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
Idaho Falls, Idaho 83404
1506
mi
from 43215
Idaho Falls, ID
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Chicago, Illinois 60607
275
mi
from 43215
Chicago, IL
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911
mi
from 43215
Dallas, TX
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310
mi
from 43215
Etobicoke,
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Greensboro, North Carolina 27408
318
mi
from 43215
Greensboro, NC
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Jacksonville, Florida 32216
673
mi
from 43215
Jacksonville, FL
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Kingsport, Tennessee 37660
237
mi
from 43215
Kingsport, TN
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Los Angeles, California 90027
1973
mi
from 43215
Los Angeles, CA
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2060
mi
from 43215
Medford, OR
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Milwaukee, Wisconsin 53209
335
mi
from 43215
Milwaukee, WI
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Norfolk, Virginia 23507
421
mi
from 43215
Norfolk, VA
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Redlands, California 92374
1914
mi
from 43215
Redlands, CA
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Renton, Washington 98057
2001
mi
from 43215
Renton, WA
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San Antonio, Texas 78229
1138
mi
from 43215
San Antonio, TX
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Simpsonville, South Carolina 29681
363
mi
from 43215
Simpsonville, SC
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Spring Valley, California 91978
1942
mi
from 43215
Spring Valley, CA
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Springfield, Illinois 62704
352
mi
from 43215
Springfield, IL
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