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Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin

NCT03021187 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 731

Last updated 2020-03-02

Study results available
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Summary

This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated with insulin. All subjects should continue their pre-trial insulin therapy (basal, basal-bolus or premixed regimen including combinations of soluble insulins) throughout the trial. Subjects treated with metformin in addition to insulin treatment must continue their metformin treatment throughout the entire trial.

Conditions

Interventions

DRUG

semaglutide

Oral semaglutide administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment

DRUG

semaglutide

Oral semaglutide (3 mg followed by 7 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment

DRUG

semaglutide

Oral semaglutide (3 mg followed by 7 mg and finally 14 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment

DRUG

placebo

Oral semaglutide placebo administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-02
Primary Completion
2018-01-18
Completion
2018-08-22
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Greece
  • India
  • Japan
  • Mexico
  • Poland
  • Puerto Rico
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT03021187 on ClinicalTrials.gov