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

NCT ID: NCT03021187

Last Updated: 2020-03-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

731 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-02

Study Completion Date

2018-08-22

Brief Summary

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This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated with insulin. All subjects should continue their pre-trial insulin therapy (basal, basal-bolus or premixed regimen including combinations of soluble insulins) throughout the trial. Subjects treated with metformin in addition to insulin treatment must continue their metformin treatment throughout the entire trial.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Semaglutide 3 mg

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Oral semaglutide administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment

Semaglutide 3 mg + 7 mg

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Oral semaglutide (3 mg followed by 7 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment

Semaglutide 3 mg + 7 mg + 14 mg

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Oral semaglutide (3 mg followed by 7 mg and finally 14 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Oral semaglutide placebo administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment

Interventions

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semaglutide

Oral semaglutide administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment

Intervention Type DRUG

semaglutide

Oral semaglutide (3 mg followed by 7 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment

Intervention Type DRUG

semaglutide

Oral semaglutide (3 mg followed by 7 mg and finally 14 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment

Intervention Type DRUG

placebo

Oral semaglutide placebo administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - 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 Japan only: Male or female, age above or equal to 20 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus 90 days or more prior to the day of screening. - HbA1c (glycosylated haemoglobin) of 7.0-9.5% (53-80 mmol/mol) (both inclusive). - Stable treatment with one of the following insulin regimens (minimum 10 IU/day) 90 or more days prior to the day of screening.

Exclusion Criteria

Maximum 20% change in total daily dose is acceptable: (1) Basal insulin alone or (2) Basal and bolus insulin in any combination or (3) Premixed insulin including combinations of soluble insulins Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). For Greece only: adequate contraceptive measures are defined as combined hormonal contraception (containing oestrogen and progesterone), which suppress ovulation (oral, intravaginal, percutaneous), progesterone-only hormonal contraception which suppress ovulation (oral, injectable, implantable), intrauterine device, hormone-releasing intrauterine system, bilateral tubal occlusion, partner with vasectomy, sexual abstinence. For Japan only: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives. For Canada only: adequate contraceptive measures are defined as combined hormonal contraception (containing oestrogen and progesterone), which suppress ovulation (oral, intravaginal, percutaneous), progesterone-only hormonal contraception which suppress ovulation (oral, injectable, implantable), intrauterine device, hormone-releasing intrauterine system, bilateral tubal occlusion, partner with vasectomy, sexual abstinence - Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol. - Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC). - History of pancreatitis (acute or chronic). - History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). - Any of the following: myocardial infarction (MI), stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation. - 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 defined as estimated Glomerular Filtration Rate (eGFR) less than 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI). - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term change of insulin treatment for acute illness for a total of 14 days or less. - Known hypoglycaemic unawareness according to Clarke's questionnaire. - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation. - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ). - Subjects with alanine aminotransferase (ALT) more than 2.5 x upper normal limit (UNL).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novo Nordisk Investigational Site

Anniston, Alabama, United States

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Birmingham, Alabama, United States

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Fountain Hills, Arizona, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Fresno, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Riverside, California, United States

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Van Nuys, California, United States

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Vista, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Hialeah, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Franklin, Indiana, United States

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Lexington, Kentucky, United States

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Paducah, Kentucky, United States

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Metairie, Louisiana, United States

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Natchitoches, Louisiana, United States

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Hyattsville, Maryland, United States

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Rockville, Maryland, United States

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Boston, Massachusetts, United States

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Troy, Michigan, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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West Seneca, New York, United States

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Asheville, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Beaver, Pennsylvania, United States

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Lansdale, Pennsylvania, United States

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Summerville, South Carolina, United States

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Chattanooga, Tennessee, United States

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Kingsport, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Mesquite, Texas, United States

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Midland, Texas, United States

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Round Rock, Texas, United States

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Murray, Utah, United States

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Winchester, Virginia, United States

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Winnipeg, Manitoba, Canada

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Moncton, New Brunswick, Canada

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Brampton, Ontario, Canada

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Etobicoke, Ontario, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Waterloo, Ontario, Canada

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Besançon, , France

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Bourgoin, , France

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Brest, , France

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La Roche-sur-Yon, , France

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La Rochelle, , France

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Le Coudray, , France

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Le Creusot, , France

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Narbonne, , France

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Paris, , France

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Saint-Herblain, , France

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Toulouse, , France

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Vénissieux, , France

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Athens, , Greece

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Athens, , Greece

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Ioannina, , Greece

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Larissa, , Greece

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Piraeus, , Greece

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Thessaloniki, , Greece

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Ahmedabad, Gujarat, India

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Bangalore, Karnataka, India

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Kozhikode, Kerala, India

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Indore, Madhya Pradesh, India

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Mumbai, Maharashtra, India

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Mumbai, Maharashtra, India

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Pune, Maharashtra, India

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New Dehli, New Delhi, India

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Jaipur, Rajasthan, India

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Chennai, Tamil Nadu, India

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Kolkata, West Bengal, India

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Kolkata, , India

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Amagasaki-shi, Hyogo, , Japan

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Chuo-ku, Tokyo, , Japan

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Ebina-shi, Kanagawa, , Japan

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Iruma-shi, Saitama, , Japan

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Kanagawa, , Japan

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Kumamoto, , Japan

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Kumamoto-shi, Kumamoto, , Japan

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Miyazaki, , Japan

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Naka, , Japan

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Osaka, , Japan

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Saga-shi, Saga, , Japan

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Sapporo, , Japan

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Shimotsuke-shi, Tochigi, , Japan

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Shizuoka-shi, Shizuoka, , Japan

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Suita-shi, Osaka, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Ube-shi, Yamaguchi, , Japan

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Durango, , Mexico

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San Luis Potosí City, , Mexico

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Bialystok, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Puławy, , Poland

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Manatí, , Puerto Rico

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Kazan', , Russia

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Moscow, , Russia

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Penza, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Countries

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United States Canada France Greece India Japan Mexico Poland Puerto Rico Russia

References

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Zinman B, Aroda VR, Buse JB, Cariou B, Harris SB, Hoff ST, Pedersen KB, Tarp-Johansen MJ, Araki E; PIONEER 8 Investigators. Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial. Diabetes Care. 2019 Dec;42(12):2262-2271. doi: 10.2337/dc19-0898. Epub 2019 Sep 17.

Reference Type RESULT
PMID: 31530667 (View on PubMed)

Pratley RE, Crowley MJ, Gislum M, Hertz CL, Jensen TB, Khunti K, Mosenzon O, Buse JB. Oral Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses. Diabetes Ther. 2021 Apr;12(4):1099-1116. doi: 10.1007/s13300-020-00994-9. Epub 2021 Mar 4.

Reference Type DERIVED
PMID: 33660198 (View on PubMed)

Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

Reference Type DERIVED
PMID: 32998732 (View on PubMed)

Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13.

Reference Type DERIVED
PMID: 32267058 (View on PubMed)

Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

Reference Type DERIVED
PMID: 31903692 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016-000988-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1180-3637

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-173508

Identifier Type: OTHER

Identifier Source: secondary_id

NN9924-4280

Identifier Type: -

Identifier Source: org_study_id

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