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

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01045707

Run by

Novo Nordisk A/S

People needed

530

Starts

2010-01-01

Expected to finish

2010-10-01

Last updated by the study team

2016-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Vestavia Hills, Alabama, United States
• Novo Nordisk Investigational Site — Concord, California, United States
• Novo Nordisk Investigational Site — Greenbrae, California, United States
• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — Waterbury, Connecticut, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — North Miami, Florida, United States
• Novo Nordisk Investigational Site — Pembroke Pines, Florida, United States
• Novo Nordisk Investigational Site — Honolulu, Hawaii, United States
• Novo Nordisk Investigational Site — Honolulu, Hawaii, United States
• Novo Nordisk Investigational Site — Idaho Falls, Idaho, United States
• Novo Nordisk Investigational Site — Council Bluffs, Iowa, United States
• Novo Nordisk Investigational Site — Metairie, Louisiana, United States
• Novo Nordisk Investigational Site — New Orleans, Louisiana, United States
• Novo Nordisk Investigational Site — Detroit, Michigan, United States
• Novo Nordisk Investigational Site — Troy, Michigan, United States
• Novo Nordisk Investigational Site — Saint Charles, Missouri, United States
• Novo Nordisk Investigational Site — Springfield, Missouri, United States
• Novo Nordisk Investigational Site — Brooklyn, New York, United States
• Novo Nordisk Investigational Site — Smithtown, New York, United States
• Novo Nordisk Investigational Site — Greensboro, North Carolina, United States
• Novo Nordisk Investigational Site — Greenville, North Carolina, United States
• Novo Nordisk Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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