A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• semaglutide — DRUG
  For oral use once daily.
• placebo — DRUG
  For oral use once daily.

Study Details

This trial is conducted globally. The aim of the trial is to investigate the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes.

Key Dates

Start date

Jan 17, 2017

Status verified

Jul 2022

Primary completion

Sep 25, 2018

Completion

Sep 25, 2018

Study Design

Enrollment

3,183 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Oral semaglutide
• Placebo Comparator: Placebo

Primary Outcome Measure

Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke [ Time Frame: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period. ]

Locations (71)

Find similar trials in Little Rock, AR

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