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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:January 2008
End Date:June 2008

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Trial Summary
Trial Overview
Inclusion Criteria

A 16 Week Randomised, Open Labelled, 3-armed, Treat-to-target, Parallel Group Trial Comparing SIBA (D) Once Daily + NovoRapid®, SIBA (E) Once Daily + NovoRapid® and Insulin Glargine Once Daily + NovoRapid®, All in a Basal/Bolus Regimen in Subjects With Type 1 Diabetes

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.


Inclusion Criteria:

- Type 1 diabetes for at least one year

- HbA1c 7-11% (both inclusive)

- Treated with insulin for at least six months - any regimen

Exclusion Criteria:

- 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
We found this trial at
7
sites
Novo Nordisk Clinical Trial Call Center
Honolulu, Hawaii 96814
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Honolulu, HI
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Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee 37404
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Chattanooga, TN
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Novo Nordisk Clinical Trial Call Center
Dallas, Texas 75235
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Dallas, TX
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Novo Nordisk Clinical Trial Call Center
Des Moines, Iowa 50314
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Des Moines, IA
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Novo Nordisk Clinical Trial Call Center
Hyattsville, Maryland 20782
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Hyattsville, MD
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Clinical Trial Facility in Miranda
Miranda,
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Miranda,
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Novo Nordisk Clinical Trial Call Center
Renton, Washington 98057
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Renton, WA
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