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CompletedNCT04074317Updated Mar 27, 2024Results posted

Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D

A Phase 2 interventional study of PRAM9 and Regular Insulin + Pramlintide in Diabetes Mellitus, Type 1 and Insulin-dependent Diabetes Mellitus, sponsored by Xeris Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-03-27.

Sponsored by Xeris Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 51 studies testing insulin in Diabetes Mellitus, Type 1 — 4 open to participants now, 4 under way, none of them phase 3. Insulin · Diabetes Mellitus, Type 1.

Enrollment
30th of 51
18 · median 20
Started
2019
with 3 others
Phase 2
16 of 51
none open now
Registered
41st of 51
by date

Among the 51 studies testing insulin in Diabetes Mellitus, Type 1, this one is the 30th largest by enrollment, is one of 4 that started in 2019, is one of 16 in phase 2, and was the 41st registered.

By phase

51 studies; the count open now beside each. This study's row is marked.

Phase 2this study16 · 0 open
No phase11 · 0 open
Phase 410 · 3 open
Phase 37 · 0 open
Phase 14 · 1 open
Phase 1/22 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 1994; this study’s year is marked. 4 started in 2019.

Size and results

Median enrollment 20 across the 51 interventional studies. Of the 41 that completed or were terminated, 15 (37%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 51 studies testing insulin in Diabetes Mellitus, Type 1, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Diabetes Mellitus, Type 1
  • Insulin-dependent Diabetes Mellitus
04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Understands the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agrees to participate by giving written
  2. Male or non-pregnant, non-lactating female diagnosed with T1D for at least 24 months prior to Screening.
  3. Aged 18 to 64 years of age, inclusive
  4. On a stable insulin regimen for 21 days prior to Screening (no greater than ± 20% variability in total daily dose)
  5. Have a plasma C-peptide level \< 0.6 ng/mL at Screening
  6. Have an \< 10% at Screening
  7. (BMI) in the range of ≥ 18 to ≤ 35 kg/m2 at Screening
  8. For women of , there is a requirement for a negative urine pregnancy test at Screening and for agreement to use 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.
  9. Fasting Serum triglyceride concentration \< 200 mg/dL

Exclusion criteria

Exclusion Criteria:

  1. Currently being treated with pramlintide or has discontinued pramlintide within 21 days of Screening
  2. Currently using an insulin pump
  3. Has renal insufficiency (serum creatinine \<3.0 mg/dL) or end-stage renal disease requiring renal replacement therapy
  4. Has hepatic disease, including serum or AST ≥3 times the (ULN)
  5. Has hepatic synthetic insufficiency (serum albumin \<3.0 g/dL)
  6. Has a hematocrit value that is exclusionary: Female \<35.5% and Male \<38.3%
  7. Has a value that is exclusionary: Female \<11.5 g/dL and Male \<12.5 g/dL
  8. 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)
  9. Has abnormalities at Screening
  10. Has congestive heart failure, Class III or IV
  11. Has history of myocardial infarction, unstable angina, or revascularization within 6 months prior to Screening
  12. Has history of a cerebrovascular accident in 6 months prior to Screening with major neurological deficits
  13. Has active within 5 years prior to Screening (exception: basal cell or squamous cell skin cancers)
  14. Has had major surgical operation within 60 days prior to Screening or planned surgical operation during the study
  15. Has a seizure disorder (other than with suspected or documented hypoglycemia)
  16. Has a current bleeding disorder, treatment with anticoagulants, or count \<50 ×10\^9/L
  17. Has a history of allergies or significant to pramlintide or any pramlintide-related products or to any of the in the formulation
  18. Has a history of positive test result for virus (HBV), virus (HCV), or (HIV)
  19. Has a concurrent illness not controlled by a stable therapeutic regimen
  20. 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.
  21. Has active substance or alcohol abuse (>21 drinks/week for males or >14 drinks/week for females)
  22. 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
  23. There is any reason the investigator deems exclusionary
  24. Has donated blood within 8 weeks prior to Screening.
Terms in these criteria, in plain language(19)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    PRAM9 to Regular Insulin to Regular Insulin+pramlintide

    Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin (Humulin®) to Regular Insulin+pramlintide (Symlin® pen) as separate SC injections

