CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 961 enrolled
Drug / intervention
Semaglutide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03989232
NCT03989232Phase 3Completed

Efficacy and Safety of Semaglutide 2.0 mg s.c. Once-weekly Compared to Semaglutide 1.0 mg s.c. Once-weekly in Subjects With Type 2 Diabetes

Novo Nordisk A/S·interventional·Posted Jun 18, 2019·Updated Feb 13, 2023

In Brief

A Phase 3 clinical trial evaluating Semaglutide and Placebo (semaglutide) for Diabetes Mellitus, Type 2. Completed, enrolled 961 participants across 129 sites in 11 countries.

Detailed Summary

This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D). People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance. Participants will inject semaglutide under the skin once a week. The study will last for about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study doctor. At the visits participants will have blood taken and eye tests done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Female participants who can get pregnant will be checked 11 times for pregnancy via urine tests.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Canada, Czechia, Greece, Hungary, Japan, Poland, Puerto Rico, Slovakia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 18, 2019
Enrollment StartJun 19, 2019
Primary CompletionSep 18, 2020
Study CompletionNov 9, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.0 years ago

Interventions

Semaglutidedrug

Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.

Placebo (semaglutide)drug

Semaglutide placebo injected once-weekly from week 13 to week 40.