NCT02906930 (PIONEER 1) is a Phase 3 clinical trial of semaglutide in Diabetes, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT02906930?

NCT02906930 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT02906930?

Interventions in NCT02906930: semaglutide, placebo.

What condition does NCT02906930 study?

NCT02906930 studies Diabetes, Diabetes Mellitus, Type 2.

Is NCT02906930 still recruiting?

NCT02906930 is currently completed. Last updated 20 July 2022.

Are results published for NCT02906930?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-07-20 · How we verify

NCT02906930: PIONEER 1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 20 July 2022

What this trial tests

Phase 3 trial testing semaglutide in Diabetes in 703 participants. Completed in 8 December 2017.

Timeline

20 September 2016

Primary endpoint
30 October 2017

8 December 2017

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	703
Start date	20 September 2016
Primary completion	30 October 2017
Estimated completion	8 December 2017
Sites	105 locations across Italy, Japan, Russia, Serbia, Mexico, Romania, Bulgaria, Algeria

Drugs / interventions tested

semaglutide (semaglutide) — full drug profile →
placebo

Conditions studied

Diabetes — all drugs for Diabetes →
Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

18 and older, any sex, with Diabetes or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in HbA1c Primary · Week 0, week 26

Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c). The endpoint was evaluated based on data from the in-trial observation period. The in-trial observation period - time period from when a subject was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. The primary endpoint was also analysed based on data from the on-treatment without rescue medication observation period. The on-treatment without rescue medication observation period - time period when a subject was on trea

In-trial

Group	Value	95% CI
Oral Semaglutide 3 mg	-0.9	± 1.2
Oral Semaglutide 7 mg	-1.3	± 1.0
Oral Semaglutide 14 mg	-1.5	± 1.0
Placebo	-0.3	± 1.2

On-treatment without rescue medication

Group	Value	95% CI
Oral Semaglutide 3 mg	-0.9	± 1.2
Oral Semaglutide 7 mg	-1.4	± 0.9
Oral Semaglutide 14 mg	-1.6	± 1.0
Placebo	-0.3	± 1.2

Change in Body Weight (kg) Secondary · Week 0, week 26

Change from baseline (week 0) to week 26 in body weight. The endpoint was evaluated based on data from the in-trial observation period. The in-trial observation period - time period from when a subject was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. The primary endpoint was also analysed based on data from the on-treatment without rescue medication observation period. The on-treatment without rescue medication observation period - time period when a subject was on treatment with trial prod

In-trial

Group	Value	95% CI
Oral Semaglutide 3 mg	-1.5	± 3.3
Oral Semaglutide 7 mg	-2.6	± 4.1
Oral Semaglutide 14 mg	-4.0	± 4.2
Placebo	-1.4	± 3.5

On-treatment without rescue medication

Group	Value	95% CI
Oral Semaglutide 3 mg	-1.8	± 3.3
Oral Semaglutide 7 mg	-2.8	± 4.0
Oral Semaglutide 14 mg	-4.3	± 4.2
Placebo	-1.6	± 3.6

Change in Fasting Plasma Glucose Secondary · Week 0, week 26

Change from baseline (week 0) to week 26 in fasting plasma glucose. The endpoint was evaluated based on data from the in-trial observation period. The in-trial observation period - time period from when a subject was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Group	Value	95% CI
Oral Semaglutide 3 mg	-0.89	± 2.67
Oral Semaglutide 7 mg	-1.52	± 2.28
Oral Semaglutide 14 mg	-1.92	± 2.04
Placebo	-0.18	± 2.37

Change in Mean 7-point SMPG Profile Secondary · Week 0, week 26

Change from baseline (week 0) to week 26 in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomis

Group	Value	95% CI
Oral Semaglutide 3 mg	-1.8	± 2.3
Oral Semaglutide 7 mg	-2.1	± 2.0
Oral Semaglutide 14 mg	-2.3	± 2.4
Placebo	-0.5	± 2.6

Change in Mean Postprandial Increment Over All Meals in SMPG Secondary · Week 0, week 26

Change from baseline (week 0) to week 26 in the average of the post-prandial increments over all meals. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Group	Value	95% CI
Oral Semaglutide 3 mg	-0.4	± 2.3
Oral Semaglutide 7 mg	-0.8	± 2.0
Oral Semaglutide 14 mg	-1.2	± 2.1
Placebo	-0.3	± 2.0