    Drug: PRAM9 · Drug: Regular Insulin + Pramlintide · Drug: Regular Insulin

  • Experimental
    Regular Insulin to Regular Insulin+pramlintide to PRAM9

    Regular Insulin (Humulin®) to Regular Insulin+pamlintide (Symlin® pen) as separate SC injections to PRAM9

    Drug: PRAM9 · Drug: Regular Insulin + Pramlintide · Drug: Regular Insulin

  • Experimental
    Regular Insulin+pramlintide to PRAM9 to Regular Insulin

    Regular Insulin (Humulin®)+pramlintide (Symlin® pen) as separate SC injections to Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin

    Drug: PRAM9 · Drug: Regular Insulin + Pramlintide · Drug: Regular Insulin

  • Experimental
    PRAM9 to Regular Insulin+pramlintide to Regular Insulin

    Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin (Humulin®)+pramlintide (Symlin® pen) as separate SC injections to Regular Insulin

    Drug: PRAM9 · Drug: Regular Insulin + Pramlintide · Drug: Regular Insulin

  • Experimental
    Regular Insulin to PRAM9 to Regular Insulin+pramlintide

    Regular Insulin (Humulin®) to Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin+pramlintide (Symlin® pen) as separate SC injections to Regular Insulin

    Drug: PRAM9 · Drug: Regular Insulin + Pramlintide · Drug: Regular Insulin

  • Experimental
    Regular Insulin+pramlintide to Regular Insulin to PRAM9

    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)

    Drug: PRAM9 · Drug: Regular Insulin + Pramlintide · Drug: Regular Insulin

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 0-180 minutes following administration of study drug

Secondary outcomes

  1. 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

    Time frame: Up to 360 minutes following administration of study drug

  2. 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.

    Time frame: During 40 to 180 minutes post-injection of study drug

  3. 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

    Time frame: Up to 360 minutes following administration of study drug

  4. 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

    Time frame: Up to 360 minutes following administration of study drug

  5. Plasma Glucose Cmax

    The maximum measured glucose concentrations over the time span.

    Time frame: Up to 360 minutes following administration of study drug

  6. Plasma Glucose Tmax

    The time to maximum measured glucose concentrations.

    Time frame: Up to 360 minutes following administration of study drug

  7. Pramlintide Cmax

    The maximum measured pramlintide concentrations (arithmetic mean).

    Time frame: Up to 360 minutes following administration of study drug

  8. Pramlintide Tmax

    The time to maximum measured pramlintide concentrations.

    Time frame: Up to 360 minutes following administration of study drug

  9. Pramlintide Area Under the Concentration (AUC) Curve

    The pramlintide area under the concentration time curve after study drug administration (arithmetic mean).

    Time frame: Up to 360 minutes following administration of study drug

  10. Insulin Cmax

    The maximum measured insulin concentrations (arithmetic mean)

    Time frame: Up to 360 minutes following administration of study drug

  11. Insulin Tmax

    The time to maximum measured insulin concentrations.

    Time frame: Up to 360 minutes following administration of study drug

  12. Insulin Area Under the Concentration (AUC) Curve

    The insulin area under the concentration time curve after study drug administration.

    Time frame: Up to 360 minutes following administration of study drug

07

Results

Posted Mar 27, 2024

Participant flow

The study was a 3-treatment, 6-sequence, 3-period crossover design where 18 eligible subjects randomized to 6 treatment sequences (3 subjects per sequence), with each subject scheduled to receive all 3 treatments.

First Period
Participant flow — First Period
MilestonePRAM9 to Regular Insulin to Regular Insulin+PramlintideRegular Insulin to Regular Insulin+Pramlintide to PRAM9Regular Insulin+Pramlintide to PRAM9 to Regular InsulinPRAM9 to Regular Insulin+Pramlintide to Regular InsulinRegular Insulin to PRAM9 to Regular Insulin+PramlintideRegular Insulin+Pramlintide to Regular Insulin to PRAM9
Started333333
Completed333333
Not completed000000
Second Period
Participant flow — Second Period
MilestonePRAM9 to Regular Insulin to Regular Insulin+PramlintideRegular Insulin to Regular Insulin+Pramlintide to PRAM9Regular Insulin+Pramlintide to PRAM9 to Regular InsulinPRAM9 to Regular Insulin+Pramlintide to Regular InsulinRegular Insulin to PRAM9 to Regular Insulin+PramlintideRegular Insulin+Pramlintide to Regular Insulin to PRAM9
Started333333
Completed333333
Not completed000000
Third Period
Participant flow — Third Period
MilestonePRAM9 to Regular Insulin to Regular Insulin+PramlintideRegular Insulin to Regular Insulin+Pramlintide to PRAM9Regular Insulin+Pramlintide to PRAM9 to Regular InsulinPRAM9 to Regular Insulin+Pramlintide to Regular InsulinRegular Insulin to PRAM9 to Regular Insulin+PramlintideRegular Insulin+Pramlintide to Regular Insulin to PRAM9
Started333333
Completed333233
Not completed000100
Withdrew: Withdrawal by subject000100

