Diabetes Mellitus, Type 1Phase 2NCT04074317
Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D
A Phase 2 study testing PRAM9, Regular Insulin + Pramlintide and Regular Insulin in people with Diabetes Mellitus, Type 1 and Insulin-dependent Diabetes Mellitus, run by Xeris Pharmaceuticals at 1 site in United States.
Trial summary
This is a randomized, open-label, active-controlled, single-dose, 3-treatment, 3-period, 3-way crossover, comparative PD and PK inpatient study in adults with T1D. The study comprises 5 visits: Screening (Visit 1), Treatment Periods (Visits 2 - 4), and Follow-Up (Visit 5). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Insulin-dependent Diabetes Mellitus
- What is being tested?
- PRAM9, Regular Insulin + Pramlintide and Regular Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2019to 2 Apr 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Understands the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent
- Male or non-pregnant, non-lactating female diagnosed with T1D for at least 24 months prior to Screening.
- Aged 18 to 64 years of age, inclusive
- On a stable insulin regimen for 21 days prior to Screening (no greater than ± 20% variability in total daily dose)
- Have a plasma C-peptide level < 0.6 ng/mL at Screening
- Have an HbA1c < 10% at Screening
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- Body mass index (BMI) in the range of ≥ 18 to ≤ 35 kg/m2 at Screening
- For women of childbearing potential, there is a requirement for a negative urine pregnancy test at Screening and for agreement to use contraception throughout the study and for 7 days after the last dose of study drug. Acceptable contraception includes birth control pill/patch/vaginal ring, Depo-Provera® (medroxyprogesterone acetate), Norplant® System (levonorgestrel), an intra-uterine device (IUD), the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- Fasting Serum triglyceride concentration < 200 mg/dL
Who cannot join
- Currently being treated with pramlintide or has discontinued pramlintide within 21 days of Screening
- Currently using an insulin pump
- Has renal insufficiency (serum creatinine <3.0 mg/dL) or end-stage renal disease requiring renal replacement therapy
- Has hepatic disease, including serum ALT or AST ≥3 times the upper limit of normal (ULN)
- Has hepatic synthetic insufficiency (serum albumin <3.0 g/dL)
- Has a hematocrit value that is exclusionary: Female <35.5% and Male <38.3%
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- Has a hemoglobin value that is exclusionary: Female <11.5 g/dL and Male <12.5 g/dL
- Has out-of-range systolic or diastolic BP readings at Screening (systolic BP <90 or >150 mm Hg or diastolic BP <50 or >100 mm Hg)
- Has clinically significant ECG abnormalities at Screening
- Has congestive heart failure, NYHA Class III or IV
- Has history of myocardial infarction, unstable angina, or revascularization within 6 months prior to Screening
- Has history of a cerebrovascular accident in 6 months prior to Screening with major neurological deficits
- Has active malignancy within 5 years prior to Screening (exception: basal cell or squamous cell skin cancers)
- Has had major surgical operation within 60 days prior to Screening or planned surgical operation during the study
- Has a seizure disorder (other than with suspected or documented hypoglycemia)
- Has a current bleeding disorder, treatment with anticoagulants, or platelet count <50 ×10^9/L
- Has a history of allergies or significant hypersensitivity to pramlintide or any pramlintide-related products or to any of the excipients in the investigational formulation
- Has a history of positive test result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- Has a concurrent illness not controlled by a stable therapeutic regimen
- Tests positive for drugs of abuse at Screening. Subjects testing positive for tetrahydrocannabinol (THC) at Screening or reporting active marijuana use will be allowed to participate in the study at the discretion of the investigator.
- Has active substance or alcohol abuse (>21 drinks/week for males or >14 drinks/week for females)
- Has participated in other studies involving administration of an investigational drug within 30 days or 5 half-lives prior to Screening (whichever is longer) or during participation in the current study
- There is any reason the investigator deems exclusionary
- Has donated blood within 8 weeks prior to Screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
World Wide Clinical Trials
San Antonio, Texas, 78217
About this study
Official title: A Phase 2, Single-Dose, Randomized, Open-Label, Active-Controlled, Crossover, Pharmacodynamic, and Pharmacokinetic Comparative Study of a Novel Pramlintide-Insulin Co-Formulation in Adults With Type 1 Diabetes Mellitus
This is a randomized, open-label, active-controlled, single-dose, 3-treatment, 3-period, 3-way crossover, comparative PD and PK inpatient study in adults with T1D. The study comprises 5 visits: Screening (Visit 1), Treatment Periods (Visits 2 - 4), and Follow-Up (Visit 5).
