DiabetesPhase 2NCT01923181

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

A Phase 2 study testing semaglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 103 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: semaglutide
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 632 participants
Where: 103 sitesin 14 countries
Study dates: 2 Dec 2013to 11 Dec 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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
Treatment with glucose lowering agent(s) other than metformin as stated in the inclusion criteria in a period of 90 days before the screening visit

Trial locations and contacts

103 sites in 14 countries.

Country

City, postcode or hospital

103 sites in 14 countries

United States40 sites

Novo Nordisk Investigational Site
Addison, Illinois, 60101
Novo Nordisk Investigational Site
Asheville, North Carolina, 28801
Novo Nordisk Investigational Site
Athens, Georgia, 30606
Novo Nordisk Investigational Site
Chicago, Illinois, 60634
Novo Nordisk Investigational Site
Chula Vista, California, 91911
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80904
Novo Nordisk Investigational Site
Conyers, Georgia, 30094-5965
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Denver, Colorado, 80220
Novo Nordisk Investigational Site
Fargo, North Dakota, 58104
Novo Nordisk Investigational Site
Humboldt, Tennessee, 38343
Novo Nordisk Investigational Site
Jacksonville, Florida, 32207
Novo Nordisk Investigational Site
Jersey Shore, Pennsylvania, 17740
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89103
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89109
Novo Nordisk Investigational Site
Long Beach, California, 90806
Novo Nordisk Investigational Site
Miami, Florida, 33014
Novo Nordisk Investigational Site
Moncks Corner, South Carolina, 29461
Novo Nordisk Investigational Site
New York, New York, 10001
Novo Nordisk Investigational Site
New York, New York, 10032
Novo Nordisk Investigational Site
Newport News, Virginia, 23606
Novo Nordisk Investigational Site
Norman, Oklahoma, 73069
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19140
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19147
Novo Nordisk Investigational Site
Plantation, Florida, 33324
Novo Nordisk Investigational Site
Poway, California, 92064
Novo Nordisk Investigational Site
Raleigh, North Carolina, 27609
Novo Nordisk Investigational Site
Rochester, New York, 14609
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
Salisbury, North Carolina, 28144
Novo Nordisk Investigational Site
San Antonio, Texas, 78209
Novo Nordisk Investigational Site
Santa Ana, California, 92705
Novo Nordisk Investigational Site
South Miami, Florida, 33143
Novo Nordisk Investigational Site
Spring Hill, Tennessee, 37174
Novo Nordisk Investigational Site
Spring Valley, California, 91978
Novo Nordisk Investigational Site
Sugar Land, Texas, 77478
Novo Nordisk Investigational Site
Tucson, Arizona, 85712
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
Novo Nordisk Investigational Site
Wenatchee, Washington, 98801-2028
Novo Nordisk Investigational Site
Wichita, Kansas, 67205

Other trials in United States

United Kingdom8 sites

Novo Nordisk Investigational Site
Belfast, BT16 1RH
Novo Nordisk Investigational Site
Bexhill-on-Sea, TN39 4SP
Novo Nordisk Investigational Site
Chester, CH2 1UL
Novo Nordisk Investigational Site
Chesterfield, Derbyshire, S40 4AA
Novo Nordisk Investigational Site
Crewe, CW5 5NX
Novo Nordisk Investigational Site
Hinckley, LE10 2SE
Novo Nordisk Investigational Site
Leicester, LE5 4PW
Novo Nordisk Investigational Site
London, W6 7HY

Other trials in United Kingdom

Germany7 sites

Novo Nordisk Investigational Site
Elsterwerda, 04910
Novo Nordisk Investigational Site
Falkensee, 14612
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Hamburg, 22607
Novo Nordisk Investigational Site
Münster, 48145
Novo Nordisk Investigational Site
Saint Ingbert-Oberwürzbach, 66386
Novo Nordisk Investigational Site
Speyer, 67346

