At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 59 enrolled
Drug / intervention
Insulin Degludec +2 moredrug
Likely dose
Placebo 9gfrom 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 Randomized Comparison of Transitioning From Insulin GLargine to Insulin Degludec usING a Bridging Dose of Glargine Versus Direct Conversion, in Patients With Type 1 Diabetes Mellitus - a Pilot Study
In Brief
A Phase 4 clinical trial evaluating Insulin Degludec, Insulin Glargine, and 1 other intervention for Type 1 Diabetes. Completed, enrolled 59 participants across 1 site.
Detailed Summary
This study evaluates direct switching vs use of a bridging dose from insulin glargine to insulin degludec in type 1 DM patients. Half of the participants will receive a bridging insulin glargine dose along with the 1st dose of degludec, while other half will receive a placebo and 1st dose of degludec.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2020202120222023202420252026
Enrollment StartFeb 2020
First PostedNov 2020
Primary CompletionSep 2022
Study CompletionDec 2023
TodayJul 2026
First PostedNov 10, 2020
Enrollment StartFeb 14, 2020
Primary CompletionSep 7, 2022
Study CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 5.6 years ago
Interventions
Insulin Degludecdrug
Insulin Degludec injection
Insulin Glarginedrug
Insulin Glargine injection
Placebodrug
9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection