Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT04623086
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Insulin Degludec — DRUG
    Insulin Degludec injection
  • Insulin Glargine — DRUG
    Insulin Glargine injection
  • Placebo — DRUG
    9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection

Study Details

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.

Key Dates

Start date
Feb 14, 2020
Status verified
Feb 2024
Primary completion
Sep 7, 2022
Completion
Dec 31, 2023

Study Design

Enrollment
59 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Insulin Glargine and Insulin Degludec
    Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily
  • Placebo Comparator: Insulin Degludec and placebo
    Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily

Primary Outcome Measure

Mean Change in Percent Time in Range [ Time Frame: 48 hours prior to 48 hours after 1st dose of degludec insulin ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington Medicine Diabetes Institute at South Lake UnionSeattleWashington98109-

Find similar trials in Seattle, WA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Washington Medicine Diabetes Institute at South Lake Union· Seattle, WA

Related Studies