A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes

NCT04109547 | Completed Phase 3 Results

• 3 other identifiers: NN9924-4338U1111-1188-11732018-002590-22
• Study Type: interventional
• Target: 521
• Locations: 6 countries
• Sites: 66

Brief Summary

The study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and placebo (a dummy medicine). Researchers will test semaglutide to see how well it works compared to placebo. The study will also test if semaglutide is safe. Participants will either get semaglutide or placebo - which treatment is decided by chance. Participants will get 1 tablet a day to take with up to half a glass of water. Participants must take the tablet first thing in the morning on an empty stomach. After taking the tablet, participants must not eat or drink anything for at least 30 minutes. After the 30 minutes, participants can have their first meal of the day and take any other medicines they may need. The study will last for about 8 months (36 weeks). Participants will have 9 clinic visits and 2 phone calls with the study doctor. At all 9 of the clinic visits, participants will have blood samples taken. At 5 of the clinic visits, participants must arrive fasting. This means they cannot eat for 8 hours before the visit. It is fine to drink water up to 2 hours before the visit. This is for some of the blood samples that will be taken at the visit. Women cannot take part if pregnant, breastfeeding or planning to become pregnant during the study period.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Haemoglobin (HbA1c)

  Change from baseline (week 0) in HbA1c at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  Baseline (Week 0), Week 26

Secondary Outcomes (53)

• Change From Baseline in Body Weight (Kilograms [kg])

  Baseline (Week 0), Week 26

• Change From Baseline in Fasting Plasma Glucose (FPG)

  Baseline (Week 0), Week 26

• Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile

  Baseline (Week 0), Week 26

• Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals)

  Baseline (Week 0), Week 26

• Change From Baseline in Body Weight (Percentage [%])

  Baseline (Week 0), Week 26

Study Arms (4)

Oral semaglutide 3mg

EXPERIMENTAL

Subjects will remain on 3 mg for the entire treatment period (26 weeks)

Drug: Oral semaglutide

Oral semaglutide 7mg

EXPERIMENTAL

Subjects will receive 3 mg for for the first 4 weeks, 7 mg for the remainder of the treatment period

Drug: Oral semaglutide

Oral semaglutide 14mg

EXPERIMENTAL

Subjects will receive 3 mg for the first 4 weeks, 7 mg for the next 4 weeks and 14 mg for the remainder of the treatment period

Drug: Oral semaglutide

Placebo (oral semaglutide)

PLACEBO COMPARATOR

Subjects will receive placebo tablets for the entire treatment period

Drug: Placebo

Interventions

Oral semaglutide DRUG

Tablets to be taken once-daily for 26 weeks

Oral semaglutide 14mg; Oral semaglutide 3mg; Oral semaglutide 7mg

Placebo DRUG

Tablets to be taken once-daily for 26 weeks

Placebo (oral semaglutide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
• Male or female, age above or equal to 18 years at the time of signing informed consent.
• For Algeria only: Male or female, age above or equal to 19 years at the time of signing the informed consent.
• For Taiwan only: Male or female, age above or equal to 20 years at the time of signing the informed consent.
• Diagnosed with type 2 diabetes mellitus
• HbA1c between 7.0 -10.0% (53-86 mmol/mol) (both inclusive).

You may not qualify if:

• \- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an highly effective contraceptive method.
• Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC). Family is defined as a first degree relative.
• History or presence of pancreatitis (acute or chronic).
• History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
• Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening.
• Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
• Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
• Renal impairment measured as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula(CKD-EPI).
• Subjects with alanine aminotransferase (ALT) above 2.5 x upper limit of the normal (ULN).
• Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (66)

Bouzareah Diabetic House Algiers Algeria

Algiers, 16000, Algeria

Location

UH of Douera

Algiers, 16049, Algeria

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230061, China

Location

Beijing Pinggu Hospital

Beijing, Beijing Municipality, 101200, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

Second Affliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, 404000, China

Location

900th Hospital of Joint Logistics Support Force

Fuzhou, Fujian, 350025, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen Universtiy

Guangzhou, Guangdong, 510120, China

Location

The 3rd Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510150, China

Location

Huizhou Central People's Hospital

Huizhou, Guangdong, 516001, China

Location

The 2nd Affiliated Hospital of Shantou Uni Medical College

Shantou, Guangdong, 515065, China

Location

Cangzhou People's Hospital

Cangzhou, Hebei, 061000, China

Location

Handan First Hospital

Handan, Hebei, 056002, China

Location

Harrison International Peace Hospital

Hengshui, Hebei, 053000, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450003, China

