Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2010
End Date:November 2010

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A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: LOW VOLUME)

This trial is conducted in South Africa, Europe and North America. The aim of this trial is
to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine
(IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4
(DPP-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic
drugs (OADs) qualifying for intensified treatment.


Inclusion Criteria:

- Insulin naïve subject (allowed are: previous short term insulin treatment up to 14
days; Treatment during hospitalisation or during gestational diabetes is allowed for
periods longer than 14 days)

- Current treatment: metformin monotherapy or metformin in any combination with an
insulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor,
alpha-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months
prior to visit 1 with the minimum doses stated: -Metformin: alone or in combination
(including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000
mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the daily
maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily
maximal dose according to local labelling - alpha-glucosidase-inhibitors (acarbose):
minimum half of the daily maximal dose or maximum tolerated dose

- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis

- Body Mass Index (BMI) maximum 45.0 kg/m^2

- Type 2 diabetes (diagnosed clinically) for at least 6 months

- Ability and willingness to adhere to the protocol including performance of self
monitored plasma glucose (SMPG) profiles according to the protocol

Exclusion Criteria:

- Use within the last 3 months prior to Visit 1 of: thiazoledinediones (TZDs),
exenatide or liraglutide

- Cardiovascular disease, within the last 6 months prior to Visit 1, defined as:
stroke; decompensated heart failure New York Heart Association (NYHA) class III or
IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass
graft or angioplasty

- Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least
180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)

- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
contraceptive measures according to local requirements [for UK: adequate
contraceptive measures are defined as established use of oral, injected or implanted
hormonal methods of contraception, sterilisation, intrauterine device or intrauterine
system, or consistent use of barrier methods]

- Cancer and medical history of cancer hereof (except basal cell skin cancer or
squamous cell skin cancer)
We found this trial at
53
sites
Minneapolis, Minnesota 55416
548
mi
from
Minneapolis, MN
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Anaheim, California 92801
1157
mi
from
Anaheim, CA
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Asheboro, North Carolina 27203
1006
mi
from
Asheboro, NC
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402
mi
from
Aurora, CO
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Beaver, Pennsylvania 15009
957
mi
from
Beaver, PA
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Billings, Montana 59101
780
mi
from
Billings, MT
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Biloxi, Mississippi 39531
716
mi
from
Biloxi, MS
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Brick, New Jersey 08724
1280
mi
from
Brick, NJ
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Brockton, Massachusetts 02301
1444
mi
from
Brockton, MA
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Brooklyn, New York 11201
1287
mi
from
Brooklyn, NY
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1214
mi
from
Calgary,
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Chapel Hill, North Carolina 27599
1043
mi
from
Chapel Hill, NC
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Charlotte, North Carolina 28204
958
mi
from
Charlotte, NC
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Chicago, Illinois 60607
609
mi
from
Chicago, IL
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Chino, California 91710
1138
mi
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Chino, CA
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Crystal Lake, Illinois 60012
591
mi
from
Crystal Lake, IL
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347
mi
from
Des Moines, IA
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360
mi
from
Desoto, TX
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Evansville, Indiana 47725
561
mi
from
Evansville, IN
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739
mi
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Franklin, OH
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Greenbelt, Maryland 20770
1135
mi
from
Greenbelt, MD
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Greenfield, Indiana 46140
663
mi
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Greenfield, IN
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Greensboro, North Carolina 27408
999
mi
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Greensboro, NC
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Hollywood, Florida 33021
1310
mi
from
Hollywood, FL
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Huntington Beach, California 92646
1162
mi
from
Huntington Beach, CA
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Huntsville, Alabama 35801
661
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Huntsville, AL
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Jacksonville, Florida 32216
1061
mi
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Jacksonville, FL
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458
mi
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Killeen, TX
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Lawrenceville, Georgia 30046
816
mi
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Lawrenceville, GA
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Longwood, Florida 32779
1132
mi
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Longwood, FL
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Melrose Park, Pennsylvania 19027
1227
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Melrose Park, PA
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Milwaukee, Wisconsin 53209
637
mi
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Milwaukee, WI
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Mine Hill, New Jersey 07803
1256
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Mine Hill, NJ
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Mission Hills, California 91345
1175
mi
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Mission Hills, CA
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National City, California 91950
1140
mi
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National City, CA
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New York, New York 10025
1288
mi
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New York, NY
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Norco, California 92860
1133
mi
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Norco, CA
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Norristown, Pennsylvania 19401
1215
mi
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Norristown, PA
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Peak, South Carolina 29122
952
mi
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Peak, SC
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Philadelphia, Pennsylvania 19107
1225
mi
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Philadelphia, PA
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848
mi
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Phoenix, AZ
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Ponte Vedra, Florida 32081
1077
mi
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Ponte Vedra, FL
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Renton, Washington 98057
1402
mi
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Renton, WA
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795
mi
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Roswell, GA
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San Diego, California 92101
1142
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San Diego, CA
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Slidell, Louisiana 70461
691
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Slidell, LA
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Southfield, Michigan 48034
833
mi
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Southfield, MI
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864
mi
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St. George, UT
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St. Louis, Missouri 63117
411
mi
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St. Louis, MO
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Sugar Land, Texas 77478
576
mi
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Sugar Land, TX
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844
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Troy, MI
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828
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Tucson, AZ
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Walnut Creek, California 94598
1319
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Walnut Creek, CA
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