Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 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:August 2008

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A 16 Week Randomised, Open-labelled, Four-armed, Treat-to-target, Parallel-group Trial Comparing SIBA D Once Daily, SIBA E Once Daily, SIBA D Monday, Wednesday and Friday and Insulin Glargine Once Daily, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment

This trial is conducted in Africa, Asia and North America. The aim of this trial is to
compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin
glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.


Inclusion Criteria:

- Informed consent obtained before any trial-related activities. (Trial-related
activities are any procedure that would not have been performed during normal
management of the subject.)

- Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3
months (no previous insulin treatment or previous short term insulin treatment
maximeum 14 days within the last 3 months)

- Treatment with one or two oral anti-diabetic drug (OADs): metformin, sulphonylurea
(SU) (or other insulin secretagogue e.g. repaglinide, nateglinide), alpha-glucosidase
inhibitors for at least 2 months at a stable maximally tolerated dose or at least
half maximally allowed dose according to the summary of product characteristics (SPC)
or locally approved PI

- HbA1c 7.0-11.0 % (both inclusive)

- Body Mass Index (BMI) 23-42 kg/m^2 [lb/in^2 x 703] (both inclusive)

Exclusion Criteria:

- Metformin contraindication according to local practice

- Thiazolidinedione (TZD) treatment within previous three months prior to visit 1

- Any systemic treatment with products which in the Investigator's opinion could
interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) three
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 (except for conditions associated with type 2 diabetes) that, in the opinion
of the Investigator, may confound the results of the trial or pose additional risk in
administering trial drug
We found this trial at
17
sites
Milwaukee, Wisconsin 53209
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Chicago, Illinois 60607
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Chicago, IL
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Dallas, TX
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Etobicoke,
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Greensboro, North Carolina 27408
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Greensboro, NC
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Idaho Falls, Idaho 83404
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Idaho Falls, ID
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Jacksonville, Florida 32216
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Jacksonville, FL
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Kingsport, Tennessee 37660
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Kingsport, TN
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Los Angeles, California 90027
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Los Angeles, CA
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Medford, OR
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Norfolk, Virginia 23507
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Norfolk, VA
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Redlands, California 92374
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Redlands, CA
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Renton, Washington 98057
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Renton, WA
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San Antonio, Texas 78229
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San Antonio, TX
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Simpsonville, South Carolina 29681
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Simpsonville, SC
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Spring Valley, California 91978
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Spring Valley, CA
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Springfield, Illinois 62704
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Springfield, IL
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