Outcome measures

PrimaryArea 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

Time frame:
0-180 minutes following administration of study drug
Reported as:
Mean · min*mg/dL
Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL
min*mg/dLPRAM9Regular Insulin + PramlintideRegular Insulin
Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL5019.6 ± 4276.534591.9 ± 3095.5313317.5 ± 5262.42
Statistical analysis
  • PRAM9 vs Regular Insulin · ANOVA · p = <0.0001 (Least-squares geometric means for ln-transformed data.)
  • PRAM9 vs Regular Insulin + Pramlintide · ANOVA · p = 0.694
  • Regular Insulin + Pramlintide vs Regular Insulin · ANOVA · p = <0.0001
SecondaryMean 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

Time frame:
Up to 360 minutes following administration of study drug
Reported as:
Mean · percentage of time
Mean Proportional Time for Plasma Glucose Levels
percentage of timePRAM9Regular Insulin + PramlintideRegular Insulin
>180 mg/dL: 0 to 90 minutes5.6 ± 13.610.0 ± 0.0017.6 ± 16.72
>180 mg/dL: 0 to 180 minutes33.3 ± 19.6131.3 ± 13.4458.7 ± 14.57
>180 mg/dL: 0 to 360 minutes45.8 ± 24.7945.1 ± 23.2150.8 ± 18.25
>250 mg/dL: 0 to 180 minutes19.7 ± 17.9818.0 ± 15.9040.3 ± 15.01
>250 mg/dL: 0 to 360 minutes27.1 ± 21.4128.6 ± 19.8133.3 ± 16.67
<54 mg/dL: 0 to 90 minutes14.8 ± 16.9719.4 ± 24.640 ± 0
<54 mg/dL: 0 to 180 minutes7.4 ± 8.499.7 ± 12.320 ± 0
<54 mg/dL: 0 to 360 minutes3.7 ± 4.2543.1 ± 49.7252.1 ± 40.15
<70 mg/dL: 0 to 90 minutes46.7 ± 26.5341.3 ± 25.4319.4 ± 5.56
<70 mg/dL: 0 to 180 minutes30.0 ± 23.7620.6 ± 12.7222.2 ± 34.47
<70 mg/dL: 0 to 360 minutes15.0 ± 11.8828.1 ± 39.8852.3 ± 42.33
Statistical analysis
  • PRAM9 vs Regular Insulin · ANOVA · p = 0.041 · Ls mean difference: -21.29 · 95% CI -41.23 to -1.36
  • PRAM9 vs Regular Insulin + Pramlintide · ANOVA · p = 0.453 · Ls mean difference: -7.45 · 95% CI -31.43 to 16.54
  • Regular Insulin + Pramlintide vs Regular Insulin · ANOVA · p = 0.161 · Ls mean difference: 13.85 · 95% CI -8.46 to 36.15
  • PRAM9 vs Regular Insulin · ANOVA · p = <0.001 · Ls mean difference: -23.93 · 95% CI -35.37 to -12.48
  • PRAM9 vs Regular Insulin + Pramlintide · ANOVA · p = 0.564 · Ls mean difference: 3.10 · 95% CI -7.80 to 14.00
  • Regular Insulin + Pramlintide vs Regular Insulin · ANOVA · p = <0.001 · Ls mean difference: 27.03 · 95% CI 15.96 to 38.09
  • PRAM9 vs Regular Insulin · ANOVA · p = 0.813 · Ls mean difference: -1.74 · 95% CI -16.70 to 13.22
  • PRAM9 vs Regular Insulin + Pramlintide · ANOVA · p = 0.730 · Ls mean difference: 2.35 · 95% CI -11.47 to 16.17
  • Regular Insulin + Pramlintide vs Regular Insulin · ANOVA · p = 0.582 · Ls mean difference: 4.09 · 95% CI -10.97 to 19.15
SecondaryMean 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.