Location

Taihe Hospital

Shiyan, Hubei, 442008, China

Location

The First People's Hospital of Changde City

Changde, Hunan, 415003, China

Location

Chenzhou No.1 People's Hospital

Chenzhou, Hunan, 423000, China

Location

Yueyang Central Hospital

Yueyang, Hunan, 414000, China

Location

Changzhou No.2 People's Hospital, Yanghu Branch

Changzhou, Jiangsu, 213003, China

Location

The Second People Hospital of Huai'an

Huai'an, Jiangsu, 223002, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

Nanjing Jiangning Hospital

Nanjing, Jiangsu, 211106, China

Location

Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221002, China

Location

The Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212001, China

Location

The First Hospital of Jiaxing

Jiaxing, Jiangxi, 314001, China

Location

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China

Location

The first hospital of Jilin University

Changchun, Jilin, 130021, China

Location

China-Japan Union Hospital of Jilin University

Changchun, Jilin, 130033, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, 750004, China

Location

Qinghai University Affiliated Hospital

Xining, Qinghai, 810001, China

Location

The second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China

Location

Jinan Central Hospital Affiliated to Shandong University

Jinan, Shandong, 250013, China

Location

The Affiliated Hospital of Jining Medical University

Jining, Shandong, 272029, China

Location

The Affiliated Hospital of Qingdao Medical College

Qingdao, Shandong, 266003, China

Location

Shanghai Pudong New Area People's Hospital

Pudong New District, Shanghai Municipality, 201200, China

Location

Rui Jin Hospital,Shanghai Jiao Tong University School of Med

Shanghai, Shanghai Municipality, 200025, China

Location

Tongji Hospital of Tongji university

Shanghai, Shanghai Municipality, 200065, China

Location

Shanghai Tenth People's Hsopital, Tongji University

Shanghai, Shanghai Municipality, 200072, China

Location

The Fifth People's Hospital of Shanghai

Shanghai, Shanghai Municipality, 200240, China

Location

Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine

Shanghai, Shanghai Municipality, 200336, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610071, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

Location

First Affiated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

The Third Xiangya Hospital of Central South University

Changsha, 410013, China

Location

Szent Margit Rendelőintézet Nonprofit Kft.

Budapest, 1032, Hungary

Location

Kanizsai Dorottya Kórház

Nagykanizsa, 8800, Hungary

Location

Szent Borbála Kórház

Tatabánya, 2800, Hungary

Location

Zala Megyei Szent Rafael Kórház

Zalaegerszeg, 8900, Hungary

Location

Clinical Hospital Center Bezanijska Kosa

Belgrade, 11080, Serbia

Location

Clinical Centre Nis, Endocrinology, Diabetes and Metabolism

Niš, 18000, Serbia

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Chang Gung Medical Foundation - Linko Branch

Taoyuan, 333, Taiwan

Location

Clinic of Medical Academy, Dnipro

Dnipro, 49038, Ukraine

Location

CNI "Khmelnytskyi regional hospital" of KRC

Khmelnytskyi, 29000, Ukraine

Location

Institute of Endocrinology and Metabolism of AMSU

Kyiv, 04114, Ukraine

Location

City Hospital #1

Mykolaiv, 54003, Ukraine

Location

CI "1st City Clinical Hospital of Poltava City Council"

Poltava, 36039, Ukraine

Location

CNI "Ternopil University Clinic" of Ternopil Regio. Council

Ternopil, 46002, Ukraine

Location

Zaporizhia Regional Clinical Endocrinology Dispensary

Zaporizhia, 69600, Ukraine

Location

Related Publications (1)

• Wang W, Bain SC, Bian F, Chen R, Gabery S, Huang S, Jensen TB, Luo B, Yuan G, Ning G; PIONEER 11 investigators. Efficacy and safety of oral semaglutide monotherapy vs placebo in a predominantly Chinese population with type 2 diabetes (PIONEER 11): a double-blind, Phase IIIa, randomised trial. Diabetologia. 2024 Sep;67(9):1783-1799. doi: 10.1007/s00125-024-06142-3. Epub 2024 Jul 10.

  PMID: 38985162 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: September 30, 2019
• Study Start: October 1, 2019
• Primary Completion: September 23, 2021
• Study Completion: October 27, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 14, 2023

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

SE (2); TW (3); UA (7); HU (4); AL (2); CN (48)