CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 703 enrolled
Drug / intervention
semaglutide +1 moredrug
Likely dose
Oral semaglutide, once dailyAI-extracted
Key inclusion· 4
  • ✓Age ≥18 years (≥20 in Japan, ≥19 in Algeria) at informed consent
  • ✓Diagnosed with type 2 diabetes mellitus ≥30 days before screening
  • ✓HbA1c 7.0–9.5% (53–80 mmol/mol)
  • ✓Currently treated with diet and exercise only for ≥30 days before screening
Key exclusion· 8
  • ✕Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
  • ✕History of acute or chronic pancreatitis
  • ✕Prior major stomach surgery (gastrectomy, sleeve gastrectomy, gastric bypass) that may affect absorption
  • ✕Myocardial infarction, stroke, unstable angina, or transient ischaemic attack hospitalization within 180 days before screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02906930
NCT02906930Phase 3Completed
CompareCT.gov

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only.

Novo Nordisk A/S·interventional·Posted Sep 20, 2016·Updated Jul 20, 2022

In Brief

A Phase 3 clinical trial evaluating semaglutide and placebo for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 703 participants across 105 sites in 11 countries.

Detailed Summary

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated with diet and exercise only.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesAlgeria, Bulgaria, Czechia, Italy, Japan, Mexico, Romania, Russia, Serbia, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 20, 2016
Enrollment StartSep 20, 2016
Primary CompletionOct 30, 2017
Study CompletionDec 8, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.8 years ago

Interventions

semaglutidedrug

Oral administration once daily.

placebodrug

Oral administration once daily.