Other trials in Germany

Israel7 sites

Novo Nordisk Investigational Site
Beersheba, 84101
Novo Nordisk Investigational Site
Haifa, 31096
Novo Nordisk Investigational Site
Herzliya, 46851
Novo Nordisk Investigational Site
Holon, 58100
Novo Nordisk Investigational Site
Jerusalem, 91120
Novo Nordisk Investigational Site
Kfar Saba, 44281
Novo Nordisk Investigational Site
Rishon LeZiyyon, 75650

Other trials in Israel

Austria6 sites

Novo Nordisk Investigational Site
Graz, 8036
Novo Nordisk Investigational Site
Saint Stefan, 8511
Novo Nordisk Investigational Site
Vienna, 1010
Novo Nordisk Investigational Site
Vienna, 1030
Novo Nordisk Investigational Site
Vienna, 1060
Novo Nordisk Investigational Site
Vienna, 1130

Other trials in Austria

Canada6 sites

Novo Nordisk Investigational Site
Bathurst, New Brunswick, E2A 4Z9
Novo Nordisk Investigational Site
Burlington, Ontario, L7R 1E2
Novo Nordisk Investigational Site
Moncton, New Brunswick, E1G 1A7
Novo Nordisk Investigational Site
Pointe-Claire, Quebec, H9R 3J1
Novo Nordisk Investigational Site
Stayner, Ontario, L0M 1S0
Novo Nordisk Investigational Site
Toronto, Ontario, M9W 4L6

Other trials in Canada

Denmark6 sites

Novo Nordisk Investigational Site
Aalborg, 9100
Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Esbjerg, 6700
Novo Nordisk Investigational Site
Hellerup, 2900
Novo Nordisk Investigational Site
Hillerød, 3400
Novo Nordisk Investigational Site
Svendborg, 5700

Other trials in Denmark

Italy5 sites

Novo Nordisk Investigational Site
Milan, 20132
Novo Nordisk Investigational Site
Padova, 35128
Novo Nordisk Investigational Site
Roma, 00133
Novo Nordisk Investigational Site
Roma, 00161
Novo Nordisk Investigational Site
Verona, 37126

Other trials in Italy

Spain5 sites

Novo Nordisk Investigational Site
Almería, 04001
Novo Nordisk Investigational Site
Sabadell, 08208
Novo Nordisk Investigational Site
Seville, 41003
Novo Nordisk Investigational Site
Seville, 41010
Novo Nordisk Investigational Site
Valencia, 46026

Other trials in Spain

Malaysia4 sites

Novo Nordisk Investigational Site
George Town, 10450
Novo Nordisk Investigational Site
Ipoh, 30450
Novo Nordisk Investigational Site
Kota Bharu, 15586
Novo Nordisk Investigational Site
Seri Manjung, 32040

Other trials in Malaysia

Sweden4 sites

Novo Nordisk Investigational Site
Karlstad, 651 85
Novo Nordisk Investigational Site
Linköping, 582 16
Novo Nordisk Investigational Site
Örebro, 701 85
Novo Nordisk Investigational Site
Oskarshamn, 572 28

Other trials in Sweden

South Africa3 sites

Novo Nordisk Investigational Site
Johannesburg, Gauteng, 1829
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2090
Novo Nordisk Investigational Site
Port Elizabeth, Eastern Cape, 6045

Other trials in South Africa

Bulgaria1 site

Novo Nordisk Investigational Site
Sofia, 1431

Other trials in Bulgaria

Serbia1 site

Novo Nordisk Investigational Site
Belgrade, 11000

Other trials in Serbia

About this study

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.

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: semaglutide, oral placebo
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

semaglutideDrug
Once-daily oral administration as tablets.
semaglutideDrug
Once-weekly,injected s.c./subcutaneously (under the skin) using a pen
oral placeboDrug
Once-daily oral administration as tablets.

