A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted globally. The aim of the trial is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an extension to trial NN5401-3941 (NCT01680341).

Key facts

Study ID

NCT01814137

Run by

Novo Nordisk A/S

People needed

40

Starts

2013-03-01

Expected to finish

2014-03-01

Last updated by the study team

2017-03-21

Who can join

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

You may qualify if…

• HbA1c equal to or above 7.0% measured after 26 weeks of treatment in NN5401-3941 (NCT01680341), by central laboratory

You may not qualify if…

• Uncontrolled or untreated severe hypertension defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg
• Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) equal to or above 2.5 times upper limit of normal
• Impaired renal function defined as serum-creatinine equal to or above 125 micromol/L (equal to or above 1.4 mg/dL) for males and equal to or above 110 micromol/L (equal to or above 1.3 mg/dL) for females

Where it is running

• Novo Nordisk Investigational Site — Goodyear, Arizona, United States
• Novo Nordisk Investigational Site — Phoenix, Arizona, United States
• Novo Nordisk Investigational Site — Anaheim, California, United States
• Novo Nordisk Investigational Site — Greenbrae, California, United States
• Novo Nordisk Investigational Site — San Diego, California, United States
• Novo Nordisk Investigational Site — Spring Valley, California, United States
• Novo Nordisk Investigational Site — Bradenton, Florida, United States
• Novo Nordisk Investigational Site — Kissimmee, Florida, United States
• Novo Nordisk Investigational Site — Plantation, Florida, United States
• Novo Nordisk Investigational Site — Avon, Illinois, United States
• Novo Nordisk Investigational Site — Crystal Lake, Illinois, United States
• Novo Nordisk Investigational Site — Indianapolis, Indiana, United States
• Novo Nordisk Investigational Site — Slidell, Louisiana, United States
• Novo Nordisk Investigational Site — Waltham, Massachusetts, United States
• Novo Nordisk Investigational Site — Buckley, Michigan, United States
• Novo Nordisk Investigational Site — Nashua, New Hampshire, United States
• Novo Nordisk Investigational Site — Lawrenceville, New Jersey, United States
• Novo Nordisk Investigational Site — Toms River, New Jersey, United States
• Novo Nordisk Investigational Site — Albany, New York, United States
• Novo Nordisk Investigational Site — Myrtle Beach, South Carolina, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Fort Worth, Texas, United States
• Novo Nordisk Investigational Site — Olympia, Washington, United States
• Novo Nordisk Investigational Site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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