Read the detailed description
The primary objective of this study is to evaluate the PD properties of a single dose of PRAM9 compared to single doses of regular insulin and regular insulin plus pramlintide (co-administered as separate injections) in adults with T1D. The secondary objectives of this study are to evaluate the safety and PK profiles of a single dose of PRAM9 compared to single doses of regular insulin and regular insulin plus pramlintide (co-administered as separate injections) in adults with T1D. During each treatment period subjects will receive a single SC dose of PRAM9, regular insulin, or co-administered regular insulin plus pramlintide.
- Being tested
- PRAM9, Regular Insulin + Pramlintide, Regular Insulin
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRAM9Drug
SC injection
Regular Insulin + PramlintideDrug
Separate SC injections
Regular InsulinDrug
SC injection
| Study group | Role | What they receive |
|---|---|---|
| PRAM9 to Regular Insulin to Regular Insulin+pramlintide | Experimental | Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin (Humulin®) to Regular Insulin+pramlintide (Symlin® pen) as separate SC injections Receives: Drug: PRAM9; Drug: Regular Insulin + Pramlintide; Drug: Regular Insulin |
| Regular Insulin to Regular Insulin+pramlintide to PRAM9 | Experimental | Regular Insulin (Humulin®) to Regular Insulin+pamlintide (Symlin® pen) as separate SC injections to PRAM9 Receives: Drug: PRAM9; Drug: Regular Insulin + Pramlintide; Drug: Regular Insulin |
| Regular Insulin+pramlintide to PRAM9 to Regular Insulin | Experimental | Regular Insulin (Humulin®)+pramlintide (Symlin® pen) as separate SC injections to Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin Receives: Drug: PRAM9; Drug: Regular Insulin + Pramlintide; Drug: Regular Insulin |
| PRAM9 to Regular Insulin+pramlintide to Regular Insulin | Experimental | Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin (Humulin®)+pramlintide (Symlin® pen) as separate SC injections to Regular Insulin Receives: Drug: PRAM9; Drug: Regular Insulin + Pramlintide; Drug: Regular Insulin |
| Regular Insulin to PRAM9 to Regular Insulin+pramlintide | Experimental | Regular Insulin (Humulin®) to Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin+pramlintide (Symlin® pen) as separate SC injections to Regular Insulin Receives: Drug: PRAM9; Drug: Regular Insulin + Pramlintide; Drug: Regular Insulin |
| Regular Insulin+pramlintide to Regular Insulin to PRAM9 | Experimental | Regular Insulin (Humulin®)+pramlintide (Symlin® pen) as separate SC injections to Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin to Xeris pramlintide + insulin co-formulation (PRAM9) Receives: Drug: PRAM9; Drug: Regular Insulin + Pramlintide; Drug: Regular Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL
The PD effects on plasma glucose levels were compared among the treatment arms as defined by AUC0-180 (mg/dL * minutes) for plasma glucose >180 mg/dL
Measured: 0-180 minutes following administration of study drug
Secondary outcomes (12)
Mean Proportional Time for Plasma Glucose Levels
The mean proportional times were evaluated for the following Plasma Glucose Levels: >180 mg/dL, >250 mg/dL, <54 mg/dL, and <70 The mean proportional times evaluated for each Plasma Glucose Level were during the following post-study drug injection periods: 0 to 90 minutes, 0 to 180 minutes, 0 to 360 minutes
Measured: Up to 360 minutes following administration of study drug
Mean Proportional Time After Glucose Challenge for Plasma Glucose Levels Between 126 to 180 mg/dL
The mean proportional times to plasma glucose levels between 126 to 180 mg/dL following a glucose challenge administered 30 minutes post study drug administration.
Measured: During 40 to 180 minutes post-injection of study drug
Area Under the Concentration (AUC) Curve for Plasma Glucose
AUC0-t (mg/dL*minutes) for plasma glucose X mg/dL, in which X = (>180 mg/dL, >250 mg/dL) and t = 90, 180, and 360 minutes
Measured: Up to 360 minutes following administration of study drug
Area Over the Concentration (AOC) Curve for Plasma Glucose
AOC0-t (mg/dL*minutes) for plasma glucose X mg/dL, in which X = <54 mg/dL and <70 mg/dL and t = 90, 180, and 360 minutes
Measured: Up to 360 minutes following administration of study drug
Plasma Glucose Cmax
The maximum measured glucose concentrations over the time span.
