Phase 2
Completed N=18
Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D
Diabetes Mellitus, Type 1 · Insulin-dependent Diabetes Mellitus
Source: ClinicalTrials.gov NCT04074317 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL — 5019.6; 4591.9; 13317.5 min*mg/dL — p=<0.0001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL |
5019.6; 4591.9; 13317.5 | <0.0001 sig |
| SECONDARY Mean Proportional Time for Plasma Glucose Levels |
5.6; 0.0; 17.6; 33.3; 31.3; 58.7 | 0.041 sig |
| SECONDARY Mean Proportional Time After Glucose Challenge for Plasma Glucose Levels Between 126 to 180 mg/dL |
11.0; 10.7; 9.8 | — |
| SECONDARY Area Under the Concentration (AUC) Curve for Plasma Glucose |
475.0; 0; 1108.3; 5019.6; 4591.9; 13317.5 | — |
| SECONDARY Area Over the Concentration (AOC) Curve for Plasma Glucose |
658.3; 677.5; 0.0; 658.3; 677.5; 0 | — |
| SECONDARY Plasma Glucose Cmax |
301.4; 303.3; 339.9 | — |
| SECONDARY Plasma Glucose Tmax |
251.7; 208.3; 150.0 | — |
| SECONDARY Pramlintide Cmax |
99.22; 278.37 | <0.0001 sig |
| SECONDARY Pramlintide Tmax |
40.5; 10.0 | <0.0001 sig |
| SECONDARY Pramlintide Area Under the Concentration (AUC) Curve |
5752.239; 10317.775; 9021.278; 11079.075; 9491.208; 11132.408 | 0.0075 sig |
| SECONDARY Insulin Cmax |
724.97; 912.09; 1198.70 | <0.0001 sig |
| SECONDARY Insulin Tmax |
120.0; 90.5; 121.0 | 0.2541 |
| SECONDARY Insulin Area Under the Concentration (AUC) Curve |
4332.201; 52936.566; 59727.578; 90807.346; 114109.946; 143606.541 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- 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 150 mm Hg or diastolic BP 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 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.
Data sourced from ClinicalTrials.gov (NCT04074317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.