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A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes

NCT04109547 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 521

Last updated 2024-09-19

Study results available
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Summary

The study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and placebo (a dummy medicine). Researchers will test semaglutide to see how well it works compared to placebo. The study will also test if semaglutide is safe. Participants will either get semaglutide or placebo - which treatment is decided by chance. Participants will get 1 tablet a day to take with up to half a glass of water. Participants must take the tablet first thing in the morning on an empty stomach. After taking the tablet, participants must not eat or drink anything for at least 30 minutes. After the 30 minutes, participants can have their first meal of the day and take any other medicines they may need. The study will last for about 8 months (36 weeks). Participants will have 9 clinic visits and 2 phone calls with the study doctor. At all 9 of the clinic visits, participants will have blood samples taken. At 5 of the clinic visits, participants must arrive fasting. This means they cannot eat for 8 hours before the visit. It is fine to drink water up to 2 hours before the visit. This is for some of the blood samples that will be taken at the visit. Women cannot take part if pregnant, breastfeeding or planning to become pregnant during the study period.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Oral semaglutide

Tablets to be taken once-daily for 26 weeks

DRUG

Placebo

Tablets to be taken once-daily for 26 weeks

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
2019-10-01
Primary Completion
2021-09-23
Completion
2021-10-27

Countries

  • Algeria
  • China
  • Hungary
  • Serbia
  • Taiwan
  • 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 NCT04109547 on ClinicalTrials.gov