Time frame:
During 40 to 180 minutes post-injection of study drug
Reported as:
Mean · percentage of time
Mean Proportional Time After Glucose Challenge for Plasma Glucose Levels Between 126 to 180 mg/dL
percentage of timePRAM9Regular Insulin + PramlintideRegular Insulin
Mean Proportional Time After Glucose Challenge for Plasma Glucose Levels Between 126 to 180 mg/dL11.0 ± 11.4110.7 ± 19.389.8 ± 11.92
SecondaryArea 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

Time frame:
Up to 360 minutes following administration of study drug
Reported as:
Mean · min*mg/dL
Area Under the Concentration (AUC) Curve for Plasma Glucose
min*mg/dLPRAM9Regular Insulin + PramlintideRegular Insulin
AUC 0-90: >180 mg/dL475.0 ± 1163.510 ± 01108.3 ± 1193.57
AUC 0-180: >180 mg/dL5019.6 ± 4276.534591.9 ± 3095.5313317.5 ± 5262.42
AUC 0-360: >180 mg/dL16255.8 ± 13128.4616101.2 ± 11859.6822334.6 ± 13794.26
AUC 0-180: >250 mg/dL1592.7 ± 1813.871455.0 ± 1783.266302.5 ± 3495.22
AUC 0-360: >250 mg/dL6506.3 ± 8153.006847.5 ± 7282.2316572.5 ± 26676.00
SecondaryArea 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

Time frame:
Up to 360 minutes following administration of study drug
Reported as:
Mean · min*mg/dL
Area Over the Concentration (AOC) Curve for Plasma Glucose
min*mg/dLPRAM9Regular Insulin + PramlintideRegular Insulin
AUC 0-90: <54 mg/dL658.3 ± 753.40677.5 ± 890.360.0 ± 0.00
AOC 0-180: <54 mg/dL658.3 ± 753.40677.5 ± 890.360 ± 0
AOC 0-360: <54 mg/dL658.3 ± 753.403545.0 ± 6603.377531.3 ± 5681.44
AOC 0-90: <70 mg/dL2565.0 ± 1665.802086.4 ± 1355.661010.0 ± 337.27
AOC 0-180: <70 mg/dL3243.0 ± 2611.352086.4 ± 1355.661874.0 ± 2587.66
AOC 0-360: <70 mg/dL3243.0 ± 2611.353797.5 ± 6070.528242.5 ± 6016.84
SecondaryPlasma Glucose Cmax

The maximum measured glucose concentrations over the time span.

Time frame:
Up to 360 minutes following administration of study drug
Reported as:
Mean · mg/dL
Plasma Glucose Cmax
mg/dLPRAM9Regular Insulin + PramlintideRegular Insulin
Plasma Glucose Cmax301.4 ± 66.72303.3 ± 73.37339.9 ± 162.73
SecondaryPlasma Glucose Tmax

The time to maximum measured glucose concentrations.

Time frame:
Up to 360 minutes following administration of study drug
Reported as:
Mean · minutes
Plasma Glucose Tmax
minutesPRAM9Regular Insulin + PramlintideRegular Insulin
Plasma Glucose Tmax251.7 ± 83.68208.3 ± 47.68150.0 ± 49.75
SecondaryPramlintide Cmax

The maximum measured pramlintide concentrations (arithmetic mean).

Time frame:
Up to 360 minutes following administration of study drug
Reported as:
Mean · pg/mL
Pramlintide Cmax
pg/mLPRAM9Regular Insulin + PramlintideRegular Insulin
Pramlintide Cmax99.22 ± 41.403278.37 ± 148.512—
Statistical analysis
  • PRAM9 vs Regular Insulin + Pramlintide · ANOVA · p = <0.0001 (Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.) · Ratio of geometric least-squares means: 37.04 · 90% CI 31.36 to 43.75Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.
SecondaryPramlintide Tmax

The time to maximum measured pramlintide concentrations.

