Status:
WITHDRAWN
Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes. This study will look mainly at how well participant's blood sugar and body...
Eligibility Criteria
Inclusion
- Male or female.
- Age ≥18 and \<60 years at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus within 24 months from the day of screening.
- HbA1c of 7.0-10.0% (53-86 millimoles per mole \[mmol/mol\])
- Body mass index ≥25.0 kilogram per square meter (kg/m\^2)
Exclusion
- Treatment with any medication for the indication of diabetes. Prior insulin treatment for gestational diabetes is allowed.
- Treatment with any medication for the indication of weight management 90 days prior to screening.
- Renal impairment measured as estimated glomerular filtration rate (eGFR) \<60 milliliters per minute per 1.73 meter sqaure (mL/min/1.73 m\^2) at screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before 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 \<1.5 nanograms per milliliter (ng/mL) at screening.
- Positive insulinoma associated-protein 2 (IA-2) antibodies ≥7.5 Units/mL or anti-glutamic acid decarboxylase (anti-GAD) antibodies greater than (\>) 5.0 international units per milliliter (IU/mL).
- Impaired liver function, defined as Alanine aminotransferase (ALT) ≥2.5 times or Bilirubin \>1.5 times upper normal limit at screening.
- History of major surgical procedures involving the stomach potentially affecting absorption of trial products (example subtotal or total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
- Presence of clinically significant gastrointestinal disorders affecting absorption of drugs and/or nutrients, as judged by the investigator.
- Any contraindications for empagliflozin or metformin according to local labelling at the investigator's discretion
Key Trial Info
Start Date :
January 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06083675
Start Date
January 26 2024
End Date
May 28 2027
Last Update
February 26 2024
Active Locations (100)
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1
Hillcrest Family Health Center
Waco, Texas, United States, 76708
2
Instituto de Ciências Farmacêuticas
Goiânia, Goiás, Brazil, 74935-330
3
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
4
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, Brazil, 01228-000