Back to resultsComparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose (GLIDING)
Primary Purpose
Type 1 Diabetes
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Insulin Degludec
Insulin Glargine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Insulin glargine, insulin degludec
Eligibility Criteria
Inclusion Criteria:
Patients must meet ALL inclusion criteria to be included in the study.
- Patient age is 18-75 years.
- Diagnosis of T1D of at least 1-year duration.
- Has the ability to provide informed consent before any trial-related activities.
- Treated with insulin glargine as their basal insulin in the 3 months preceding screening visit.
- Stable insulin regimen (defined as change of <20% in the total daily dose of insulin and no change to the basal insulin agent) over the 3 months preceding the screening visit.
- Patient willing to dose their basal insulin at bedtime.
- Hemoglobin A1c < 9% in the 3 months preceding screening visit.
- Able to self-administer their insulin doses.
- Able to do self-monitoring of blood glucose using a glucose meter and willing to do this at least 2 times daily for patients using a CGM that requires calibration prior to the study and 4 times daily for patients who were not using a CGM prior to the study.
- Agreeable to the use of a continuous glucose monitor (CGM) for the duration required in the study. If already using a CGM prior to the study, then agreeable to wearing the blinded study CGM concurrently during the study period.
- Will be reachable by phone and/or email to comply with study procedures.
- Will be able to comply with study procedures, per investigator's opinion.
- Patient agrees to not use correctional insulin unless BG ≥250 for the 48 hours before and after 1st dose of IDeg.
Exclusion Criteria:
Patient must not have ANY of the exclusion criteria to be included in the study.
- Patients with eGFR <30 on at least 2 measurements within 1-year of the screening visit.
- History of myocardial infarction within 6 months preceding the screening visit.
- Patients taking non-insulin medications for the glycemic management of T1D (including metformin, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 inhibitors, thiazolidinediones, alpha-glucosidase inhibitors, pramlintide)
- Known or suspected allergy to IDeg or one of its excipients.
- Pregnant, planning to become pregnant in the next 3 months or breastfeeding.
- Participation in a clinical trial with investigational drug within 1 month of the screening visit or at present.
- Skin condition that prevents the insertion of the CGM.
- Previously randomized and received drug in this study.
- Presence of decompensated or poorly controlled psychiatric conditions.
- Current known or suspected illicit substance use.
- Any anticipated surgery or procedure in the next 14 days.
- Patients using U-300 glargine as their basal insulin.
- Patients using insulin afrezza as their short-acting insulin.
- Use of glucocorticoid burst/pulse therapy within 14 days prior to screening visit (chronic stable glucocorticoid doses are acceptable).
Sites / Locations
- University of Washington Medicine Diabetes Institute at South Lake Union
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Insulin Glargine and Insulin Degludec
Insulin Degludec and placebo
Arm Description
Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily
Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily
Outcomes
Primary Outcome Measures
Mean change in percent time in range
Change in percent time spent in target glycemic range (TIR, glucose 70-180 mg/dL, both values included) in the 48 hours before and the 48 hours after the 1st dose of IDeg.
Secondary Outcome Measures
Coefficient of variation (CV) of percent-time-in-range
Change in CV in the 48 hours before and the 48 hours after the 1st dose of IDeg.
Nocturnal percent time in range of 70-180 mg/dL
Change in the nocturnal percent time in range in the 48 hours before and the 48 hours after the 1st dose of IDeg.
Percent time above 180 mg/dL (TAR-1), percent time above 250 mg/dL (TAR-2)
Change in the percent time above range (TAR-1, TAR-2) in the 48 hours before and the 48 hours after the 1st dose of IDeg.
Percent time below 70 mg/dL (TBR-1), percent time below 54 mg/dL (TBR-2)
Change in the percent time below range (TBR-1, TBR-2) in the 48 hours before and the 48 hours after the 1st dose of IDeg.