Measured: Up to 360 minutes following administration of study drug
Plasma Glucose Tmax
The time to maximum measured glucose concentrations.
Measured: Up to 360 minutes following administration of study drug
Pramlintide Cmax
The maximum measured pramlintide concentrations (arithmetic mean).
Measured: Up to 360 minutes following administration of study drug
Pramlintide Tmax
The time to maximum measured pramlintide concentrations.
Measured: Up to 360 minutes following administration of study drug
Pramlintide Area Under the Concentration (AUC) Curve
The pramlintide area under the concentration time curve after study drug administration (arithmetic mean).
Measured: Up to 360 minutes following administration of study drug
Insulin Cmax
The maximum measured insulin concentrations (arithmetic mean)
Measured: Up to 360 minutes following administration of study drug
Insulin Tmax
The time to maximum measured insulin concentrations.
Measured: Up to 360 minutes following administration of study drug
Insulin Area Under the Concentration (AUC) Curve
The insulin area under the concentration time curve after study drug administration.
Measured: Up to 360 minutes following administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start22 Aug 2019
- Primary completion2 Apr 2020
- Study completion2 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xeris Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Valasquez, Study director, Worldwide Clinical TrialsGeorge Atiee, Principal investigator, Worldwide Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074317
- Sponsor's protocol ID
- DPI-201
- Status last verified
- Feb 2024
- First submitted
- 28 Aug 2019
- Last updated
- 27 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Dose, Randomized, Open-Label, Active-Controlled, Crossover, Pharmacodynamic, and Pharmacokinetic Comparative Study of a Novel Pramlintide-Insulin Co-Formulation in Adults With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04074317
- Acronym / sponsor ID
- DPI-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Xeris PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Posted 27 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, active-controlled, single-dose, 3-treatment, 3-period, 3-way crossover, comparative PD and PK inpatient study in adults with T1D. The study comprises 5 visits: Screening (Visit 1), Treatment Periods (Visits 2 - 4), and Follow-Up (Visit 5).
Detailed description
The primary objective of this study is to evaluate the PD properties of a single dose of PRAM9 compared to single doses of regular insulin and regular insulin plus pramlintide (co-administered as separate injections) in adults with T1D. The secondary objectives of this study are to evaluate the safety and PK profiles of a single dose of PRAM9 compared to single doses of regular insulin and regular insulin plus pramlintide (co-administered as separate injections) in adults with T1D. During each treatment period subjects will receive a single SC dose of PRAM9, regular insulin, or co-administered regular insulin plus pramlintide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PRAM9 to Regular Insulin to Regular Insulin+pramlintide | Experimental | Drug: PRAM9, Drug: Regular Insulin + Pramlintide, Drug: Regular InsulinXeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin (Humulin®) to Regular Insulin+pramlintide (Symlin® pen) as separate SC injections |
| Regular Insulin to Regular Insulin+pramlintide to PRAM9 | Experimental | Drug: PRAM9, Drug: Regular Insulin + Pramlintide, Drug: Regular InsulinRegular Insulin (Humulin®) to Regular Insulin+pamlintide (Symlin® pen) as separate SC injections to PRAM9 |
| Regular Insulin+pramlintide to PRAM9 to Regular Insulin | Experimental | Drug: PRAM9, Drug: Regular Insulin + Pramlintide, Drug: Regular InsulinRegular Insulin (Humulin®)+pramlintide (Symlin® pen) as separate SC injections to Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin |
| PRAM9 to Regular Insulin+pramlintide to Regular Insulin | Experimental | Drug: PRAM9, Drug: Regular Insulin + Pramlintide, Drug: Regular InsulinXeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin (Humulin®)+pramlintide (Symlin® pen) as separate SC injections to Regular Insulin |
| Regular Insulin to PRAM9 to Regular Insulin+pramlintide | Experimental | Drug: PRAM9, Drug: Regular Insulin + Pramlintide, Drug: Regular InsulinRegular Insulin (Humulin®) to Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin+pramlintide (Symlin® pen) as separate SC injections to Regular Insulin |
| Regular Insulin+pramlintide to Regular Insulin to PRAM9 | Experimental | Drug: PRAM9, Drug: Regular Insulin + Pramlintide, Drug: Regular InsulinRegular Insulin (Humulin®)+pramlintide (Symlin® pen) as separate SC injections to Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin to Xeris pramlintide + insulin co-formulation (PRAM9) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Understands the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent
- Male or non-pregnant, non-lactating female diagnosed with T1D for at least 24 months prior to Screening.
