NCT04623086

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Insulin degludec (IDeg), an ultra-long-acting basal insulin, is increasingly used to treat patients with type 1 diabetes (T1D). IDeg has a half-life of 25 hours and duration of action exceeding 42 hours in patients with T1D and as a result does not require as stringent a dosing schedule as other basal insulins. However, steady state concentration of IDeg is not reached until 2 to 3 doses are administered daily, and this may result in greater glycemic variability in the 24 to 72 hours following the initiation of therapy with IDeg. Our hypothesis is that among patients who transition from insulin glargine to IDeg, those who use a bridging dose of insulin glargine will not have a significant change, on average, in time spent in target glycemic range during the transition period, whereas, those transitioning directly to IDeg will have a significant change in this parameter. We further hypothesize that those using the bridging dose of insulin glargine will have less hypoglycemia, less hyperglycemia and need fewer correction boluses than the direct-conversion patients during the transition period. Though IDeg is being increasingly used in clinical practice, there are no guidelines on what is the best way to transition patients from other long-acting insulins, such as glargine, to IDeg. The package insert recommends 1:1 dose conversion from other basal insulins to IDeg, but this does not account for the time taken by IDeg to achieve steady state (typically 48-72 hours). There is no guidance on what to do in those 48-72 hours. Given the time taken for IDeg to achieve steady state, the period of transition from one insulin to another, can result in significant glycemic variation in the 24-72 hours after the first dose. We want to study how best to avoid or minimize this and the option of using a small dose of their original long-acting insulin has anecdotal evidence of success in our practice.

Conditions

• Type 1 Diabetes

Interventions

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

Timeline

• Start date: 2020-02-14
• Primary completion: 2022-09-07
• Completion: 2023-12-31
• First posted: 2020-11-10
• Last updated: 2024-02-28
• Results posted: 2024-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study