Number of correction boluses
Change in the absolute number of correction boluses in the 48 hours before and the 48 hours after the 1st dose of IDeg.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04623086
Brief Title
Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose
Acronym
GLIDING
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
September 7, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Insulin glargine, insulin degludec
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin Glargine and Insulin Degludec
Arm Type
Experimental
Arm Description
Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily
Arm Title
Insulin Degludec and placebo
Arm Type
Placebo Comparator
Arm Description
Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily
Intervention Type
Drug
Intervention Name(s)
Insulin Degludec
Other Intervention Name(s)
Tresiba
Intervention Description
Insulin Degludec injection
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Other Intervention Name(s)
Lantus
Intervention Description
Insulin Glargine injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection
Primary Outcome Measure Information:
Title
Mean change in percent time in range
Description
Change in percent time spent in target glycemic range (TIR, glucose 70-180 mg/dL, both values included) in the 48 hours before and the 48 hours after the 1st dose of IDeg.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Coefficient of variation (CV) of percent-time-in-range
Description
Change in CV in the 48 hours before and the 48 hours after the 1st dose of IDeg.
Time Frame
4 days
Title
Nocturnal percent time in range of 70-180 mg/dL
Description
Change in the nocturnal percent time in range in the 48 hours before and the 48 hours after the 1st dose of IDeg.
Time Frame
4 days
Title
Percent time above 180 mg/dL (TAR-1), percent time above 250 mg/dL (TAR-2)
Description
Change in the percent time above range (TAR-1, TAR-2) in the 48 hours before and the 48 hours after the 1st dose of IDeg.
Time Frame
4 days
Title
Percent time below 70 mg/dL (TBR-1), percent time below 54 mg/dL (TBR-2)
Description
Change in the percent time below range (TBR-1, TBR-2) in the 48 hours before and the 48 hours after the 1st dose of IDeg.
Time Frame
4 days
Title
Number of correction boluses
Description
Change in the absolute number of correction boluses in the 48 hours before and the 48 hours after the 1st dose of IDeg.
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients must meet ALL inclusion criteria to be included in the study.
Patient age is 18-75 years.
Diagnosis of T1D of at least 1-year duration.
Has the ability to provide informed consent before any trial-related activities.
Treated with insulin glargine as their basal insulin in the 3 months preceding screening visit.
Stable insulin regimen (defined as change of <20% in the total daily dose of insulin and no change to the basal insulin agent) over the 3 months preceding the screening visit.
Patient willing to dose their basal insulin at bedtime.
Hemoglobin A1c < 9% in the 3 months preceding screening visit.
Able to self-administer their insulin doses.
Able to do self-monitoring of blood glucose using a glucose meter and willing to do this at least 2 times daily for patients using a CGM that requires calibration prior to the study and 4 times daily for patients who were not using a CGM prior to the study.
Agreeable to the use of a continuous glucose monitor (CGM) for the duration required in the study. If already using a CGM prior to the study, then agreeable to wearing the blinded study CGM concurrently during the study period.
Will be reachable by phone and/or email to comply with study procedures.
Will be able to comply with study procedures, per investigator's opinion.
Patient agrees to not use correctional insulin unless BG ≥250 for the 48 hours before and after 1st dose of IDeg.
Exclusion Criteria:
Patient must not have ANY of the exclusion criteria to be included in the study.
Patients with eGFR <30 on at least 2 measurements within 1-year of the screening visit.
History of myocardial infarction within 6 months preceding the screening visit.
Patients taking non-insulin medications for the glycemic management of T1D (including metformin, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 inhibitors, thiazolidinediones, alpha-glucosidase inhibitors, pramlintide)
Known or suspected allergy to IDeg or one of its excipients.
Pregnant, planning to become pregnant in the next 3 months or breastfeeding.
Participation in a clinical trial with investigational drug within 1 month of the screening visit or at present.
Skin condition that prevents the insertion of the CGM.
Previously randomized and received drug in this study.
Presence of decompensated or poorly controlled psychiatric conditions.
Current known or suspected illicit substance use.
Any anticipated surgery or procedure in the next 14 days.
Patients using U-300 glargine as their basal insulin.
Patients using insulin afrezza as their short-acting insulin.
Use of glucocorticoid burst/pulse therapy within 14 days prior to screening visit (chronic stable glucocorticoid doses are acceptable).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthi Thirumalai, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Medicine Diabetes Institute at South Lake Union
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
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Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose
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