Type 2 Diabetes Mellitus (T2DM)Phase 1NCT01835730
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
A Phase 1 study testing PE0139 Injection in people with Type 2 Diabetes Mellitus (T2DM), run by PhaseBio Pharmaceuticals Inc. at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- 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
- 3 sitesUnited States
- Study dates
- Apr 2013to May 2014
- Phase
- Phase 1
- 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 65 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 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Palm Springs Research Institute
Hialeah, Florida, 33012
Rainier Clinical Research
Renton, Washington, 98057
About this study
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
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).
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- PE0139 Injection, Placebo
- 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| PE0139 Injection | Experimental | Single subcutaneous injection of PE0139, 40 mg/mL Receives: Drug: PE0139 Injection |
| Placebo | Placebo comparator | Single subcutaneous injection of 0.9% Sodium Chloride (NaCl) (Placebo) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vital Signs from baseline (Day 0 Pre-dose)
Safety will be evaluated by analyses of the change from baseline in vital signs.
Measured: Vital signs Day 0, 1, 2, 3, 4, 5, 6, 7, 14 and 28
Change in ECGs from baseline (Day -1)
Safety will be evaluated by analyses of the change from baseline in 12-lead ECG.
Measured: ECG Days 2 and 28
Change in Safety Labs from baseline (Pre-dose)
Safety will be evaluated by analyses of the safety laboratory parameters.
Measured: Safety Labs Days 0, 7 and 28
Incidence and severity of immunogenicity
Safety will be evaluated by the incidence and severity of immunogenicity.
Measured: Immunogenicity Days 0, 7, 14 and 28
Incidence and severity of adverse events including hypoglycemia
Safety will be evaluated by the incidence and severity of adverse events including hypoglycemia.
Measured: As reported between Days -10 to 28
Secondary outcomes (2)
Pharmacokinetic Profile
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)
Measured: Day 0, 1, 2, 3, 4, 5, 6, and 7
Pharmacodynamic Response
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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- Investigators
- Ronald Brazg, MD, Principal investigator, Rainier Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835730
- Sponsor's protocol ID
- PE0139-PT-CL-0001
- Status last verified
- Oct 2014
- First submitted
- 28 Mar 2013
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01835730
- Acronym / sponsor ID
- PE0139-PT-CL-0001
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- PhaseBio Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 19 Apr 2013 (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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PE0139 Injection | Experimental | Drug: PE0139 InjectionSingle subcutaneous injection of PE0139, 40 mg/mL |
| Placebo | Placebo comparator | Drug: PlaceboSingle subcutaneous injection of 0.9% Sodium Chloride (NaCl) (Placebo) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
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 Injection | Drug | PE0139 Injection |
| Placebo | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Pharmacokinetic Profile
Time frame: Day 0, 1, 2, 3, 4, 5, 6, and 7
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
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 15 Oct 2014.
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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.
Ronald Brazg, MD principal investigator
Rainier Clinical Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PE0139 Injection in people with Type 2 Diabetes Mellitus (T2DM), run by PhaseBio Pharmaceuticals Inc. at 3 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 5 inclusion and 15 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 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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). The study lists 5 primary outcomes in all. 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 15 Oct 2014.