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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04074317
Recruitment Status : Completed
First Posted : August 30, 2019
Last Update Posted : May 28, 2020
Information provided by (Responsible Party):
Xeris Pharmaceuticals

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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Insulin-dependent Diabetes Mellitus Drug: PRAM9 Drug: Regular Insulin + Pramlintide Drug: Regular Insulin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 22, 2019
Actual Primary Completion Date : April 2, 2020
Actual Study Completion Date : April 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: PRAM9
Xeris pramlintide + insulin co-formulation
Drug: PRAM9
SC injection

Drug: Regular Insulin + Pramlintide
Separate SC injections

Drug: Regular Insulin
SC injection

Experimental: Regular Insulin + Pramlintide
Humulin® + Symlin® pen as separate injections
Drug: PRAM9
SC injection

Drug: Regular Insulin + Pramlintide
Separate SC injections

Drug: Regular Insulin
SC injection

Active Comparator: Regular Insulin
Drug: PRAM9
SC injection

Drug: Regular Insulin + Pramlintide
Separate SC injections

Drug: Regular Insulin
SC injection

Primary Outcome Measures :
  1. Area under the curve 0-180 minutes [ Time Frame: 0-180 minutes following administration of study drug ]

Secondary Outcome Measures :
  1. Glucose time above 180 mg/dL [ Time Frame: 0-180 minutes following administration of study drug ]
  2. Glucose time in range [ Time Frame: 0-180 minutes following administration of study drug ]
  3. Plasma glucose maximum concentration (Cmax) [ Time Frame: 0-180 minutes following administration of study drug ]
  4. Plasma glucose time to maximum concentration (Tmax) [ Time Frame: 0-180 minutes following administration of study drug ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Understands the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent
  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 HbA1c < 10% at Screening
  7. Body mass index (BMI) in the range of ≥ 18 to ≤ 35 kg/m2 at Screening
  8. 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.
  9. Fasting Serum triglyceride concentration < 200 mg/dL

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 ALT or AST ≥ 3 times the upper limit of normal (ULN)
  5. Has hepatic synthetic insufficiency (serum albumin < 3.0 g/dL) Has hematocrit ≤ 30%
  6. Has hematocrit ≤ 30%
  7. 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)
  8. Has clinically significant ECG abnormalities at Screening
  9. Has congestive heart failure, NYHA Class III or IV
  10. Has history of myocardial infarction, unstable angina, or revascularization within 6 months prior to Screening
  11. Has history of a cerebrovascular accident in 6 months prior to Screening with major neurological deficits
  12. Has active malignancy within 5 years prior to Screening (exception: basal cell or squamous cell skin cancers)
  13. Has had major surgical operation within 60 days prior to Screening or planned surgical operation during the study
  14. Has a seizure disorder (other than with suspected or documented hypoglycemia)
  15. Has a current bleeding disorder, treatment with anticoagulants, or platelet count < 50 ×109/L
  16. 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
  17. Has a history of positive test result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
  18. Has a concurrent illness not controlled by a stable therapeutic regimen
  19. 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.
  20. Has active substance or alcohol abuse (> 21 drinks/week for males or > 14 drinks/week for females)
  21. 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
  22. There is any reason the investigator deems exclusionary
  23. Has donated blood within 8 weeks prior to Screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04074317

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United States, Texas
World Wide Clinical Trials
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Xeris Pharmaceuticals
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Study Director: Andrea Valasquez Worldwide Clinical Trials
Principal Investigator: George Atiee Worldwide Clinical Trials
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Responsible Party: Xeris Pharmaceuticals Identifier: NCT04074317    
Other Study ID Numbers: DPI-201
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs