Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 1

In brief

This trial is conducted in Europe, Oceania, and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart. The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.

Key facts

Study ID

NCT00978627

Run by

Novo Nordisk A/S

People needed

548

Starts

2009-08-01

Expected to finish

2010-05-01

Last updated by the study team

2017-03-20

Who can join

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

You may qualify if…

• FOR THE MAIN TRIAL, NN5401-3594:
• Type 1 diabetes mellitus for at least 12 months
• Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months
• HbA1c 7.0-10.0% (both inclusive)
• BMI (Body Mass Index) below or equal to 35.0 kg/m\^2
• FOR THE EXTENSION TRIAL, NN5401-3645:
• The subject must have completed the six-month treatment period in trial NN5401-3594

You may not qualify if…

• FOR THE MAIN TRIAL, NN5401-3594:
• Treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months
• Cardiovascular disease within the last 6 months
• Uncontrolled treated/untreated severe hypertension
• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
• Cancer and medical history of cancer
• FOR THE EXTENSION TRIAL, NN5401-3645:
• Anticipated significant lifestyle changes during the trial
• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures

Where it is running

• Novo Nordisk Investigational Site — Lancaster, California, United States
• Novo Nordisk Investigational Site — Mission Hills, California, United States
• Novo Nordisk Investigational Site — North Hollywood, California, United States
• Novo Nordisk Investigational Site — Salinas, California, United States
• Novo Nordisk Investigational Site — Valencia, California, United States
• Novo Nordisk Investigational Site — Aurora, Colorado, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Lawrenceville, Georgia, United States
• Novo Nordisk Investigational Site — Roswell, Georgia, United States
• Novo Nordisk Investigational Site — Honolulu, Hawaii, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Shawnee Mission, Kansas, United States
• Novo Nordisk Investigational Site — Lexington, Kentucky, United States
• Novo Nordisk Investigational Site — Eagan, Minnesota, United States
• Novo Nordisk Investigational Site — Minneapolis, Minnesota, United States
• Novo Nordisk Investigational Site — City of Saint Peters, Missouri, United States
• Novo Nordisk Investigational Site — Butte, Montana, United States
• Novo Nordisk Investigational Site — Omaha, Nebraska, United States
• Novo Nordisk Investigational Site — Henderson, Nevada, United States
• Novo Nordisk Investigational Site — Albany, New York, United States
• Novo Nordisk Investigational Site — Northport, New York, United States
• Novo Nordisk Investigational Site — Morehead City, North Carolina, United States
• Novo Nordisk Investigational Site — La Mesa, California, United States

Full record on ClinicalTrials.gov

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