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

NCT03989232 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 961

Last updated 2023-02-13

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Semaglutide

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

DRUG

Placebo (semaglutide)

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Reporting Anchor and Disclosure (1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-19
Primary Completion
2020-09-18
Completion
2020-11-09
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • Greece
  • Hungary
  • Japan
  • Poland
  • Puerto Rico
  • Slovakia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03989232 on ClinicalTrials.gov