Phase 3 Completed N=530 Randomized Treatment

Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes

Diabetes · Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT01045707 ↗

Enrolled (actual)

530

Serious AEs

8.6%

Results posted

Nov 2015

Primary outcomePrimary: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment — -1.65; -1.72 percentage of glycosylated haemoglobin

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment	-1.65; -1.72	—
PRIMARY Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes	419; 211	—
PRIMARY Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes	19; 53	—
PRIMARY Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)	313; 238; 17; 9; 9; 10	—
SECONDARY Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment	-1.39; -1.34	—
SECONDARY Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26	7.9; 7.9	—

Eligibility Criteria

Inclusion Criteria

For MAIN period (NN5401-3590):
Diagnosis of type 2 diabetes mellitus for at least 6 months
Insulin naïve subjects
Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive)
Body Mass Index (BMI) no higher than 40.0 kg/m^2
For EXTENSION period (NN5401-3726):
Informed consent obtained before any trial-related activities
Must have completed the 26-week treatment period (visit 28) in trial NN5401-3590

Exclusion Criteria

For MAIN period (NN5401-3590):
Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
Cardiovascular disease diagnosed within 6 months before trial start
For EXTENSION period (NN5401-3726):
Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, Monoamine oxidase (MAO) inhibitors
Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01045707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.