NN5401-3590: A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™ : START 1) / NN5401-3726: An Extension Trial Comparing Safety and Efficacy of NN5401 With Insulin Glargine in Subjects With Type 2 Diabetes (BOOST™: START 1)
Abstract
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug).
The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.
Conditions: Diabetes, Diabetes Mellitus, Type 2.
Primary outcome: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment; Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes; Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes; Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs).
Enrollment: 530 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 530 participants or records.
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