Change in Fasting Insulin - Ratio to Baseline Secondary · Week 0, week 26

Change from baseline (week 0) to week 26 in fasting insulin (pmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product

Group	Value	95% CI
Oral Semaglutide 3 mg	1.12	± 59.2
Oral Semaglutide 7 mg	1.07	± 49.2
Oral Semaglutide 14 mg	0.98	± 45.0
Placebo	0.97	± 59.2

Change in Fasting Pro-insulin - Ratio to Baseline Secondary · Week 0, week 26

Change from baseline (week 0) to week 26 in fasting pro-insulin (pmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product

Group	Value	95% CI
Oral Semaglutide 3 mg	0.84	± 71.5
Oral Semaglutide 7 mg	0.74	± 74.3
Oral Semaglutide 14 mg	0.62	± 75.5
Placebo	0.89	± 76.5

Change in Fasting Glucagon - Ratio to Baseline Secondary · Week 0, week 26

Change from baseline (week 0) to week 26 in fasting glucagon (pg/mL) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product

Group	Value	95% CI
Oral Semaglutide 3 mg	1.00	± 28.2
Oral Semaglutide 7 mg	0.90	± 27.1
Oral Semaglutide 14 mg	0.89	± 25.7
Placebo	0.95	± 25.4

Change in HOMA-IR (Insulin Resistance) - Ratio to Baseline Secondary · Week 0, week 26

Change from baseline (week 0) to week 26 in homeostatic model assessment index of insulin resistance (HOMA-IR) (%) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Group	Value	95% CI
Oral Semaglutide 3 mg	1.00	± 74.6
Oral Semaglutide 7 mg	0.88	± 66.7
Oral Semaglutide 14 mg	0.76	± 60.4
Placebo	0.92	± 75.0

Change in HOMA-B (Beta-cell Function) - Ratio to Baseline Secondary · Week 0, week 26

Change from baseline (week 0) to week 26 in homeostatic model assessment index of beta-cell function (HOMA-B) (%) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Group	Value	95% CI
Oral Semaglutide 3 mg	1.40	± 73.2
Oral Semaglutide 7 mg	1.51	± 60.5
Oral Semaglutide 14 mg	1.60	± 58.4
Placebo	1.01	± 61.9

Change in CRP - Ratio to Baseline Secondary · Week 0, week 26

Change from baseline (week 0) to week 26 in C-reactive protein (CRP) (mg/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Group	Value	95% CI
Oral Semaglutide 3 mg	0.89	± 87.5
Oral Semaglutide 7 mg	0.72	± 118.2
Oral Semaglutide 14 mg	0.81	± 123.7
Placebo	0.99	± 108.3

Change in Body Weight (%) Secondary · Week 0, week 26

Change from baseline (week 0) to week 26 in body weight. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Group	Value	95% CI
Oral Semaglutide 3 mg	-1.67	± 4.08
Oral Semaglutide 7 mg	-2.85	± 4.57
Oral Semaglutide 14 mg	-4.71	± 5.00
Placebo	-1.37	± 3.58

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Oral Semaglutide 3 mg

Serious: 5/175 (3%)

Deaths: 0/175

Oral Semaglutide 7 mg

Serious: 3/175 (2%)

Deaths: 0/175

Oral Semaglutide 14 mg

Serious: 2/175 (1%)

Deaths: 1/175

Placebo

Serious: 8/178 (4%)

Deaths: 0/178

Serious adverse events (24 terms)

Reaction	System	Oral Semaglutide 3 mg	Oral Semaglutide 7 mg	Oral Semaglutide 14 mg	Placebo
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Appendicitis perforated	Infections and infestations	—	—	—	—
Bacterial pyelonephritis	Infections and infestations	—	—	—	—
Blood calcitonin increased	Investigations	—	—	—	—
Cerebral infarction	Nervous system disorders	—	—	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—	—
Dermatitis allergic	Skin and subcutaneous tissue disorders	—	—	—	—
Hallucination, visual	Psychiatric disorders	—	—	—	—
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Ischaemic stroke	Nervous system disorders	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—
Neuroendocrine tumour of the lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Palatoplasty	Surgical and medical procedures	—	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—	—
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Prostate cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pyelonephritis acute	Infections and infestations	—	—	—	—
Rib fracture	Injury, poisoning and procedural complications	—	—	—	—
Shock	Vascular disorders	—	—	—	—
Thyroiditis subacute	Endocrine disorders	—	—	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Oral Semaglutide 3 mg	Oral Semaglutide 7 mg	Oral Semaglutide 14 mg	Placebo
Nausea	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Influenza	Infections and infestations	—	—	—	—