Study groups in NCT01923181
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 0, week 26

Secondary outcomes (6)

Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)
Participants who achieved HbA1c <7.0%, 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.
Measured: After 26 weeks of treatment
Change in Body Weight
Change from baseline (week 0) in body weight 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.
Measured: Week 0, Week 26
Change in Waist Circumference
Change from baseline (week 0) in waist circumference 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.
Measured: Week 0, week 26
Change in Body Mass Index (BMI)
Change from baseline (week 0) in body mass index (BMI) 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.
Measured: Week 0, week 26
Number of Treatment Emergent Adverse Events (TEAEs) Recorded
TEAEs were recorded during weeks 0-31 (26 weeks treatment period+5 weeks follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Measured: Weeks 0-31
Number of Confirmed Hypoglycaemic Episodes Recorded
Treatment-emergent confirmed hypoglycaemic episodes were recorded during weeks 0-31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Confirmed hypoglycaemic episode is an episode that is severe according to the American Diabetes Association (ADA) classification or plasma glucose value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.
Measured: Weeks 0-31

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 201311 Dec 2014

First posted15 Aug 2013 (estimated)
Study start2 Dec 2013
Primary completion11 Dec 2014
Study completion11 Dec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 632 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01923181
Sponsor's protocol ID: NN9924-3790
Other IDs: 2012-004994-16, U1111-1136-4716
Status last verified: Jan 2021
First submitted: 13 Aug 2013
Last updated: 15 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Davies M, Pieber TR, Hartoft-Nielsen ML, Hansen OKH, Jabbour S, Rosenstock J. Effect of Oral Semaglutide Compared With Placebo and Subcutaneous Semaglutide on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2017 Oct 17;318(15):1460-1470. doi: 10.1001/jama.2017.14752.
PubMed 29049653

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT01923181
Acronym / sponsor ID: NN9924-3790
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 632 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 2 Dec 2013 (actual)
Primary completion: 11 Dec 2014 (actual)
Study completion: 11 Dec 2014 (actual)
First posted: 15 Aug 2013 (estimated)
Results: Posted 5 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
1:Semaglutide tablets : 2.5 mg	Experimental	Drug: semaglutide2.5 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.
2:Semaglutide tablets: 2.5 mg/5 mg	Experimental	Drug: semaglutide2.5 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.
3:Semaglutide tablets: 5.0 mg/10 mg	Experimental	Drug: semaglutide5.0 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.
4:Semaglutide tablets:5.0 mg/10 mg/20 mg	Experimental	Drug: semaglutide5.0 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.
5:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg	Experimental	Drug: semaglutide5.0 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.
6:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg	Experimental	Drug: semaglutide5.0 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.
7:Semaglutide tablets: 5.0 mg/10 mg/20 mg/40 mg	Experimental	Drug: semaglutide5.0 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.
8:Placebo tablets	Placebo comparator	Drug: oral placeboAll 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.
9:Semaglutide injections :0.25 mg/0.50 mg/1.0 mg	Active comparator	Drug: semaglutide0.25 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (5 listed)

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
Treatment with glucose lowering agent(s) other than metformin as stated in the inclusion criteria in a period of 90 days before the screening visit

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
semaglutideOnce-daily oral administration as tablets.	Drug	1:Semaglutide tablets : 2.5 mg, 2:Semaglutide tablets: 2.5 mg/5 mg, 3:Semaglutide tablets: 5.0 mg/10 mg, 4:Semaglutide tablets:5.0 mg/10 mg/20 mg, 5:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg, 6:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg, 7:Semaglutide tablets: 5.0 mg/10 mg/20 mg/40 mg
semaglutideOnce-weekly,injected s.c./subcutaneously (under the skin) using a pen	Drug	9:Semaglutide injections :0.25 mg/0.50 mg/1.0 mg
oral placeboOnce-daily oral administration as tablets.	Drug	8:Placebo tablets

