Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 1

In brief

This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes. The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.

Key facts

Study ID

NCT00982228

Run by

Novo Nordisk A/S

People needed

629

Starts

2009-09-01

Expected to finish

2010-11-08

Last updated by the study team

2017-04-06

Who can join

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

You may qualify if…

• Type 1 diabetes mellitus for at least 12 months
• Current treatment with any basal bolus insulin for at least 12 months
• HbA1c below or equal to 10.0%
• BMI (Body Mass Index) below or equal to 35.0 kg/m\^2
• For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228)

You may not qualify if…

• Use of any other antidiabetic drug than insulin within the last 3 months
• Cardiovascular disease within the last 6 months
• Uncontrolled treated/untreated severe hypertension
• Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
• Cancer and medical history of cancer

Where it is running

• Novo Nordisk Investigational Site — Huntsville, Alabama, United States
• Novo Nordisk Investigational Site — Peoria, Arizona, United States
• Novo Nordisk Investigational Site — Concord, California, United States
• Novo Nordisk Investigational Site — Fresno, California, United States
• Novo Nordisk Investigational Site — Greenbrae, California, United States
• Novo Nordisk Investigational Site — Huntington Beach, California, United States
• Novo Nordisk Investigational Site — La Mesa, California, United States
• Novo Nordisk Investigational Site — Los Gatos, California, United States
• Novo Nordisk Investigational Site — Santa Barbara, California, United States
• Novo Nordisk Investigational Site — Tustin, California, United States
• Novo Nordisk Investigational Site — Ventura, California, United States
• Novo Nordisk Investigational Site — Walnut Creek, California, United States
• Novo Nordisk Investigational Site — Aurora, Colorado, United States
• Novo Nordisk Investigational Site — Aurora, Colorado, United States
• Novo Nordisk Investigational Site — Hollywood, Florida, United States
• Novo Nordisk Investigational Site — Lake Mary, 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 — Honolulu, Hawaii, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Vincennes, Indiana, United States
• Novo Nordisk Investigational Site — Lexington, Kentucky, United States
• Novo Nordisk Investigational Site — Lexington, Kentucky, United States
• Novo Nordisk Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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