Most-reported serious reactions: Abdominal pain, Acute respiratory failure, Appendicitis perforated, Bacterial pyelonephritis, Blood calcitonin increased, Cerebral infarction, Cholecystitis acute, Cholelithiasis.

Data from ClinicalTrials.gov NCT02906930 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Intestinal Permeation Enhancers for Oral Delivery of Macromolecules: A Comparison between Salcaprozate Sodium (SNAC) and Sodium Caprate (C<sub>10</sub>).
Twarog C, Fattah S, Heade J, Maher S, et al · · 2019 · cited 153× · PMID 30781867 · DOI 10.3390/pharmaceutics11020078
Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk.
Husain M, Bain SC, Jeppesen OK, Lingvay I, et al · · 2020 · cited 144× · PMID 31903692 · DOI 10.1111/dom.13955
Semaglutide, a glucagon like peptide-1 receptor agonist with cardiovascular benefits for management of type 2 diabetes.
Mahapatra MK, Karuppasamy M, Sahoo BM. · · 2022 · cited 92× · PMID 34993760 · DOI 10.1007/s11154-021-09699-1
Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme.
Thethi TK, Pratley R, Meier JJ. · · 2020 · cited 90× · PMID 32267058 · DOI 10.1111/dom.14054
Therapeutic Potential of Semaglutide, a Newer GLP-1 Receptor Agonist, in Abating Obesity, Non-Alcoholic Steatohepatitis and Neurodegenerative diseases: A Narrative Review.
Mahapatra MK, Karuppasamy M, Sahoo BM. · · 2022 · cited 84× · PMID 35650449 · DOI 10.1007/s11095-022-03302-1
Use of GLP-1 Receptor Agonists and Occurrence of Thyroid Disorders: a Meta-Analysis of Randomized Controlled Trials.
Hu W, Song R, Cheng R, Liu C, et al · · 2022 · cited 72× · PMID 35898463 · DOI 10.3389/fendo.2022.927859
Levels of circulating semaglutide determine reductions in HbA1c and body weight in people with type 2 diabetes.
Overgaard RV, Hertz CL, Ingwersen SH, Navarria A, et al · · 2021 · cited 65× · PMID 34622228 · DOI 10.1016/j.xcrm.2021.100387
Incorporating and interpreting regulatory guidance on estimands in diabetes clinical trials: The PIONEER 1 randomized clinical trial as an example.
Aroda VR, Saugstrup T, Buse JB, Donsmark M, et al · · 2019 · cited 55× · PMID 31168921 · DOI 10.1111/dom.13804

Verify or expand the search:

Other trials of semaglutide

Trials testing the same drug.

NCT07485062 — Exercise and Diabetes Interventions to Improve Brain Health in Older Adults With Type 2 Diabetes · Phase 4 · not yet recruiting
NCT07523633 — Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder · Phase 2 · recruiting
NCT07466017 — A Study of CS060380 Tablets in Patients With MASH and Obesity · Phase 2 · recruiting
NCT06975111 — Focusing on the Menopausal Transition to Improve Mid-Life Women's Health · Phase 2, PHASE3 · recruiting
NCT07213466 — Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder · Phase 4 · recruiting

Other recruiting trials for Diabetes

Currently open trials in the same condition.

NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
NCT07479134 — Production of Stem Cells for the Generation of Pancreatic Cells · NA · recruiting
NCT07441655 — Families Implementing Good Health Traditions for Life · NA · recruiting
NCT06724172 — CHIME: Comparing Health Interventions for Maternal Equity · NA · recruiting
NCT07417865 — ECHO Diabetes FQHC · recruiting

Other Novo Nordisk A/S trials

Trials by the same sponsor.

NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02906930 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 20 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02906930.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing