At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
PRAM9 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating PRAM9, Regular Insulin + Pramlintide, and 1 other intervention for Diabetes Mellitus, Type 1 and Insulin-dependent Diabetes Mellitus. Completed, enrolled 18 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
Enrollment StartAug 2019
First PostedAug 2019
Primary CompletionApr 2020
TodayJul 2026
First PostedAug 30, 2019
Enrollment StartAug 22, 2019
Primary CompletionApr 2, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.8 years ago
Interventions
PRAM9drug
SC injection
Regular Insulin + Pramlintidedrug
Separate SC injections
Regular Insulindrug
SC injection