A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes (PIONEER 11)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: Oral semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04109547

2018-002590-22 (Registry Identifier)

NN9924-4338

U1111-1188-1173 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 521 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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).

Exclusion criteria

• • 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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521 participants in 4 patient groups, including a placebo group

Oral semaglutide 3mg

Experimental group

Description:

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

Treatment:

Drug: Oral semaglutide

Oral semaglutide 7mg

Experimental group

Description:

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

Treatment:

Drug: Oral semaglutide

Oral semaglutide 14mg

Experimental group

Description:

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

Treatment:

Drug: Oral semaglutide

Placebo (oral semaglutide)

Placebo Comparator group

Description:

Subjects will receive placebo tablets for the entire treatment period

Treatment:

Drug: Placebo