- Aged 18 to 64 years of age, inclusive
- On a stable insulin regimen for 21 days prior to Screening (no greater than ± 20% variability in total daily dose)
- Have a plasma C-peptide level < 0.6 ng/mL at Screening
Key exclusion criteria (24 listed)
- Currently being treated with pramlintide or has discontinued pramlintide within 21 days of Screening
- Currently using an insulin pump
- Has renal insufficiency (serum creatinine <3.0 mg/dL) or end-stage renal disease requiring renal replacement therapy
- Has hepatic disease, including serum ALT or AST ≥3 times the upper limit of normal (ULN)
- Has hepatic synthetic insufficiency (serum albumin <3.0 g/dL)
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 |
|---|---|---|
| PRAM9SC injection | Drug | PRAM9 to Regular Insulin to Regular Insulin+pramlintide, PRAM9 to Regular Insulin+pramlintide to Regular Insulin, Regular Insulin to PRAM9 to Regular Insulin+pramlintide, Regular Insulin to Regular Insulin+pramlintide to PRAM9, Regular Insulin+pramlintide to PRAM9 to Regular Insulin, Regular Insulin+pramlintide to Regular Insulin to PRAM9 |
| Regular Insulin + PramlintideSeparate SC injections | Drug | PRAM9 to Regular Insulin to Regular Insulin+pramlintide, PRAM9 to Regular Insulin+pramlintide to Regular Insulin, Regular Insulin to PRAM9 to Regular Insulin+pramlintide, Regular Insulin to Regular Insulin+pramlintide to PRAM9, Regular Insulin+pramlintide to PRAM9 to Regular Insulin, Regular Insulin+pramlintide to Regular Insulin to PRAM9 |
| Regular InsulinSC injection | Drug | PRAM9 to Regular Insulin to Regular Insulin+pramlintide, PRAM9 to Regular Insulin+pramlintide to Regular Insulin, Regular Insulin to PRAM9 to Regular Insulin+pramlintide, Regular Insulin to Regular Insulin+pramlintide to PRAM9, Regular Insulin+pramlintide to PRAM9 to Regular Insulin, Regular Insulin+pramlintide to Regular Insulin to PRAM9 |
Primary outcome
Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL
Time frame: 0-180 minutes following administration of study drug
The PD effects on plasma glucose levels were compared among the treatment arms as defined by AUC0-180 (mg/dL * minutes) for plasma glucose >180 mg/dL
12 secondary outcomes
Mean Proportional Time for Plasma Glucose Levels
Time frame: Up to 360 minutes following administration of study drug
Mean Proportional Time After Glucose Challenge for Plasma Glucose Levels Between 126 to 180 mg/dL
Time frame: During 40 to 180 minutes post-injection of study drug
Area Under the Concentration (AUC) Curve for Plasma Glucose
Time frame: Up to 360 minutes following administration of study drug
Area Over the Concentration (AOC) Curve for Plasma Glucose
Time frame: Up to 360 minutes following administration of study drug
Plasma Glucose Cmax
Time frame: Up to 360 minutes following administration of study drug
Plasma Glucose Tmax
Time frame: Up to 360 minutes following administration of study drug
Pramlintide Cmax
Time frame: Up to 360 minutes following administration of study drug
Pramlintide Tmax
Time frame: Up to 360 minutes following administration of study drug
Pramlintide Area Under the Concentration (AUC) Curve
Time frame: Up to 360 minutes following administration of study drug
Insulin Cmax
Time frame: Up to 360 minutes following administration of study drug
Insulin Tmax
Time frame: Up to 360 minutes following administration of study drug
Insulin Area Under the Concentration (AUC) Curve
Time frame: Up to 360 minutes following administration of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Andrea Valasquez study director
Worldwide Clinical Trials
George Atiee principal investigator
Worldwide Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRAM9, Regular Insulin + Pramlintide and Regular Insulin in people with Diabetes Mellitus, Type 1 and Insulin-dependent Diabetes Mellitus, run by Xeris Pharmaceuticals at 1 site 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 9 inclusion and 24 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 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL (time frame: 0-180 minutes following administration of study drug). 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 27 Mar 2024.