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

Diabetes Mellitus, Type 2 Clinical Trial

— PIONEER START  

Official title:

Efficacy and Safety of Early Initiation of Oral Semaglutide 50 mg Once Daily Versus Empagliflozin 25 mg Once Daily in Younger Patients With Newly Diagnosed Type 2 Diabetes and Obesity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05444153
• Other study ID #: NN9924-4668
• Secondary ID: U1111-1270-07632
• Status: Withdrawn
• Phase: Phase 3
• Start date: October 6, 2022
• Est. completion date: August 29, 2025

Study information

• Verified date: November 2022
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 29, 2025
• Est. primary completion date: October 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Semaglutide
Participants will receive 1 tablet of oral semaglutide once daily.
• Empagliflozin
Participants will receive 1 tablet of empagliflozin once daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants acheiving glycated haemoglobin (HbA1c) less than (<) 7 percentage (%) (Yes/No)	Measured as count of participants.	At week 104
Primary	Participants acheiving body weight reduction greater than or equal to (>=) 5% (Yes/No)	Measured as count of participants.	At week 104
Secondary	Change in HbA1c	Measured as percentage (%)-point.	From randomisation (week 0) to week 104
Secondary	Change in fasting plasma glucose (FPG)	Measured in millimoles per liter (mmol/l).	From randomisation (week 0) to week 104
Secondary	Change in self-measured plasma glucose (SPMG) 7-point mean profile	Measured in millimoles per liter(mmol/l).	From randomisation (week 0) to week 104
Secondary	Change in self-measured plasma glucose (SPMG) mean post prandial increments	Measured in millimoles per liter(mmol/l).	From randomisation (week 0) to week 104
Secondary	Time to additional anti-diabetic medication	Measured in days.	From randomisation (week 0) to week 104
Secondary	Change in body weight	Measured in kilograms (kg).	From randomisation (week 0) to week 104
Secondary	Relative change in body weight	Measured as percentage (%).	From randomisation (week 0) to week 104
Secondary	Change in waist circumference	Measured in centimeters (cm).	From randomisation (week 0) to week 104
Secondary	Participants achieving glycated haemoglobin (HbA1c) less than or equal to (<=) 6.5% (Yes/No)	Measured as count of participants.	From randomisation (week 0) to week 104
Secondary	Participants achieving glycated haemoglobin (HbA1c) reduction greater than or equal to (>=) 0.7%-point (Yes/No)	Measured as count of participants.	From randomisation (week 0) to week 104
Secondary	Participants achieving body weight reduction greater than or equal to (>=) 5 percentage (%)	Measured as count of participants.	From randomisation (week 0) to week 104
Secondary	Change in systolic blood pressure	Measured in millimiters of mercury (mmHg).	From randomisation (week 0) to week 104
Secondary	Change in total cholesterol	Measured as ratio to baseline.	From randomisation (week 0) to week 104
Secondary	Change in high density lipoprotein (HDL)	Measured as ratio to baseline.	From randomisation (week 0) to week 104
Secondary	Change in low density lipoprotein (LDL)	Measured as ratio to baseline.	From randomisation (week 0) to week 104
Secondary	Change in very low density lipoprotein (VLDL)	Measured as ratio to baseline.	From randomisation (week 0) to week 104
Secondary	Change in Triglycerides	Measured as ratio to baseline.	From randomisation (week 0) to week 104
Secondary	Change in free fatty acids	Measured as ratio to baseline.	From randomisation (week 0) to week 104
Secondary	Number of treatment emergent adverse events	Measured as count of events.	From randomisation (week 0) to week 109
Secondary	Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain	Measured as score on a scale. Scales range from 0 (minimum) to 10 (maximum).	From randomisation (week 0) to week 104
Secondary	Change in Control of Eating Questionnaire (CoEQ) score - Craving for Savory domaina	Measured as score on a scale. Scales range from 0 (minimum) to 10(maximum).	From randomisation (week 0) to week 104