Research study to compare three doses of semaglutide tablets taken once daily in people with type 2 diabetes

Phase 1

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2020-000299-39-SI
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-10
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1224

Inclusion Criteria

- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
- HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).
- Body Mass Index (BMI) equal to or above 25 kg/m^2
- Stable daily dose(s) for 90 days prior to the day of screening of: any of the following treatment regimens:
- No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a *:
1. * Metformin (equal to or above 1500 mg or maximum tolerated or effective dose).
2. * Sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose).
3. * Sodium-glucose co-transporter 2 (SGLT2) inhibitors (maximum tolerated dose).
4. Dipeptyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local label).
- Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to terminate DPP-4 inhibitor treatment at randomisation (with no wash-out).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 970
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 254

Exclusion Criteria

- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
- Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified