Type 1 DiabetesPhase 4GLIDINGNCT04623086
Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose
A Phase 4 study testing Insulin Degludec and Insulin Glargine in people with Type 1 Diabetes, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insulin Degludec and Insulin Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2020to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medicine Diabetes Institute at South Lake Union
Seattle, Washington, 98109
About this study
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
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.
Read the 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
- Being tested
- Insulin Degludec, Insulin Glargine, Placebo
- Keywords
- Insulin glargine, insulin degludec
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin DegludecDrug
Also called Tresiba
Insulin Degludec injection
Insulin GlargineDrug
Also called Lantus
Insulin Glargine injection
PlaceboDrug
9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection
| Study group | Role | What they receive |
|---|---|---|
| Insulin Glargine and Insulin Degludec | Experimental | Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily Receives: Drug: Insulin Degludec; Drug: Insulin Glargine |
| Insulin Degludec and placebo | Placebo comparator | Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily Receives: Drug: Insulin Degludec; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours prior to 48 hours after 1st dose of degludec insulin
Secondary outcomes (7)
Coefficient of Variation (CV) of Percent-time-in-range
Change in coefficient of variation of glucose (CV) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)
Measured: 48 hours prior to 48 hours after 1st dose of degludec insulin
Nocturnal Percent Time in Range of 70-180 mg/dL Nocturnal Time in Range (N-TIR)
Change in nocturnal (defined as midnight to 0600 hours) time in range (glucose in 70-180 mg/dL range) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)
Measured: 4 days: Outcome Measure Time Frame 48 hours prior to 48 hours after 1st dose of degludec insulin
Percent Time Above 180 mg/dL (TAR-1)
Change in time above range (glucose in 181-250 mg/dL range, TAR-1) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)
Measured: 4 days
Time Above Range-2 (TAR-2)
Change in time above range (glucose above 250 mg/dL range, TAR-2) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)
Measured: 4 days
Time Below Range-1 (TBR-1)
Change in time below range (glucose 54-70 mg/dL range, TBR-1) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)
Measured: 48 hours prior to 48 hours after 1st dose of degludec insulin
Time Below Range-2 (TBR-2)
Change in time below range (glucose below 54 mg/dL range, TBR-2) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)
Measured: 48 hours prior to 48 hours after 1st dose of degludec insulin
Correction Boluses
Change in the number of daily correction boluses administered in the 48 hours before and 48 hours after the 1st dose of degludec insulin, as noted on insulin logs maintained by participants
Measured: 48 hours prior to 48 hours after 1st dose of degludec insulin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start14 Feb 2020
- Primary completion7 Sep 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthi Thirumalai, University of Washington
- Investigators
- Arthi Thirumalai, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623086
- Sponsor's protocol ID
- STUDY00008108
- Acronym
- GLIDING
- Status last verified
- Feb 2024
- First submitted
- 4 Nov 2020
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Thirumalai A, Chao JH, Kaleru T, Dong X, Mandava P, Khakpour D, Hirsch IB. Bridging dose of U-100 glargine with first dose of insulin degludec improves glycaemia in the 48 h after transition in twice-daily glargine users. Diabetes Obes Metab. 2024 May;26(5):1868-1876. doi: 10.1111/dom.15502. Epub 2024 Feb 28.
PubMed 38418413
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04623086
- Acronym / sponsor ID
- GLIDING / STUDY00008108
- Conditions
- Type 1 Diabetes
- Keywords
- Insulin glargine, insulin degludec
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Posted 28 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Glargine and Insulin Degludec | Experimental | Drug: Insulin Degludec, Drug: Insulin GlargineInsulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily |
| Insulin Degludec and placebo | Placebo comparator | Drug: Insulin Degludec, Drug: PlaceboInsulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must meet ALL inclusion criteria to be included in the study.
Key exclusion criteria (15 listed)
- Patient must not have ANY of the exclusion criteria to be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin DegludecAlso: TresibaInsulin Degludec injection | Drug | Insulin Degludec and placebo, Insulin Glargine and Insulin Degludec |
| Insulin GlargineAlso: LantusInsulin Glargine injection | Drug | Insulin Glargine and Insulin Degludec |
| Placebo9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection | Drug | Insulin Degludec and placebo |
Primary outcome
Mean Change in Percent Time in Range
Time frame: 48 hours prior to 48 hours after 1st dose of degludec insulin
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.
7 secondary outcomes
Coefficient of Variation (CV) of Percent-time-in-range
Time frame: 48 hours prior to 48 hours after 1st dose of degludec insulin
Nocturnal Percent Time in Range of 70-180 mg/dL Nocturnal Time in Range (N-TIR)
Time frame: 4 days: Outcome Measure Time Frame 48 hours prior to 48 hours after 1st dose of degludec insulin
Percent Time Above 180 mg/dL (TAR-1)
Time frame: 4 days
Time Above Range-2 (TAR-2)
Time frame: 4 days
Time Below Range-1 (TBR-1)
Time frame: 48 hours prior to 48 hours after 1st dose of degludec insulin
Time Below Range-2 (TBR-2)
Time frame: 48 hours prior to 48 hours after 1st dose of degludec insulin
Correction Boluses
Time frame: 48 hours prior to 48 hours after 1st dose of degludec insulin
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38418413Thirumalai A, Chao JH, Kaleru T, Dong X, Mandava P, Khakpour D, Hirsch IB. Bridging dose of U-100 glargine with first dose of insulin degludec improves glycaemia in the 48 h after transition in twice-daily glargine users. Diabetes Obes Metab. 2024 May;26(5):1868-1876. doi: 10.1111/dom.15502. Epub 2024 Feb 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthi Thirumalai, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin Degludec and Insulin Glargine in people with Type 1 Diabetes, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Percent Time in Range (time frame: 48 hours prior to 48 hours after 1st dose of degludec insulin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04623086, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.