Characterize the PK profile of PE0139 following 6 weeks repeat, once-weekly dosing to explore dose response relationship.
Measured: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacokinetic (PK) profile - Volume of Distribution (Vz/F), uncorrected for bioavailability
Characterize the PK profile of PE0139 following 6 weeks repeat, once-weekly dosing to explore dose response relationship.
Measured: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacodynamic (PD) Profile - Change from baseline in fasting plasma glucose
Characterize the PD response of various doses of PE0139 and glucose (as assessed by fasting and non-fasting plasma glucose)
Measured: PD response measured as fasting plasma glucose (FPG) (daily by subject up to day 21 and Days -60, between days -10 and -7, 0, 1-7, 14, 21, 28, 35, 36-49 and 63 at CRU)
Pharmacodynamic (PD) Profile - Change from baseline in average glucose by CGM
Characterize the PD response of various doses of PE0139 and glucose (as assessed by CGM)
Measured: PD response measured by continuous glucose monitoring (CGM) (baseline collected ≥7 days pre-dose daily after dose 3 for 4 weeks)
Fructosamine changes
Assess the effect of various doses of PE0139 on change in fructosamine following 6 weeks of repeat, once-weekly dosing.
Measured: Measured at pre-dose and 7 days after last dose
Required dose adjustment to background therapy
Assess the incidence for required dose adjustment to background therapy across various doses of PE0139 and compared to placebo.
Measured: All scheduled and unscheduled visits (Days -60 to 63)
Reported hypoglycemic events (% of subjects experiencing severe and non-severe hypoglycemic events)
Describe incidence, severity, and duration of reported hypoglycemic events across various doses of PE0139 and compared to placebo. Reported as % of subjects experiencing a hypoglycemic event (severe (requiring medical assistance or ≤36 mg/dL glucose) or non-severe (not requiring medical assistance and <70mg/dL glucose))
Measured: All scheduled and unscheduled visits (Days -60 to 63)
Binding anti-drug antibodies to PE0139 and insulin (as needed). If positive, neutralizing activity will also be assessed.
Characterize the immunogenicity profile (binding drug antibodies to PE0139 and insulin (as needed) and neutralizing antibodies if noted to be positive) following 6 weeks of repeat, once-weekly dosing.
Measured: Collected at Pre-dose, Days 7, 14, 21, 28, 35, 42, 49, 63 and 91.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhaseBio Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581657
- Sponsor's protocol ID
- PE0139-PT-CL-0002
- Status last verified
- Apr 2018
- First submitted
- 9 Oct 2015
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02581657
- Acronym / sponsor ID
- PE0139-PT-CL-0002
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- PhaseBio Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PE0139 Injection | Experimental | Drug: PE0139 InjectionPE0139 Subcutaneous Injection - 6 weekly doses |
| Placebo Injection | Placebo comparator | Drug: Placebo InjectionPlacebo Subcutaneous Injection - 6 weekly doses |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to sign a written informed consent and follow all study-related procedures;
- 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 last dose of study drug;
- Body mass index ≥ 18 kg/m2 and ≤ 45 kg/m2;
- Diagnosed with T2DM with HbA1c of ≥ 7.5% and <11.0% and who is currently taking a non-insulin antidiabetic therapy at stable dose(s) for 3 months prior to screening;
- Willing and able to comply with all study procedures including wearing a continuous glucose monitoring device and performance of frequent self-monitored blood glucose profiles according to the protocol;
Key exclusion criteria (17 listed)
- Clinical diagnosis of Type 1 diabetes;
- Currently taking or have routinely taken, within 6 months prior to screening, a long or short-acting insulin;
- Self-reported significant change in weight defined as either a loss or gain ≥ 10% during the three month period prior to screening or between screening and randomization;
- 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 in concomitant medication usage during the study period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PE0139 InjectionPE0139 Injection | Drug | PE0139 Injection |
| Placebo InjectionPlacebo Injection | Drug | Placebo Injection |
Primary outcome
Safety and tolerability (as assessed by incidence and severity of adverse events (AEs), hypoglycemia and changes from baseline in vital signs, ECGs and safety laboratory parameters).
Time frame: AEs and hypoglycemia (Day -60 to 63), Vital signs (Days -60, -10, 0, 7, 14, 21, 28, 35, 42, 49 and 63), safety laboratory parameters (-60, -10, 14, 28, 42, 49 (as needed), and 63) ECGs (-60, -10, 14, 28, 42, 49 (as needed) and 63).
To evaluate the safety and tolerability (as assessed by incidence and severity of AEs, hypoglycemia and changes from baseline in vital signs, ECGs and safety laboratory parameters) of multiple ascending doses of PE0139 administered as once weekly injection for 6 weeks in adults with T2DM.
14 secondary outcomes
Pharmacokinetic (PK) profile - Area under the curve over the dosing interval (AUC (0-t))
Time frame: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacokinetic (PK) profile - Area under the curve concentration-time profile from 0 to Tmax [AUC (0-tmax)] and from Tmax to t [AUC(tmax-t]
Time frame: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacokinetic (PK) profile - Maximum serum concentration (Cmax)
Time frame: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacokinetic (PK) profile - Time to Cmax (Tmax)
Time frame: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacokinetic (PK) profile - Elimination Rate Constant (Lamda z)
Time frame: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacokinetic (PK) profile - Elimination half-life (t1/2)
Time frame: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacokinetic (PK) profile - Clearance (CL/F), uncorrected for bioavailability
Time frame: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacokinetic (PK) profile - Volume of Distribution (Vz/F), uncorrected for bioavailability
Time frame: PK measured for Dose 1 (pre-dose, 1, 3, 6 hours post-dose, daily for 6 days), Doses 2-5 given on days 7, 14, 21 and 28, respectively, (pre-dose) and Dose 6 (pre-dose, 1, 3 and 6 hours post dose, daily for 10 days and 14 days post-dose).
Pharmacodynamic (PD) Profile - Change from baseline in fasting plasma glucose
Time frame: PD response measured as fasting plasma glucose (FPG) (daily by subject up to day 21 and Days -60, between days -10 and -7, 0, 1-7, 14, 21, 28, 35, 36-49 and 63 at CRU)
Pharmacodynamic (PD) Profile - Change from baseline in average glucose by CGM
Time frame: PD response measured by continuous glucose monitoring (CGM) (baseline collected ≥7 days pre-dose daily after dose 3 for 4 weeks)
Fructosamine changes
Time frame: Measured at pre-dose and 7 days after last dose
Required dose adjustment to background therapy
Time frame: All scheduled and unscheduled visits (Days -60 to 63)
Reported hypoglycemic events (% of subjects experiencing severe and non-severe hypoglycemic events)
Time frame: All scheduled and unscheduled visits (Days -60 to 63)
Binding anti-drug antibodies to PE0139 and insulin (as needed). If positive, neutralizing activity will also be assessed.
Time frame: Collected at Pre-dose, Days 7, 14, 21, 28, 35, 42, 49, 63 and 91.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
Related trials for Type 2 Diabetes Mellitus
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PE0139 Injection in people with Type 2 Diabetes Mellitus, run by PhaseBio Pharmaceuticals Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (as assessed by incidence and severity of adverse events (AEs), hypoglycemia and changes from baseline in vital signs, ECGs and safety laboratory parameters). (time frame: AEs and hypoglycemia (Day -60 to 63), Vital signs (Days -60, -10, 0, 7, 14, 21, 28, 35, 42, 49 and 63), safety laboratory parameters (-60, -10, 14, 28, 42, 49 (as needed), and 63) ECGs (-60, -10, 14, 28, 42, 49 (as needed) and 63).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.