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
Sugar Land, Texas 77478
1619
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Sugar Land, TX
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Anaheim, California 92801
2580
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Anaheim, CA
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Asheboro, North Carolina 27203
653
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Asheboro, NC
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1755
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Aurora, CO
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Beaver, Pennsylvania 15009
489
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Beaver, PA
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Billings, Montana 59101
1854
mi
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Billings, MT
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Biloxi, Mississippi 39531
1287
mi
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Biloxi, MS
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Brick, New Jersey 08724
221
mi
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Brick, NJ
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Brockton, Massachusetts 02301
20
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Brockton, MA
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Brooklyn, New York 11201
188
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Brooklyn, NY
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2089
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Calgary,
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Chapel Hill, North Carolina 27599
616
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Chapel Hill, NC
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Charlotte, North Carolina 28204
719
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Charlotte, NC
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Chicago, Illinois 60607
847
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Chicago, IL
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Chino, California 91710
2560
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Chino, CA
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Crystal Lake, Illinois 60012
877
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Crystal Lake, IL
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1154
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Des Moines, IA
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1556
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Desoto, TX
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Evansville, Indiana 47725
912
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Evansville, IN
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714
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Franklin, OH
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Greenbelt, Maryland 20770
381
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Greenbelt, MD
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Greenfield, Indiana 46140
783
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Greenfield, IN
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Greensboro, North Carolina 27408
635
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Greensboro, NC
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Hollywood, Florida 33021
1240
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Hollywood, FL
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Huntington Beach, California 92646
2586
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Huntsville, Alabama 35801
984
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Huntsville, AL
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Jacksonville, Florida 32216
1015
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Jacksonville, FL
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1656
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Killeen, TX
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Lawrenceville, Georgia 30046
907
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Lawrenceville, GA
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Longwood, Florida 32779
1105
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Longwood, FL
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Melrose Park, Pennsylvania 19027
262
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Melrose Park, PA
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Milwaukee, Wisconsin 53209
854
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Milwaukee, WI
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Mine Hill, New Jersey 07803
207
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Mine Hill, NJ
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Minneapolis, Minnesota 55416
1122
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Minneapolis, MN
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Mission Hills, California 91345
2592
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Mission Hills, CA
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National City, California 91950
2574
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National City, CA
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New York, New York 10025
183
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New York, NY
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Norco, California 92860
2556
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Norco, CA
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Norristown, Pennsylvania 19401
269
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Norristown, PA
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Peak, South Carolina 29122
787
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Peak, SC
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Philadelphia, Pennsylvania 19107
268
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Philadelphia, PA
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2288
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Phoenix, AZ
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Ponte Vedra, Florida 32081
1022
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Ponte Vedra, FL
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Renton, Washington 98057
2479
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Renton, WA
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917
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Roswell, GA
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San Diego, California 92101
2576
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Slidell, Louisiana 70461
1328
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Southfield, Michigan 48034
620
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2261
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St. George, UT
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St. Louis, Missouri 63117
1040
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611
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Troy, MI
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2269
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Tucson, AZ
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Walnut Creek, California 94598
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