Time frame:
Up to 360 minutes following administration of study drug
Reported as:
Median · minutes
Pramlintide Tmax
minutesPRAM9Regular Insulin + PramlintideRegular Insulin
Pramlintide Tmax40.5 (21 to 150)10.0 (10 to 24)—
Statistical analysis
  • PRAM9 vs Regular Insulin + Pramlintide · ANOVA · p = <0.0001 (Results of the statistical evaluation of ANOVA (alpha = 0.05) for the hypothesis of equal treatment effects.) · Ratio of least-square means: 435.96Ratio calculated as PRAM least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.
SecondaryPramlintide Area Under the Concentration (AUC) Curve

The pramlintide area under the concentration time curve after study drug administration (arithmetic mean).

Time frame:
Up to 360 minutes following administration of study drug
Reported as:
Mean · min*pg/mL
Pramlintide Area Under the Concentration (AUC) Curve
min*pg/mLPRAM9Regular Insulin + PramlintideRegular Insulin
AUC 0-905752.239 ± 2964.034010317.775 ± 6782.4249—
AUC 0-1809021.278 ± 4669.085111079.075 ± 7836.2702—
AUC 0-3609491.208 ± 4974.949011132.408 ± 7948.9301—
Statistical analysis
  • PRAM9 vs Regular Insulin + Pramlintide · ANOVA · p = 0.0075 (Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.) · Ratio of geometric least-squares means: 60.44 · 90% CI 45.41 to 80.43Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.
  • PRAM9 vs Regular Insulin + Pramlintide · ANOVA · p = 0.6773 (Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.) · Ratio of geometric least-squares means: 93.32 · 90% CI 70.14 to 124.16Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.
  • PRAM9 vs Regular Insulin + Pramlintide · ANOVA · p = 0.8768 (Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.) · Ratio of geometric least-squares means: 97.43 · 90% CI 72.94 to 130.14Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.
SecondaryInsulin Cmax

The maximum measured insulin concentrations (arithmetic mean)

Time frame:
Up to 360 minutes following administration of study drug
Reported as:
Mean · pg/mL
Insulin Cmax
pg/mLPRAM9Regular Insulin + PramlintideRegular Insulin
Insulin Cmax724.97 ± 345.106912.09 ± 393.6861198.70 ± 439.528
Statistical analysis
  • PRAM9 vs Regular Insulin · ANOVA · p = <0.0001 (Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.) · Ratio of geometric least-squares means: 53.83 · 90% CI 44.51 to 65.11Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.
  • PRAM9 vs Regular Insulin + Pramlintide · ANOVA · p = 0.0192 (Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.) · Ratio of geometric least-squares means: 73.16 · 90% CI 61.06 to 87.67Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.
  • Regular Insulin + Pramlintide vs Regular Insulin · ANOVA · p = 0.0244 (Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.) · Ratio of geometric least-squares means: 135.91 · 90% CI 113.10 to 163.31Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.
SecondaryInsulin Tmax

The time to maximum measured insulin concentrations.

Time frame:
Up to 360 minutes following administration of study drug
Reported as:
Median · minutes
Insulin Tmax
minutesPRAM9Regular Insulin + PramlintideRegular Insulin
Insulin Tmax120.0 (0 to 241)90.5 (40 to 300)121.0 (30 to 360)
Statistical analysis
  • PRAM9 vs Regular Insulin · ANOVA · p = 0.2541 (Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05) · Ratio of least-square means: 73.53Ratio calculated as PRAM least-squares mean divided by the Regular Insulin least-squares mean, expressed as a percentage.
  • PRAM9 vs Regular Insulin + Pramlintide · ANOVA · p = >0.9999 (Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.) · Ratio of least-squares means: 103.89Ratio calculated as PRAM least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.
  • Regular Insulin + Pramlintide vs Regular Insulin · ANOVA · p = 0.1747 (Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.) · Ratio of least-square means: 141.29Ratio calculated as Regular Insulin least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.
SecondaryInsulin Area Under the Concentration (AUC) Curve

The insulin area under the concentration time curve after study drug administration.

