This site is intended for healthcare professionals
Clinical trials
  • Home
  • /
  • Clinical trials
  • /
  • Ozempic
  • /
  • A Research Study to Compare Two Doses of Semagluti...
Clinical trial

A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes (SUSTAIN FORTE)

Read time: 3 mins
Last updated:18th Jun 2019
Identifier: NCT03989232

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 Type: Interventional  (Clinical Trial)
Estimated Enrollment: 964 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: June 19, 2019
Estimated Primary Completion Date: September 16, 2020
Estimated Study Completion Date: November 11, 2020

- Experimental:
Semaglutide 2.0 mg
- Active Comparator: Semaglutide 1.0 mg

Category Value
Date last updated at source 2019-07-08
Study type(s) Interventional
Expected enrolment 964
Study start date 2019-06-19
Estimated primary completion date 2020-09-16

View full details