CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 34 enrolled
Drug / intervention
Pramlintide acetate +3 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.

Search/NCT02500979
NCT02500979Phase 1Completed
CompareCT.gov

A Randomized, Single-Blind, Two-Way Crossover, Placebo-Controlled Phase I Study to Compare the 24-hour Glucose Profile and Safety of Pramlintide and Insulin, Co-Administered in a Fixed-Dose Ratio, Versus Placebo and Insulin in Patients With Type 1 Diabetes Mellitus With Inadequate Glycemic Control

AstraZeneca·interventional·Posted Jul 17, 2015·Updated Nov 2, 2018

In Brief

A Phase 1 clinical trial evaluating Pramlintide acetate, Placebo, and 2 other interventions for Type 1 Diabetes Mellitus. Completed, enrolled 34 participants across 3 sites.

Detailed Summary

This study is designed to investigate the clinical efficacy and safety of pramlintide co-administered as a fixed-dose ratio with basal-bolus SC insulin, delivered simultaneously via 2 separate pumps, in subjects with type 1 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsJuvenile Diabetes Research Foundation

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 17, 2015
Enrollment StartAug 17, 2015
Primary CompletionAug 5, 2016
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 11.0 years ago

Interventions

Pramlintide acetatedrug

Pramlintide acetate administered by a separate pump

Placebodrug

Placebo administered by separate pump

Lispro insulin U-100drug

Subjects will be stabilized on a separate insulin pump and administered lispro insulin throughout the study, except during both inpatient treatment periods (Visit 4 and Visit 5)

Regular insulin U-100drug

Use during two in-patient treatment periods (visits 4 and 5) and administered by separate pump