NCT04074317

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2020

Completed
4 years until next milestone

Results Posted

Study results publicly available

March 27, 2024

Completed
Last Updated

March 27, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

August 28, 2019

Results QC Date

January 7, 2024

Last Update Submit

February 29, 2024

Conditions

Diabetes Mellitus, Type 1Insulin-dependent Diabetes Mellitus

Outcome Measures

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

    0-180 minutes following administration of study drug

Secondary Outcomes (12)

  • Mean Proportional Time for Plasma Glucose Levels

    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

    During 40 to 180 minutes post-injection of study drug

  • Area Under the Concentration (AUC) Curve for Plasma Glucose

    Up to 360 minutes following administration of study drug

  • Area Over the Concentration (AOC) Curve for Plasma Glucose

    Up to 360 minutes following administration of study drug

  • Plasma Glucose Cmax

    Up to 360 minutes following administration of study drug

  • +7 more secondary outcomes

Study Arms (6)

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

Drug: PRAM9Drug: Regular Insulin + PramlintideDrug: 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

Drug: PRAM9Drug: Regular Insulin + PramlintideDrug: 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

Drug: PRAM9Drug: Regular Insulin + PramlintideDrug: 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

Drug: PRAM9Drug: Regular Insulin + PramlintideDrug: 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

Drug: PRAM9Drug: Regular Insulin + PramlintideDrug: 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)

Drug: PRAM9Drug: Regular Insulin + PramlintideDrug: Regular Insulin

Interventions

PRAM9DRUG

SC injection

PRAM9 to Regular Insulin to Regular Insulin+pramlintidePRAM9 to Regular Insulin+pramlintide to Regular InsulinRegular Insulin to PRAM9 to Regular Insulin+pramlintideRegular Insulin to Regular Insulin+pramlintide to PRAM9Regular Insulin+pramlintide to PRAM9 to Regular InsulinRegular Insulin+pramlintide to Regular Insulin to PRAM9
Regular Insulin + PramlintideDRUG

Separate SC injections

PRAM9 to Regular Insulin to Regular Insulin+pramlintidePRAM9 to Regular Insulin+pramlintide to Regular InsulinRegular Insulin to PRAM9 to Regular Insulin+pramlintideRegular Insulin to Regular Insulin+pramlintide to PRAM9Regular Insulin+pramlintide to PRAM9 to Regular InsulinRegular Insulin+pramlintide to Regular Insulin to PRAM9
Regular InsulinDRUG

SC injection

PRAM9 to Regular Insulin to Regular Insulin+pramlintidePRAM9 to Regular Insulin+pramlintide to Regular InsulinRegular Insulin to PRAM9 to Regular Insulin+pramlintideRegular Insulin to Regular Insulin+pramlintide to PRAM9Regular Insulin+pramlintide to PRAM9 to Regular InsulinRegular Insulin+pramlintide to Regular Insulin to PRAM9

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

World Wide Clinical Trials

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulinpramlintide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Dawn Harper, VP Clinical Devlopment
Organization
Xeris Pharmaceuticals Inc.
dharper@xerispharma.com
(215) 704-7290

Study Officials

  • Andrea Valasquez

    Worldwide Clinical Trials

    STUDY DIRECTOR

  • George Atiee

    Worldwide Clinical Trials

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2019

First Posted

August 30, 2019

Study Start

August 22, 2019

Primary Completion

April 2, 2020

Study Completion

April 2, 2020

Last Updated

March 27, 2024

Results First Posted

March 27, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)