A Research Study to Compare Two Semaglutide Medicines in People with Type 2 Diabetes
- Conditions
- Diabetes mellitus, Type 2MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2021-001501-69-SK
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 380
1. Diagnosed with T2D mellitus equal to or greater than 180 days before screening.
2. Stable daily dose(s) equal to or greater than 90 days prior to the day of screening of metformin equal to or greater than 1500 mg or maximum tolerated or effective dose.
3. HbA1c of 7.0-10.5% (53-91.3 mmol/mol) (both inclusive).
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 380
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Known or suspected hypersensitivity to study interventions or related products.
2. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed.
3. 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 nondilated examination.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish non-inferiority of semaglutide J s.c. against semaglutide B s.c. on change from baseline in HbA1c at week 28 in participants with<br>T2D as add-on to stable dose of metformin.;Secondary Objective: - To compare the effect of semaglutide J s.c. and semaglutide B s.c. on change from baseline in body weight at week 28 in participants with T2D as add-on to stable dose of metformin<br><br>- To compare the number of treatment AEs between semaglutide J s.c. and semaglutide B s.c. in participants with T2D as add-on to stable dose of metformin<br><br>- To compare the development of anti semaglutide antibodies between semaglutide J s.c. and semaglutide B s.c. in participants with T2D as add on to stable dose of metformin;Primary end point(s): 1. Change in HbA1c;Timepoint(s) of evaluation of this end point: 1. From baseline visit (visit 2; week 0) to end of treatment visit (visit 10; week 28)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change in body weight<br>2. Number of treatment emergent AEs<br>3. Occurrence of anti-semaglutide antibodies (yes/no)<br>- In vitro neutralising anti semaglutide antibodies<br>- Anti-semaglutide binding antibodies cross reacting with endogenous GLP-1<br>- In vitro neutralising cross reacting antibodies to endogenous GLP-1<br>4. Anti-semaglutide antibodies level;Timepoint(s) of evaluation of this end point: 1. From baseline visit (visit 2; week 0) to end of treatment visit (visit 10; week 28)<br>2. From the time of first dosing to end of study visit (visit 11; week 33)<br>3.-4. From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)