Time frame:
Up to 360 minutes following administration of study drug
Reported as:
Mean · min*pg/mL
Insulin Area Under the Concentration (AUC) Curve
min*pg/mLPRAM9Regular Insulin + PramlintideRegular Insulin
AUC 0-904332.201 ± 27662.173352936.566 ± 25400.605459727.578 ± 26405.0845
AUC 0-18090807.346 ± 45238.6643114109.946 ± 49208.9630143606.541 ± 54329.1923
AUC 0-360150580.775 ± 73403.0839182852.584 ± 100930.8761269913.163 ± 100898.6768
Statistical analysis
  • PRAM9 vs Regular Insulin · ANOVA · p = <0.0001 (Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.) · Ratio of geometric least-squares means: 53.16 · 90% CI 43.59 to 64.83Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.
  • PRAM9 vs Regular Insulin + Pramlintide · ANOVA · p = 0.0018 (Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05) · Ratio of geometric least-squares means: 65.24 · 90% CI 54.02 to 78.80Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.
  • Regular Insulin + Pramlintide vs Regular Insulin · ANOVA · p = 0.2391 (Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05) · Ratio of geometric least-squares means: 122.73 · 90% CI 101.33 to 148.66Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.
  • PRAM9 vs Regular Insulin · ANOVA · p = <0.0001 (Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.) · Ratio of geometric least-squares means: 54.20 · 90% CI 47.58 to 61.73Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.
  • PRAM9 vs Regular Insulin + Pramlintide · ANOVA · p = 0.0002 (Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05) · Ratio of geometric least-squares means: 71.29 · 90% CI 62.99 to 80.69Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.
  • Regular Insulin + Pramlintide vs Regular Insulin · ANOVA · p = 0.0026 (Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.) · Ratio of geometric least-squares means: 131.55 · 90% CI 116.01 to 149.17Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.
  • PRAM9 vs Regular Insulin · ANOVA · p = <0.0001 (Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.) · Ratio of geometric least-squares means: 51.34 · 90% CI 46.74 to 56.39Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.
  • PRAM9 vs Regular Insulin + Pramlintide · ANOVA · p = 0.0003 (Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.) · Ratio of geometric least-squares means: 78.24 · 90% CI 71.39 to 85.76Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.
  • Regular Insulin + Pramlintide vs Regular Insulin · ANOVA · p = <0.0001 (Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.) · Ratio of geometric least-squares means: 152.41 · 90% CI 138.91 to 167.22Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage. Confidence interval on the ratio, expressed as a percentage.

Adverse events

Collected over AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PRAM90/18 (0%)0/18 (0%)10/18 (55.6%)
Regular Insulin + Pramlintide0/18 (0%)0/18 (0%)9/18 (50%)
Regular Insulin0/17 (0%)0/17 (0%)10/17 (58.8%)
Most frequent other events
Showing 10 of 13
Most frequent other events
EventPRAM9Regular Insulin + PramlintideRegular Insulin
HypoglycemiaMetabolism and nutrition disorders6/188/187/17
NauseaGastrointestinal disorders2/181/180/17
HeadacheNervous system disorders2/181/181/17
ThirstGeneral disorders0/180/181/17
Vessel puncture site thrombosisGeneral disorders0/180/181/17
Back painMusculoskeletal and connective tissue disorders0/180/181/17
DizzinessNervous system disorders0/181/181/17
AstheniaGeneral disorders1/180/180/17
Injection site bruisingGeneral disorders0/181/180/17
Injection site discomfortGeneral disorders1/181/180/17

Baseline characteristics

Baseline characteristics by enrollment arm.

