Phase 4
Completed N=60
Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D
Source: ClinicalTrials.gov NCT04538352 ↗Enrolled (actual)
60
Serious AEs
23.3%
Results posted
Jul 2024
Primary outcomePrimary: Mean Change in HbA1C ≤ 7.5% — -0.5; 0 % glycated hemoglobin — p=0.009
◆ Published Evidence
Emerging
5citations · ~5 / year
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).
Summary
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.
Linked Publications
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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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in HbA1C ≤ 7.5% |
-0.5; 0 | 0.009 sig |
| SECONDARY Mean Weight Change |
-8.6; 1.4 | <0.001 sig |
| SECONDARY Hypoglycemic Episodes |
.7; 1.4 | — |
| SECONDARY Mean Change From Baseline in A1C |
-.5; 0 | — |
| SECONDARY Diabetes Treatment Satisfaction Comparison Between Groups |
18; 14 | — |
| SECONDARY Total Daily Insulin Dose |
-37.3; 42.5 | — |
Eligibility Criteria
Inclusion Criteria
- Gender: men and women
- Ethnicity: all ethnic groups
- Language: English
- Age: ≥ 18 to 75 years
- 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
- 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
- GAD-65 antibody positive
- Current glucocorticoid therapy greater than 5 mg of daily prednisone (or equivalent dose of other glucocorticoid)
- Known or suspected allergy to trial medication(s), excipients, or related products, i.e., GLP-1RA therapy or insulin aspart or insulin degludec.
- The receipt of any investigational drug within 90 days prior to this trial.
- Previous participation in this trial (Randomized)
- Mental incapacity or language barrier (non-English speaking)
- Use of incretin-based therapies 2.5X ULN, or severe disease of digestive tract
- History of bariatric surgery/procedure (gastric banding, gastric sleeve, or Roux-en-Y)
- Known elevation of serum calcitonin > 50 ng/L
Data sourced from ClinicalTrials.gov (NCT04538352) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.