CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 113 enrolled
Drug / intervention
verapamil 120mg tablet +3 moredrug
Likely dose
verapamil 120mg tabletfrom 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/NCT04233034
NCT04233034Phase 3Completed
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Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer)

Jaeb Center for Health Research·interventional·Posted Jan 18, 2020·Updated Nov 27, 2024

In Brief

A Phase 3 clinical trial evaluating HCL, verapamil 120mg tablet, and 2 other interventions for Type1 Diabetes. Completed, enrolled 113 participants across 6 sites.

Detailed Summary

Randomized trial of youth aged 7-\<18 years with newly diagnosed stage 3 type 1 diabetes (T1D) to assess the effect of both (1) near-normalization of glucose concentrations achieved through use of a hybrid closed loop (HCL) system and (2) verapamil on preservation of β-cell function 12 months after diagnosis. Participants with body weight ≥30 kg (Cohort A) will be randomly assigned in a factorial design to (1) HCL plus intensive diabetes management or usual care with no HCL and (2) verapamil or placebo. Participants with body weight \<30 kg (Cohort B) will be randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes management or to usual care with no HCL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType1 Diabetes
CountriesUnited States
CollaboratorsJuvenile Diabetes Research Foundation, University of Minnesota, DexCom, Inc., Medtronic, Tandem Diabetes Care, Inc.

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJan 18, 2020
Enrollment StartJul 9, 2020
Primary CompletionSep 15, 2022
Study CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 6.5 years ago

Interventions

HCLdevice

Hybrid Closed Loop therapy

verapamil 120mg tabletdrug

verapamil tablet

non-HCLdevice

Usual diabetes care

placebodrug

placebo pill manufactured to mimic verapamil 120mg tablet