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CompletedPhase 2Results posted

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

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

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

1

Recruiting sites

Enrollment

18

actual

Study population

Type 1 diabetes

Key I/E criteria

BMI 18-35HbA1c ≤10%

Primary endpoint

Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04074317
Org study IDDPI-201

Timeline

Milestones

Study start2019-08-22actual
Study first posted2019-08-30actual
Primary completion2020-04-02actual
Study completion2020-04-02actual
Last update posted2024-03-27actual
Results first posted2024-03-27actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersNot accepted

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)

6. Has a hematocrit value that is exclusionary: Female <35.5% and Male <38.3%

7. Has a hemoglobin 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 clinically significant ECG abnormalities at Screening

10. Has congestive heart failure, NYHA 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 malignancy 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 platelet count <50 ×10^9/L

17. 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

18. Has a history of positive test result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (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.

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
8
Safety / tolerability / PK
5

Glycemic / diabetes

8 endpoints
Primary/protocol endpoint

Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL

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

concentration, improvement

Posted result

GroupValue (mean), min*mg/dL95% CI
PRAM95019.6
Regular Insulin + Pramlintide4591.9
Regular Insulin13317.5
p<0.0001ANOVA
p0.694ANOVA
p<0.0001ANOVA
Secondary/protocol endpoint/low confidence

Mean Proportional Time for Plasma Glucose Levels

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

descriptive, improvement

Posted result

GroupValue (mean), percentage of time95% CI
PRAM9>180 mg/dL: 0 to 90 minutes5.6
>180 mg/dL: 0 to 180 minutes33.3
>180 mg/dL: 0 to 360 minutes45.8
>250 mg/dL: 0 to 180 minutes19.7
>250 mg/dL: 0 to 360 minutes27.1
<54 mg/dL: 0 to 90 minutes14.8
<54 mg/dL: 0 to 180 minutes7.4
<54 mg/dL: 0 to 360 minutes3.7
<70 mg/dL: 0 to 90 minutes46.7
<70 mg/dL: 0 to 180 minutes30.0
<70 mg/dL: 0 to 360 minutes15.0
Regular Insulin + Pramlintide>180 mg/dL: 0 to 90 minutes0.0
>180 mg/dL: 0 to 180 minutes31.3
>180 mg/dL: 0 to 360 minutes45.1
>250 mg/dL: 0 to 180 minutes18.0
>250 mg/dL: 0 to 360 minutes28.6
<54 mg/dL: 0 to 90 minutes19.4
<54 mg/dL: 0 to 180 minutes9.7
<54 mg/dL: 0 to 360 minutes43.1
<70 mg/dL: 0 to 90 minutes41.3
<70 mg/dL: 0 to 180 minutes20.6
<70 mg/dL: 0 to 360 minutes28.1
Regular Insulin>180 mg/dL: 0 to 90 minutes17.6
>180 mg/dL: 0 to 180 minutes58.7
>180 mg/dL: 0 to 360 minutes50.8
>250 mg/dL: 0 to 180 minutes40.3
>250 mg/dL: 0 to 360 minutes33.3
<54 mg/dL: 0 to 90 minutes0
<54 mg/dL: 0 to 180 minutes0
<54 mg/dL: 0 to 360 minutes52.1
<70 mg/dL: 0 to 90 minutes19.4
<70 mg/dL: 0 to 180 minutes22.2
<70 mg/dL: 0 to 360 minutes52.3
LS Mean Difference-21.2995% CI-41.23-1.36p0.041ANOVA

Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes

LS Mean Difference-7.4595% CI-31.4316.54p0.453ANOVA

Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes

LS Mean Difference13.8595% CI-8.4636.15p0.161ANOVA

Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes

LS Mean Difference-23.9395% CI-35.37-12.48p<0.001ANOVA

Plasma Glucose \>180 mg/dL: 0 to 180 minutes

LS Mean Difference3.1095% CI-7.8014.00p0.564ANOVA

Plasma Glucose \>180 mg/dL: 0 to 180 minutes

LS Mean Difference27.0395% CI15.9638.09p<0.001ANOVA

Plasma Glucose \>180 mg/dL: 0 to 180 minutes

LS Mean Difference-1.7495% CI-16.7013.22p0.813ANOVA

Plasma Glucose \>180 mg/dL: 0 to 360 minutes

LS Mean Difference2.3595% CI-11.4716.17p0.730ANOVA

Plasma Glucose \>180 mg/dL: 0 to 360 minutes

LS Mean Difference4.0995% CI-10.9719.15p0.582ANOVA

Plasma Glucose \>180 mg/dL: 0 to 360 minutes

Secondary/protocol endpoint

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

descriptive, improvement

Posted result

GroupValue (mean), percentage of time95% CI
PRAM911.0
Regular Insulin + Pramlintide10.7
Regular Insulin9.8
Secondary/protocol endpoint/low confidence

Area Under the Concentration (AUC) Curve for Plasma Glucose

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

descriptive, improvement

Posted result

GroupValue (mean), min*mg/dL95% CI
PRAM9AUC 0-90: >180 mg/dL475.0
AUC 0-180: >180 mg/dL5019.6
AUC 0-360: >180 mg/dL16255.8
AUC 0-180: >250 mg/dL1592.7
AUC 0-360: >250 mg/dL6506.3
Regular Insulin + PramlintideAUC 0-90: >180 mg/dL0
AUC 0-180: >180 mg/dL4591.9
AUC 0-360: >180 mg/dL16101.2
AUC 0-180: >250 mg/dL1455.0
AUC 0-360: >250 mg/dL6847.5
Regular InsulinAUC 0-90: >180 mg/dL1108.3
AUC 0-180: >180 mg/dL13317.5
AUC 0-360: >180 mg/dL22334.6
AUC 0-180: >250 mg/dL6302.5
AUC 0-360: >250 mg/dL16572.5
Secondary/protocol endpoint