Age, Categorical
Age, Categorical(Participants)PRAM9 to Regular Insulin to Regular Insulin+PramlintideRegular Insulin to Regular Insulin+Pramlintide to PRAM9Regular Insulin+Pramlintide to PRAM9 to Regular InsulinPRAM9 to Regular Insulin+Pramlintide to Regular InsulinRegular Insulin to PRAM9 to Regular Insulin+PramlintideRegular Insulin+Pramlintide to Regular Insulin to PRAM9Total
<=18 years0000000
Between 18 and 65 years33333318
>=65 years0000000
Age, Continuous
Age, Continuous(years)PRAM9 to Regular Insulin to Regular Insulin+PramlintideRegular Insulin to Regular Insulin+Pramlintide to PRAM9Regular Insulin+Pramlintide to PRAM9 to Regular InsulinPRAM9 to Regular Insulin+Pramlintide to Regular InsulinRegular Insulin to PRAM9 to Regular Insulin+PramlintideRegular Insulin+Pramlintide to Regular Insulin to PRAM9Total
Mean46.7 ± 21.3645.0 ± 18.6842.3 ± 14.5038.0 ± 5.5742.0 ± 9.5449.3 ± 4.7343.9 ± 12.27
Sex: Female, Male
Sex: Female, Male(Participants)PRAM9 to Regular Insulin to Regular Insulin+PramlintideRegular Insulin to Regular Insulin+Pramlintide to PRAM9Regular Insulin+Pramlintide to PRAM9 to Regular InsulinPRAM9 to Regular Insulin+Pramlintide to Regular InsulinRegular Insulin to PRAM9 to Regular Insulin+PramlintideRegular Insulin+Pramlintide to Regular Insulin to PRAM9Total
Female02232110
Male3110128
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PRAM9 to Regular Insulin to Regular Insulin+PramlintideRegular Insulin to Regular Insulin+Pramlintide to PRAM9Regular Insulin+Pramlintide to PRAM9 to Regular InsulinPRAM9 to Regular Insulin+Pramlintide to Regular InsulinRegular Insulin to PRAM9 to Regular Insulin+PramlintideRegular Insulin+Pramlintide to Regular Insulin to PRAM9Total
Hispanic or Latino0012216
Not Hispanic or Latino33211212
Unknown or Not Reported0000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PRAM9 to Regular Insulin to Regular Insulin+PramlintideRegular Insulin to Regular Insulin+Pramlintide to PRAM9Regular Insulin+Pramlintide to PRAM9 to Regular InsulinPRAM9 to Regular Insulin+Pramlintide to Regular InsulinRegular Insulin to PRAM9 to Regular Insulin+PramlintideRegular Insulin+Pramlintide to Regular Insulin to PRAM9Total
American Indian or Alaska Native0000000
Asian0000000
Native Hawaiian or Other Pacific Islander0000000
Black or African American1000001
White23333317
More than one race0000000
Unknown or Not Reported0000000
Region of Enrollment
Region of Enrollment(participants)PRAM9 to Regular Insulin to Regular Insulin+PramlintideRegular Insulin to Regular Insulin+Pramlintide to PRAM9Regular Insulin+Pramlintide to PRAM9 to Regular InsulinPRAM9 to Regular Insulin+Pramlintide to Regular InsulinRegular Insulin to PRAM9 to Regular Insulin+PramlintideRegular Insulin+Pramlintide to Regular Insulin to PRAM9Total
United States33333318
Weight
Weight(kg)PRAM9 to Regular Insulin to Regular Insulin+PramlintideRegular Insulin to Regular Insulin+Pramlintide to PRAM9Regular Insulin+Pramlintide to PRAM9 to Regular InsulinPRAM9 to Regular Insulin+Pramlintide to Regular InsulinRegular Insulin to PRAM9 to Regular Insulin+PramlintideRegular Insulin+Pramlintide to Regular Insulin to PRAM9Total
Mean81.30 ± 4.95272.23 ± 2.90283.43 ± 22.7462.27 ± 4.09976.20 ± 11.88880.53 ± 11.86975.99 ± 12.407
Height
Height(cm)PRAM9 to Regular Insulin to Regular Insulin+PramlintideRegular Insulin to Regular Insulin+Pramlintide to PRAM9Regular Insulin+Pramlintide to PRAM9 to Regular InsulinPRAM9 to Regular Insulin+Pramlintide to Regular InsulinRegular Insulin to PRAM9 to Regular Insulin+PramlintideRegular Insulin+Pramlintide to Regular Insulin to PRAM9Total
Mean175.43 ± 7.643173.20 ± 15.552170.47 ± 14.332160.17 ± 5.299169.17 ± 17.208175.00 ± 9.034170.57 ± 11.642

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • World Wide Clinical Trials
    San Antonio, Texas 78217, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2019 to primary completion in Apr 2020, 7 months.

Results were first posted in Mar 2024, 3 years 11 months after primary completion.

Of 50 industry-sponsored phase 2 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 33. This study's 7 months is below that.

Counting every sponsor, half of 133 studies reached it within 36 months; a quarter within 17 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2019
First posted
Aug 30, 2019
StartActual
Aug 22, 2019
Primary completionActual
Apr 2, 2020
CompletionActual
Apr 2, 2020
Results first posted
Mar 27, 2024
Last update
Mar 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04074317
Lead sponsor
Xeris Pharmaceuticals
Responsible party
Sponsor
First posted
Aug 30, 2019
Start date
Aug 22, 2019
Primary completion
Apr 2, 2020
Completion
Apr 2, 2020
Results posted
Mar 27, 2024
Last update
Mar 27, 2024

Study contacts

Andrea Valasquez
study director · Worldwide Clinical Trials
George Atiee
principal investigator · Worldwide Clinical Trials

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Insulin · Pramlintide

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