Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

632

participants targeted

Target at P75+ for phase_2 diabetes

Timeline

Completed

Started Dec 2013

Shorter than P25 for phase_2 diabetes

Geographic Reach

13 countries

102 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

First Submitted

Initial submission to the registry

August 13, 2013

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2013

Completed

4 months until next milestone

Study Start

First participant enrolled

December 2, 2013

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2014

Completed

4.9 years until next milestone

Results Posted

Study results publicly available

November 5, 2019

Completed

Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

August 13, 2013

Results QC Date

October 15, 2019

Last Update Submit

January 14, 2021

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c (Glycosylated Haemoglobin)
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.
Week 0, week 26

Secondary Outcomes (6)

Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)
After 26 weeks of treatment
Change in Body Weight
Week 0, Week 26
Change in Waist Circumference
Week 0, week 26
Change in Body Mass Index (BMI)
Week 0, week 26
Number of Treatment Emergent Adverse Events (TEAEs) Recorded
Weeks 0-31
+1 more secondary outcomes

Study Arms (9)

1:Semaglutide tablets : 2.5 mg

EXPERIMENTAL

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.

Drug: semaglutide

2:Semaglutide tablets: 2.5 mg/5 mg

EXPERIMENTAL

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.

Drug: semaglutide

3:Semaglutide tablets: 5.0 mg/10 mg

EXPERIMENTAL

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.

Drug: semaglutide

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

EXPERIMENTAL

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.

Drug: semaglutide

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

EXPERIMENTAL

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.

Drug: semaglutide

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

EXPERIMENTAL

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.

Drug: semaglutide

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

EXPERIMENTAL

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.

Drug: semaglutide

8:Placebo tablets

PLACEBO COMPARATOR

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.

Drug: oral placebo

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

ACTIVE COMPARATOR

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.

Drug: semaglutide

Interventions

semaglutideDRUG

Once-daily oral administration as tablets.

1:Semaglutide tablets : 2.5 mg2:Semaglutide tablets: 2.5 mg/5 mg3:Semaglutide tablets: 5.0 mg/10 mg4:Semaglutide tablets:5.0 mg/10 mg/20 mg5:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg6:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg7:Semaglutide tablets: 5.0 mg/10 mg/20 mg/40 mg

oral placeboDRUG

Once-daily oral administration as tablets.

8:Placebo tablets

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

BMI above or equal to 25 and below or equal to 40 kg/m\^2
Subjects diagnosed with T2D (Type 2 diabetes) treated with diet and exercise and/or who have been on a stable dose of metformin for at least 30 days prior to screening
HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive)

You may not qualify if:

Subjects on selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants
History of chronic pancreatitis or idiopathic acute pancreatitis
Chronic malabsorption, regardless of aetiology
History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease

Contact the study team to confirm eligibility.