At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years (≥19 in Algeria) at informed consent
- ✓Type 2 diabetes mellitus diagnosis
- ✓On basal insulin for ≥90 days prior to screening
- ✓HbA1c 7.0–10.0% (53–86 mmol/mol) at central lab
- ✕Myocardial infarction, stroke, unstable angina, or transient ischaemic attack within 180 days prior to screening or between screening and randomization
- ✕eGFR <60 ml/min/1.73 m² (renal impairment)
- ✕ALT ≥2.5 times upper normal limit at screening (impaired liver function)
- ✕NYHA Class IV heart failure
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
This Trial is Conducted Globally. The Aim of This Trial is to Compare the Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification.
In Brief
A Phase 3 clinical trial evaluating Insulin degludec/insulin aspart, Insulin glargine, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 532 participants across 71 sites in 7 countries.
Detailed Summary
Trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or without oral antidiabetic treatment in need of treatment intensification.
Study Details
Timeline
Interventions
Administered subcutaneously (s.c. under the skin) once daily.
Administered subcutaneously (s.c. under the skin) once daily.
Administered subcutaneously (s.c. under the skin) once daily.