Clinical trial NCT05444153: Research Study to Compare Semaglutide Tablets With Empagliflozin Tablets Taken Once Daily in People With Type 2 Diabetes and Obesity
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-07-05
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Participants acheiving glycated haemoglobin (HbA1c) less than (<) 7 percentage (%) (Yes/No)
timeFrame: At week 104
measure: Participants acheiving body weight reduction greater than or equal to (>=) 5% (Yes/No)
timeFrame: At week 104
Secondary outcomes:
measure: Change in HbA1c
timeFrame: From randomisation (week 0) to week 104
measure: Change in fasting plasma glucose (FPG)
timeFrame: From randomisation (week 0) to week 104
measure: Change in self-measured plasma glucose (SPMG) 7-point mean profile
timeFrame: From randomisation (week 0) to week 104
measure: Change in self-measured plasma glucose (SPMG) mean post prandial increments
timeFrame: From randomisation (week 0) to week 104
measure: Time to additional anti-diabetic medication
timeFrame: From randomisation (week 0) to week 104
measure: Change in body weight
timeFrame: From randomisation (week 0) to week 104
measure: Relative change in body weight
timeFrame: From randomisation (week 0) to week 104
measure: Change in waist circumference
timeFrame: From randomisation (week 0) to week 104
measure: Participants achieving glycated haemoglobin (HbA1c) less than or equal to (<=) 6.5% (Yes/No)
timeFrame: From randomisation (week 0) to week 104
measure: Participants achieving glycated haemoglobin (HbA1c) reduction greater than or equal to (>=) 0.7%-point (Yes/No)
timeFrame: From randomisation (week 0) to week 104
measure: Participants achieving body weight reduction greater than or equal to (>=) 5 percentage (%)
timeFrame: From randomisation (week 0) to week 104
measure: Change in systolic blood pressure
timeFrame: From randomisation (week 0) to week 104
measure: Change in total cholesterol
timeFrame: From randomisation (week 0) to week 104
measure: Change in high density lipoprotein (HDL)
timeFrame: From randomisation (week 0) to week 104
measure: Change in low density lipoprotein (LDL)
timeFrame: From randomisation (week 0) to week 104
measure: Change in very low density lipoprotein (VLDL)
timeFrame: From randomisation (week 0) to week 104
measure: Change in Triglycerides
timeFrame: From randomisation (week 0) to week 104
measure: Change in free fatty acids
timeFrame: From randomisation (week 0) to week 104
measure: Number of treatment emergent adverse events
timeFrame: From randomisation (week 0) to week 109
measure: Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain
timeFrame: From randomisation (week 0) to week 104
measure: Change in Control of Eating Questionnaire (CoEQ) score - Craving for Savory domaina
timeFrame: From randomisation (week 0) to week 104
Other outcomes:
Locations:
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: