Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes

Status

Completed

Phase

Phase 2

Enrollment

632 participants (actual)

Sponsor

Novo Nordisk A/S · Industry

Design

Randomized · Double masking

Countries

14 countries

United States, Austria, Bulgaria, Canada, Denmark, Germany, Israel, Italy, Malaysia, Serbia, South Africa, Spain, Sweden, United Kingdom

Start

2 Dec 2013

Primary completion

11 Dec 2014

Completion

11 Dec 2014

First posted

15 Aug 2013 (estimated)

Last update posted

15 Jan 2021

Conditions

Diabetes · Diabetes Mellitus, Type 2

This trial is conducted globally. The aim of the trial is to examine the dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes.

• Experimental

  1:Semaglutide tablets : 2.5 mg

  2.5 mg for 26 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

• Experimental

  2:Semaglutide tablets: 2.5 mg/5 mg

  2.5 mg for 4 weeks, then 5.0 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

• Experimental

  3:Semaglutide tablets: 5.0 mg/10 mg

  5.0 mg for 4 weeks, then 10 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

• Experimental

  4:Semaglutide tablets:5.0 mg/10 mg/20 mg

  5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

• Experimental

  5:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg

  5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 4 weeks, then 40 mg for 14 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

• Experimental

  6:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg

  5.0 mg for 8 weeks, then 10 mg for 8 weeks, then 20 mg for 8 weeks, then 40 mg for 2 weeks All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

• Experimental

  7:Semaglutide tablets: 5.0 mg/10 mg/20 mg/40 mg

  5.0 mg for 2 weeks, then 10 mg for 2 weeks, then 20 mg for 2 weeks, then 40 mg for 20 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

• Placebo comparator

  8:Placebo tablets

  All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

• Active comparator

  9:Semaglutide injections :0.25 mg/0.50 mg/1.0 mg

  0.25 mg for 4 weeks, then 0.50 mg for 4 weeks, then 1.0 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

1. Change in HbA1c (Glycosylated Haemoglobin)

   Time frame · Week 0, week 26

   Registry description

   Change from baseline (week 0) in HbA1c was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.