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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D

Short name TRANSITION-T2D

NCTNCT04538352 (opens ClinicalTrials.gov in a new tab)Other id20-853
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
60 participants (actual)
Sponsor
The Cleveland Clinic · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
18 Jan 2021
Primary completion
31 Mar 2023
Completion
1 Nov 2023
First posted
4 Sept 2020
Last update posted
18 Feb 2025
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 4

    TRANSITION-T2D

    NCT04538352

    18 Jan 2021 to 1 Nov 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study is designed to determine whether therapy with once-weekly sc semaglutide in combination with once-daily insulin degludec will be capable of maintaining (or improving) glycemic control, when substituted for multiple daily injections of insulin (MDI), in patients with T2D with adequate glycemic control (≤ 7.5%) on MDI-based regimens (≤ 80 units of insulin per day), vs. further titration of insulin therapy in those continuing MDI. Weight loss, hypoglycemic episodes, and improvement in diabetes-treatment satisfaction will also be assessed between the two groups.

Interventions

  • SemaglutideDrug
  • Insulin DegludecDrug
  • Insulin aspartDrug

Arms2

  • Experimental

    Once-weekly sc semaglutide combined with once-daily insulin

    Patients randomized to continue with MDI will be transitioned from their existing regimen to the rapid-acting insulin product insulin aspart and their basal insulin switched to once-daily insulin degludec.

  • Experimental

    MDI requiring multiple daily injections of insulin

    Patients randomized to MDI will be allowed to continue correction rapid-acting insulin, in addition to their prandial doses of rapid-acting insulin, throughout the duration of the study.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Mean Change in HbA1C ≤ 7.5%

    Time frame · 26 weeks

    Registry description

    Mean change in HbA1C ≤ 7.5% from baseline to 26 weeks between the two groups

Secondary outcomes(5)

  1. Mean Weight Change

    Time frame · 26 weeks

    Registry description

    Mean weight change from baseline in body weight at 26 weeks

  2. Hypoglycemic Episodes

    Time frame · 26 weeks

    Registry description

    Recorded for the overall study period

  3. Mean Change From Baseline in A1C

    Time frame · 26 weeks

    Registry description

    Change from baseline in A1C at week 26

  4. Diabetes Treatment Satisfaction Comparison Between Groups

    Time frame · 26 weeks

    Registry description

    Change from baseline in diabetes treatment satisfaction at week 26

  5. Total Daily Insulin Dose

    Time frame · 26 weeks

    Registry description

    Mean total insulin dose change (U/day) from baseline to week 26

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 26 weeks

Mean Change in HbA1C ≤ 7.5%

GroupValue (% glycated hemoglobin)
Once-weekly sc Semaglutide Combined With Once-daily Insulin-0.5
MDI Requiring Multiple Daily Injections of Insulin0
Secondary and other outcome results(5)
Secondary outcomeMean· 26 weeks

Mean Weight Change

GroupValue (Kg)
Once-weekly sc Semaglutide Combined With Once-daily Insulin-8.6
MDI Requiring Multiple Daily Injections of Insulin1.4
Secondary outcomeNumber· 26 weeks

Hypoglycemic Episodes

GroupValue (frequency of hypoglycemic episodes)
Once-weekly sc Semaglutide Combined With Once-daily Insulin.7
MDI Requiring Multiple Daily Injections of Insulin1.4
Secondary outcomeMean· 26 weeks

Mean Change From Baseline in A1C

GroupValue (actual mean A1C change)
Once-weekly sc Semaglutide Combined With Once-daily Insulin-.5
MDI Requiring Multiple Daily Injections of Insulin0
Secondary outcomeMedian· 26 weeks

Diabetes Treatment Satisfaction Comparison Between Groups

GroupValue (units on a scale)
Once-weekly sc Semaglutide Combined With Once-daily Insulin18
MDI Requiring Multiple Daily Injections of Insulin14
Secondary outcomeMean· 26 weeks

Total Daily Insulin Dose

GroupValue (units per day of total insulin)
Once-weekly sc Semaglutide Combined With Once-daily Insulin-37.3
MDI Requiring Multiple Daily Injections of Insulin42.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Once-weekly sc Semaglutide Combined With Once-daily InsulinPatients randomized to continue with MDI will be transitioned from their existing regimen to the rapid-acting insulin product insulin aspart and their basal insulin switched to once-daily insulin degludec. Semaglutide: Medication for type 2 diabetes management Insulin Degludec: Medication for type 2 diabetes management Insulin aspart: Medication for type 2 diabetes management (rapid-acting)0 / 409 / 407 / 40
MDI Requiring Multiple Daily Injections of InsulinPatients randomized to MDI will be allowed to continue correction rapid-acting insulin, in addition to their prandial doses of rapid-acting insulin, throughout the duration of the study. Insulin Degludec: Medication for type 2 diabetes management Insulin aspart: Medication for type 2 diabetes management (rapid-acting)1 / 205 / 203 / 20

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

10 results

De-intensification of basal-bolus therapy by replacing prandial insulin with once-weekly subcutaneous semaglutide in individuals with well-controlled type 2 diabetes: A single-centre, open-label randomised trial (TRANSITION-T2D).

Rodriguez et al. 2025Diabetes, obesity & metabolismcited by 5

PMID 39532398PMC11701190DOI 10.1111/dom.16057PUB-39532398

Free to read · publisher termsCC BY-NC10 results
Read at sourceSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Gender: men and women 2. Ethnicity: all ethnic groups 3. Language: English 4. Age: ≥ 18 to 75 years 5. Type II diabetes * Currently treated with MDI (basal/bolus regimen) for at least 6 months * MDI must consist of three or more injections of insulin per day, with at least 2 injections being prandial/rapid-acting insulin * Prandial insulin restricted to insulin aspart, glulisine, and lispro * Basal insulin restricted to long acting once-daily analogues (insulin glargine U- 100, insulin degludec (U-100 or U-200), or insulin glargine U-300) * A1C within 30 days of randomization must be ≤ 7.5% on the present therapy * Less than or equal to 120 units of total insulin therapy per day 6. Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject. Exclusion Criteria: 1. GAD-65 antibody positive 2. Current glucocorticoid therapy greater than 5 mg of daily prednisone (or equivalent dose of other glucocorticoid) 3. Known or suspected allergy to trial medication(s), excipients, or related products, i.e., GLP-1RA therapy or insulin aspart or insulin degludec. 4. The receipt of any investigational drug within 90 days prior to this trial. 5. Previous participation in this trial (Randomized) 6. Mental incapacity or language barrier (non-English speaking) 7. Use of incretin-based therapies \<3 months before inclusion in the study * DPP-4 inhibitors sitagliptin, saxagliptin, linagliptin, alogliptin * GLP-1RA (exenatide, liraglutide, exenatide LAR, dulaglutide, albiglutide, lixisenatide, semaglutide) * GLP-1RA/Basal Insulin combination (IGlarLixi, IDegLira) 8. Present use of oral anti-diabetic agents other than metformin and SGLT-2i. The dose of metformin and/or SGLT-2i must be unchanged and stable for the immediate 3 months prior to baseline. 9. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures 10. Personal or family history of medullary thyroid carcinoma 11. Personal or family history of Multiple Endocrine Neoplasia syndrome type 2 12. History of acute or chronic pancreatitis, severe liver disease or LFT's \> 2.5X ULN, or severe disease of digestive tract 13. History of bariatric surgery/procedure (gastric banding, gastric sleeve, or Roux-en-Y) 14. Known elevation of serum calcitonin \> 50 ng/L

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