Trial results for a Phase 3 study (NCT05514535) comparing semaglutide with a lower dose of insulin glargine to a higher dose of insulin glargine alone in people with Type 2 Diabetes and Obesity were posted on ClinicalTrials.gov on 2026-05-11. The combination therapy group achieved a mean reduction in HbA1c of 1.37 percentage points, compared to 0.65 percentage points in the titrated insulin glargine group. This was accompanied by a mean body weight reduction of 7.97 kilograms in the combination group.
Background
Semaglutide is a medication indicated for the management of Type 2 Diabetes and Obesity. This study investigated its use in combination with insulin glargine, a long-acting insulin, for patients with Type 2 Diabetes.
Trial design
The Phase 3 study, 'A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)', enrolled 573 participants with Type 2 Diabetes and Obesity. The trial compared two treatment arms over approximately 47 weeks: one receiving semaglutide with a reduced dose of insulin glargine U100, and the other receiving a titrated dose of insulin glargine U100 alone. The study assessed changes in glycated haemoglobin (HbA1c) and other outcomes.
Key results
Key findings from the study include:
- Glycated Haemoglobin (HbA1c): Participants in the semaglutide combination group achieved a mean reduction of -1.37 percentage points of HbA1c (Standard Deviation: 0.84), compared to a mean reduction of -0.65 percentage points of HbA1c (Standard Deviation: 0.92) in the titrated insulin glargine U100 group.
- Body Weight: The semaglutide combination group showed a mean reduction of -7.97 kilograms (Standard Deviation: 5.62), while the titrated insulin glargine U100 group had a mean increase of 0.39 kilograms (Standard Deviation: 4.08).
- Daily Insulin Dose: The semaglutide combination group experienced a mean reduction of -15.11% (Standard Deviation: 87.25) in daily insulin dose, whereas the titrated insulin glargine U100 group saw a mean increase of 103.42% (Standard Deviation: 142.38). Notably, 37 participants in the semaglutide combination group achieved an insulin dose of 0 units/mL, compared to 0 participants in the comparator group.
- Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score: The semaglutide combination group reported a mean score of 14.69 (Standard Deviation: 4.65), higher than the 12.11 (Standard Deviation: 6.84) in the titrated insulin glargine U100 group.
What this means
The results suggest that combining semaglutide with a lower dose of insulin glargine may offer superior glycemic control and significant body weight reduction compared to increasing the dose of insulin glargine alone in patients with Type 2 Diabetes and Obesity. The reduction in daily insulin dose and the ability for some participants to discontinue insulin entirely in the combination group indicate potential benefits for treatment simplification and patient satisfaction.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. Results for study NCT05514535, titled 'A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)', were posted on 2026-05-11 on clinicaltrials.gov.