Type 2 diabetes mellitus
Conditions
Interventions
Participants with T2D inadequately controlled on once-daily basal insulin with or without metformin will be randomised to receive either:
- CagriSema 2.4 mg/2.4 mg
- Placebo 2.4 mg/2.4 mg
- CagriSema
Sponsors
Kanda Yuhei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosed with type 2 diabetes mellitus >= 180 days before screening. - On stable once-daily dose of basal insulin (minimum of 0.25 U/kg/day or 20 U/day) alone or in combination with metformin (at effective or maximum tolerated dose as judged by the investigator) for 90 days prior to screening. - HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening. - BMI >=25 kg+E62m2 at screening. BMI will be calculated in the eCRF based on height and body weight at screening.
Exclusion criteria
Exclusion criteria: - Renal impairment with estimated Glomerular Filtration Rate < 30 ml/min/1.73 m2 as determined by central laboratory at screening. - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. - Known hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8. - Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline (week 0) to end of treatment (week 40) | — |
Countries
China, Japan, Serbia, Slovakia, South Africa, United States
Contacts
Public ContactAdministorator Clinical trail information
Novo Nordisk Pharma Ltd.
Outcome results
None listed