A research study to compare two doses of semaglutide taken once weekly 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: EUCTR2018-004529-96-BG
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-09
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 964

Inclusion Criteria

- Male or female, age 18 years or older at the time of signing informed consent
- Diagnosed with T2D 180 or more days prior to the day of screening
- Glycated haemoglobin (HbA1c) of 8-10 percent (64-86 mmol/mol) (both inclusive)
- Stable daily dose(s) for 90 days prior to the day of screening of any metformin formulations (1500 mg or more or maximum tolerated or effective dose) alone or in combination with sulfonylureas (SU) (half or more of the maximum approved dose according to local label or maximum tolerated or effective dose)
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 771
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 193

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, as is prior insulin treatment for gestational diabetes
- Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m2 according to Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) creatinine equation as defined by 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