Efficacy and safety of once-weekly semaglutide s.c. 2.0 mg as add-on to dose-reduced insulin glargine vs titrated insuline glargine in participants with type 2 diabetes and overweight

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510612-75-00

Acronym

NN9535-4801

Enrollment

398

Registered

2024-08-06

Start date

2022-08-31

Completion date

2025-04-01

Last updated

2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Participants with T2D and overweight

Brief summary

Change in HbA1c from baseline (week 0) to end of treatment (week 40)

Detailed description

Change in body weight from baseline (week 0) to end of treatment (week 40), Relative change in daily insulin dose from baseline (week 0) to end of treatment (week 40), Change in HbA1c From baseline (week 0) to end of treatment (week 40), Score of Diabetes Treatment Satisfaction Questionnaire – change version (DTSQc) At end of treatment (week 40)

Interventions

DRUGLantus SoloStar 100 units/ml solution for injection in a pre-filled pen

DRUGOzempic 2 mg solution for injection in pre-filled pen

DRUGOzempic 1 mg solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from baseline (week 0) to end of treatment (week 40)	—

Secondary

Measure	Time frame
Change in body weight from baseline (week 0) to end of treatment (week 40), Relative change in daily insulin dose from baseline (week 0) to end of treatment (week 40), Change in HbA1c From baseline (week 0) to end of treatment (week 40), Score of Diabetes Treatment Satisfaction Questionnaire – change version (DTSQc) At end of treatment (week 40)	—

Countries

Czechia, Greece, Italy, Portugal, Romania, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026