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

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Feb 2, 2017

Status verified

Feb 2020

Primary completion

Jan 18, 2018

Completion

Aug 22, 2018

Study Design

Enrollment

731 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide 3 mg
• Experimental: Semaglutide 3 mg + 7 mg
• Experimental: Semaglutide 3 mg + 7 mg + 14 mg
• Placebo Comparator: Placebo

Primary Outcome Measure

Change in HbA1c (Week 26) [ Time Frame: Week 0, week 26 ]

Locations (50)

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