Primary outcome

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

6 secondary outcomes

Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)
Time frame: After 26 weeks of treatment
Change in Body Weight
Time frame: Week 0, Week 26
Change in Waist Circumference
Time frame: Week 0, week 26
Change in Body Mass Index (BMI)
Time frame: Week 0, week 26
Number of Treatment Emergent Adverse Events (TEAEs) Recorded
Time frame: Weeks 0-31
Number of Confirmed Hypoglycaemic Episodes Recorded
Time frame: Weeks 0-31

Results and safety

Results posted to the registry on 5 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oral Semaglutide 2.5 mg	70	67
Oral Semaglutide 5 mg	70	64
Oral Semaglutide 10 mg	69	67
Oral Semaglutide 20 mg	70	65
Oral Semaglutide 40 mg	71	63
Oral Semaglutide 40 mg Slow Dose-escalation	70	66
Oral Semaglutide 40 mg Fast Dose-escalation	70	62
Subcutaneous Semaglutide 1 mg	69	61
Placebo	71	68

Primary outcome: Change in HbA1c (Glycosylated Haemoglobin)

Time frame: Week 0, week 26. Mean (Standard Deviation). Unit: Percentage of HbA1c

Measure	Oral Semaglutide 2.5 mg n = 56	Oral Semaglutide 5 mg n = 58	Oral Semaglutide 10 mg n = 57	Oral Semaglutide 20 mg n = 48	Oral Semaglutide 40 mg n = 46	Oral Semaglutide 40 mg Slow Dose-escalation n = 52	Oral Semaglutide 40 mg Fast Dose-escalation n = 44	Oral Semaglutide 40 mg Pooled n = 90	Subcutaneous Semaglutide 1 mg n = 48	Placebo n = 51
Value	-0.88 (0.77)	-1.23 (0.79)	-1.56 (0.92)	-1.70 (0.75)	-2.04 (0.90)	-1.76 (0.92)	-1.65 (0.77)	-1.85 (0.86)	-1.85 (0.75)	-0.40 (0.84)

Oral Semaglutide 40 mg Pooled vs Placebo: Mean treatment difference: -1.47 (95% CI -1.73 to -1.22), p <0.0001, Mixed Models Analysis
Oral Semaglutide 2.5 mg vs Placebo: Treatment difference: -0.40 (95% CI -0.69 to -0.11), p = 0.0069, Mixed Models Analysis
Oral Semaglutide 5 mg vs Placebo: Treatment difference: -0.89 (95% CI -1.18 to -0.60), p <0.0001, Mixed Models Analysis

Population analysed: Overall number of participants analyzed = number of participants with available data.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oral Semaglutide 2.5 mg	1 of 70 (1.4%)	35 of 70 (50%)	0 of 70
Oral Semaglutide 5 mg	2 of 70 (2.9%)	32 of 70 (45.7%)	0 of 70
Oral Semaglutide 10 mg	2 of 69 (2.9%)	37 of 69 (53.6%)	0 of 69
Oral Semaglutide 20 mg	0 of 70 (0%)	49 of 70 (70%)	0 of 70
Oral Semaglutide 40 mg	1 of 71 (1.4%)	49 of 71 (69%)	0 of 71
Oral Semaglutide 40 mg Slow Dose-escalation	3 of 70 (4.3%)	42 of 70 (60%)	0 of 70
Oral Semaglutide 40 mg Fast Dose-escalation	5 of 70 (7.1%)	55 of 70 (78.6%)	0 of 70
Subcutaneous Semaglutide 1 mg	2 of 69 (2.9%)	44 of 69 (63.8%)	0 of 69
Placebo	5 of 71 (7%)	34 of 71 (47.9%)	0 of 71

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29049653Davies M, Pieber TR, Hartoft-Nielsen ML, Hansen OKH, Jabbour S, Rosenstock J. Effect of Oral Semaglutide Compared With Placebo and Subcutaneous Semaglutide on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2017 Oct 17;318(15):1460-1470. doi: 10.1001/jama.2017.14752.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

103 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing semaglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 103 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States, United Kingdom, Germany, Israel, Austria and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01923181, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.