TRANSITION-T2D

CompletedPhase 4Results posted

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

Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With Type-2 Diabetes Mellitus (TRANSITION-T2D) A Prospective Randomized Controlled Trial

Lead sponsor

The Cleveland Clinic

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≤7.5%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04538352

Org study ID20-853

Timeline

Milestones

Study first posted2020-09-04actual

Study start2021-01-18actual

Primary completion2023-03-31actual

Study completion2023-11-01actual

Results first posted2024-07-29actual

Last update posted2025-02-18actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/registry result

Mean Weight Change

Time frame:26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kg	95% CI
Once-weekly sc Semaglutide Combined With Once-daily Insulin	-8.6	-9.6 – -7.6
MDI Requiring Multiple Daily Injections of Insulin	1.4	0 – 2.8

p<0.001Bonferroni-adjusted p-value

Secondary/protocol endpoint

Mean Weight Change

Time frame:26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/registry result

Mean Change in HbA1C ≤ 7.5%

Time frame:26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), % glycated hemoglobin	95% CI
Once-weekly sc Semaglutide Combined With Once-daily Insulin	-0.5	-0.7 – -0.3
MDI Requiring Multiple Daily Injections of Insulin	0	-0.3 – 0.3

p0.009Bonferroni-adjusted p-value

Primary/protocol endpoint

Mean Change in HbA1C ≤ 7.5%

Time frame:26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Mean Change From Baseline in A1C

Time frame:26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), actual mean A1C change	95% CI
Once-weekly sc Semaglutide Combined With Once-daily Insulin	-.5	-.7 – -.3
MDI Requiring Multiple Daily Injections of Insulin	0	-.3 – .3

Secondary/registry result/low confidence

Total Daily Insulin Dose

Time frame:26 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units per day of total insulin	95% CI
Once-weekly sc Semaglutide Combined With Once-daily Insulin	-37.3	-41 – -33.6
MDI Requiring Multiple Daily Injections of Insulin	42.5	35.8 – 49.1

Secondary/protocol endpoint

Mean Change From Baseline in A1C

Time frame:26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Total Daily Insulin Dose

Time frame:26 weeks

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/registry result

Diabetes Treatment Satisfaction Comparison Between Groups

Time frame:26 weeks

change from baseline, improvement

Posted result

Group	Value (median), units on a scale	95% CI
Once-weekly sc Semaglutide Combined With Once-daily Insulin	18	15 – 18
MDI Requiring Multiple Daily Injections of Insulin	14	12.3 – 17.5

Secondary/protocol endpoint

Diabetes Treatment Satisfaction Comparison Between Groups

Time frame:26 weeks

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Hypoglycemic Episodes

Time frame:26 weeks

event count, event

Posted result

Group	Value (number), frequency of hypoglycemic episodes	95% CI
Once-weekly sc Semaglutide Combined With Once-daily Insulin	.7	.3 – 1.5
MDI Requiring Multiple Daily Injections of Insulin	1.4	.5 – 3.9

Secondary/protocol endpoint

Hypoglycemic Episodes

Time frame:26 weeks

descriptive, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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).
Diabetes, obesity & metabolism2025 Feb (month)PMID39532398doi:10.1111/dom.16057via CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.