Research Study to Compare Semaglutide Tablets With Empagliflozin Tablets Taken Once Daily in People With Type 2 Diabetes and Obesity (PIONEER START)

Novo Nordisk

Status and phase: Withdrawn; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Empagliflozin; Drug: Semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05444153

NN9924-4668

2021-005396-39 (EudraCT Number)

U1111-1270-0763 (Other Identifier)

Details and patient eligibility

About

This study compares the medicines semaglutide and empagliflozin in people with newly diagnosed type 2 diabetes and obesity. The study will look mainly at how well the blood sugar and body weight are controlled when participants are taking the study medicine. Participants will either get semaglutide tablets or empagliflozin tablets. Which treatment participants get is decided by chance. Participants will get one tablet per day for 2 years. The study will last for about 2 years and 8 weeks.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, age 18- less than (<) 50 years at the time of signing informed consent.
• Diagnosed with type 2 diabetes mellitus less than or equal to (<=) 365 days from the day of screening.
• Glycated haemoglobin (HbA1c) of 7.0-9.5 percentage (%) (53-80 millimoles per milliliter [mmol/mol]) (both inclusive).
• Body mass index (BMI) greater than or equal to (>=) 30.0 kilograms per meter square (kg/m^2).
• Treatment naïve to any antidiabetic drug(s). However, for a subset of participants (≤25%) any metformin dose or formulations administered is allowed.

Exclusion criteria

• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria since diagnosed with type 2 diabetes mellitus. Prior insulin treatment for gestational diabetes is allowed.
• Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than (<) 60 milliliter per minute per 1.73 meter square (1.7mL/min/1.73 m^2) at screening.
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
• C-peptide less than (<)1.5 nanograms per milliliter (ng/mL) at screening.
• Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
• History of major surgical procedures involving the stomach or small intestine potentially affecting absorption of drugs and/or nutrients.
• Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Oral semaglutide

Experimental group

Description:

Participants will receive once daily oral semaglutide tablet for 104 weeks in a dose escalation fashion of 3milligrams (mg), 7mg, 14 mg and 25 mg once every four weeks during the first 16 weeks and a maintenance dose of 55 mg for the rest 88 weeks.

Treatment:

Drug: Semaglutide

Empagliflozin

Active Comparator group

Description:

Participants will receive once daily empagliflozin tablet for up to 104 weeks, starting with a dose of 10 mg for the first 8 weeks and the maintenance dose of 25 mg for the rest 96 weeks.

Treatment:

Drug: Empagliflozin