A research study to look into how well semaglutide, together with insulin glargine, compares to a higher dose of insulin glargine alone 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
- EUCTR2021-004392-13-PT
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 568
- Diagnosed with T2D mellitus greater than or equal to 180 days before screening.
- HbA1c of 7-9% (53-75 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
- Body mass index (BMI) greater than or equal to 25 kg/m^2 on the day of screening.
- Stable daily dose(s) greater than or equal to 90 days before screening of any of the following anti-diabetic drugs or combination regimens:
- Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose.
- Any metformin combination formulation greater than or equal to 1500 mg or maximum tolerated or effective dose.
The treatment can be with or without SGLT-2 inhibitors.
- Treated with once daily insulin glargine U100 injections less than or equal to 40 units/day greater than or equal to 90 days before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed.
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 324
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 244
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 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.
- Potentially missed diagnosis of Type 1 diabetes (T1D) or latent autoimmune diabetes in adults (LADA) verified by C-peptide less than 0.5 nmol/L (1.5 ng/mL) or antibodies to glutamic acid decarboxylase (anti-GAD) greater than 5 units/mL, as measured by the central laboratory at screening.
- Presence or history(a) of pancreatitis (acute or chronic).
- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 mL/min/1.73 m2 at screening as defined by KDIGO 2012 classification.
- Any episodes(a) of diabetic ketoacidosis within 90 days before screening.
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question.
(a) As declared by the participant or in the medical records
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method