CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 400 target
Drug / intervention
pramlintide acetatedrug
Likely dose
pramlintide acetate 0.6 mgfrom 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/NCT00108004
NCT00108004Phase 3Completed
CompareCT.gov

A Phase 3B, Multicenter, Open-Label Study Investigating the Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Insulin Therapy

AstraZeneca·interventional·Posted Apr 13, 2005·Updated May 21, 2015

In Brief

A Phase 3 clinical trial evaluating pramlintide acetate for Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. Completed, enrolled 400 participants across 48 sites.

Detailed Summary

This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 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, Type 2 Diabetes Mellitus
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 13, 2005
Enrollment StartApr 1, 2003
Primary CompletionJun 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 21.2 years ago

Interventions

pramlintide acetatedrug

Pramlintide (0.6 mg/mL) in 5.0-mL multiple-draw glass vials for SC injection for 12weekes and after Pramlintide (1.0 mg/mL) 1.5 mL pen-cartridge. Subjects who do not switch to the pen-cartridge device at Week 12 will continue to administer pramlintide using a syringe and vial.