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

NCT05444153 | Withdrawn Phase 3 FDA Drug

• 3 other identifiers: NN9924-4668U1111-1270-07632021-005396-39
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Participants acheiving glycated haemoglobin (HbA1c) less than (<) 7 percentage (%) (Yes/No)

  Measured as count of participants.

  At week 104

• Participants acheiving body weight reduction greater than or equal to (>=) 5% (Yes/No)

  Measured as count of participants.

  At week 104

Secondary Outcomes (21)

• Change in HbA1c

  From randomisation (week 0) to week 104

• Change in fasting plasma glucose (FPG)

  From randomisation (week 0) to week 104

• Change in self-measured plasma glucose (SPMG) 7-point mean profile

  From randomisation (week 0) to week 104

• Change in self-measured plasma glucose (SPMG) mean post prandial increments

  From randomisation (week 0) to week 104

• Time to additional anti-diabetic medication

  From randomisation (week 0) to week 104

Study Arms (2)

Oral semaglutide

EXPERIMENTAL

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.

Drug: Semaglutide

Empagliflozin

ACTIVE COMPARATOR

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.

Drug: Empagliflozin

Interventions

Semaglutide DRUG

Participants will receive 1 tablet of oral semaglutide once daily.

Oral semaglutide

Empagliflozin DRUG

Participants will receive 1 tablet of empagliflozin once daily.

Empagliflozin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide; empagliflozin

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: October 6, 2022
• Primary Completion: October 2, 2024
• Study Completion: August 29, 2025
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share