Area Over the Concentration (AOC) Curve for Plasma Glucose

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

descriptive, improvement

Posted result

GroupValue (mean), min*mg/dL95% CI
PRAM9AUC 0-90: <54 mg/dL658.3
AOC 0-180: <54 mg/dL658.3
AOC 0-360: <54 mg/dL658.3
AOC 0-90: <70 mg/dL2565.0
AOC 0-180: <70 mg/dL3243.0
AOC 0-360: <70 mg/dL3243.0
Regular Insulin + PramlintideAUC 0-90: <54 mg/dL677.5
AOC 0-180: <54 mg/dL677.5
AOC 0-360: <54 mg/dL3545.0
AOC 0-90: <70 mg/dL2086.4
AOC 0-180: <70 mg/dL2086.4
AOC 0-360: <70 mg/dL3797.5
Regular InsulinAUC 0-90: <54 mg/dL0.0
AOC 0-180: <54 mg/dL0
AOC 0-360: <54 mg/dL7531.3
AOC 0-90: <70 mg/dL1010.0
AOC 0-180: <70 mg/dL1874.0
AOC 0-360: <70 mg/dL8242.5
Secondary/protocol endpoint

Plasma Glucose Cmax

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

concentration, descriptive

Posted result

GroupValue (mean), mg/dL95% CI
PRAM9301.4
Regular Insulin + Pramlintide303.3
Regular Insulin339.9
Secondary/protocol endpoint/low confidence

Plasma Glucose Tmax

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

descriptive

Posted result

GroupValue (mean), minutes95% CI
PRAM9251.7
Regular Insulin + Pramlintide208.3
Regular Insulin150.0
Secondary/protocol endpoint

Insulin Area Under the Concentration (AUC) Curve

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

concentration, descriptive

Posted result

GroupValue (mean), min*pg/mL95% CI
PRAM9AUC 0-904332.201
AUC 0-18090807.346
AUC 0-360150580.775
Regular Insulin + PramlintideAUC 0-9052936.566
AUC 0-180114109.946
AUC 0-360182852.584
Regular InsulinAUC 0-9059727.578
AUC 0-180143606.541
AUC 0-360269913.163
Ratio of geometric least-squares means53.1690% CI43.5964.83p<0.0001ANOVA
Ratio of geometric least-squares means65.2490% CI54.0278.80p0.0018ANOVA
Ratio of geometric least-squares means122.7390% CI101.33148.66p0.2391ANOVA
Ratio of geometric least-squares means54.2090% CI47.5861.73p<0.0001ANOVA
Ratio of geometric least-squares means71.2990% CI62.9980.69p0.0002ANOVA
Ratio of geometric least-squares means131.5590% CI116.01149.17p0.0026ANOVA
Ratio of geometric least-squares means51.3490% CI46.7456.39p<0.0001ANOVA
Ratio of geometric least-squares means78.2490% CI71.3985.76p0.0003ANOVA
Ratio of geometric least-squares means152.4190% CI138.91167.22p<0.0001ANOVA

Safety / tolerability / PK

5 endpoints
Secondary/protocol endpoint

Pramlintide Cmax

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

Cmax

concentration, descriptive

Posted result

GroupValue (mean), pg/mL95% CI
PRAM999.22
Regular Insulin + Pramlintide278.37
Ratio of geometric least-squares means37.0490% CI31.3643.75p<0.0001ANOVA

The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.

Secondary/protocol endpoint

Pramlintide Tmax

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

Tmax

descriptive

Posted result

GroupValue (median), minutes95% CI
PRAM940.521 – 150
Regular Insulin + Pramlintide10.010 – 24
Ratio of least-square means435.96p<0.0001ANOVA

The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.

Secondary/protocol endpoint

Pramlintide Area Under the Concentration (AUC) Curve

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

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (mean), min*pg/mL95% CI
PRAM9AUC 0-905752.239
AUC 0-1809021.278
AUC 0-3609491.208
Regular Insulin + PramlintideAUC 0-9010317.775
AUC 0-18011079.075
AUC 0-36011132.408
Ratio of geometric least-squares means60.4490% CI45.4180.43p0.0075ANOVA
Ratio of geometric least-squares means93.3290% CI70.14124.16p0.6773ANOVA
Ratio of geometric least-squares means97.4390% CI72.94130.14p0.8768ANOVA
Secondary/protocol endpoint

Insulin Cmax

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

Cmax

concentration, descriptive

Posted result

GroupValue (mean), pg/mL95% CI
PRAM9724.97
Regular Insulin + Pramlintide912.09
Regular Insulin1198.70
Ratio of geometric least-squares means53.8390% CI44.5165.11p<0.0001ANOVA

The statistical model was ana analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.

Ratio of geometric least-squares means73.1690% CI61.0687.67p0.0192ANOVA

The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.

Ratio of geometric least-squares means135.9190% CI113.10163.31p0.0244ANOVA

The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.

Secondary/protocol endpoint

Insulin Tmax

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

Tmax

concentration, descriptive

Posted result

GroupValue (median), minutes95% CI
PRAM9120.00 – 241
Regular Insulin + Pramlintide90.540 – 300
Regular Insulin121.030 – 360
Ratio of least-square means73.53p0.2541ANOVA

The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.

Ratio of least-squares means103.89p>0.9999ANOVA

The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.

Ratio of least-square means141.29p0.1747ANOVA

The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.