Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes

Completed · Phase 2

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 trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.

Key facts

Study ID

NCT00612040

Run by

Novo Nordisk A/S

People needed

178

Starts

2008-01-01

Expected to finish

2008-06-01

Last updated by the study team

2017-03-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 diabetes for at least one year
• HbA1c 7-11% (both inclusive)
• Treated with insulin for at least six months - any regimen

You may not qualify if…

• Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (eg systemic corticosteroids) 3 months prior to randomisation
• Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial product

Where it is running

• Novo Nordisk Investigational Site — Walnut Creek, California, United States
• Novo Nordisk Investigational Site — Honolulu, Hawaii, United States
• Novo Nordisk Investigational Site — Idaho Falls, Idaho, United States
• Novo Nordisk Investigational Site — Des Moines, Iowa, United States
• Novo Nordisk Investigational Site — Hyattsville, Maryland, United States
• Novo Nordisk Investigational Site — Chattanooga, Tennessee, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Renton, Washington, United States
• Novo Nordisk Investigational Site — Wollongong, New South Wales, Australia
• Novo Nordisk Investigational Site — Keswick, South Australia, Australia
• Novo Nordisk Investigational Site — East Ringwood, Victoria, Australia
• Novo Nordisk Investigational Site — Geelong, Australia
• Novo Nordisk Investigational Site — Miranda, Australia
• Novo Nordisk Investigational Site — Aschaffenburg, Germany
• Novo Nordisk Investigational Site — Bad Kreuznach, Germany
• Novo Nordisk Investigational Site — Dresden, Germany
• Novo Nordisk Investigational Site — Hamburg, Germany
• Novo Nordisk Investigational Site — Hohenmölsen, Germany
• Novo Nordisk Investigational Site — Neuwied, Germany
• Novo Nordisk Investigational Site — Saint Ingbert, Germany
• Novo Nordisk Investigational Site — Bergen, Norway
• Novo Nordisk Investigational Site — Bergen, Norway
• Novo Nordisk Investigational Site — Elverum, Norway
• Novo Nordisk Investigational Site — Kristiansand, Norway

Full record on ClinicalTrials.gov

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