Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)



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

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A Trial Assessing the Implications of Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™: SIMPLIFY)

This trial is conducted in the United States of America (USA). The aim of this clinical
trial is to assess the implications of switching from insulin glargine (IGlar) to insulin
degludec (IDeg) in subjects with type 2 diabetes mellitus.


Inclusion Criteria:

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

- HbA1c maximum 10 % by central laboratory analysis

- Current treatment with basal-oral therapy (BOT) (no prandial insulin ever) consisting
of: at least three months with insulin glargine once daily (average prescribed dose
must have been unchanged (within plus/minus 10%) for four weeks prior to Visit 1 as
confirmed by patient records or verbal confirmation by the subject) in combination
with stable (unchanged doses for at least 3 months prior to Visit 1) OAD (metformin,
insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor)
treatment in any approved (according to label) dose or combination

Exclusion Criteria:

- Use within the last three months prior to Visit 1 of: Exenatide, Liraglutide or
Thiazoledinediones (TZDs) other than Pioglitazone

- Cardiovascular disease (CVD) 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 within the last six months
prior to Visit 1

- Recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the
last 12 months), or hypoglycaemic unawareness as judged by the Investigator, or
hospitalisation for diabetic ketoacidosis during the previous six months

- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
contraceptive measures according to local requirements

- Previous participation in this trial. Participation is defined as started on trial
medication. Rescreening of screening failures is allowed only once within the limits
of the recruitment period

- Known or suspected hypersensitivity to trial products or related products
We found this trial at
26
sites
Henderson, Nevada 89052
957
mi
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Henderson, NV
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1308
mi
from
Albany, NY
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Anaheim, California 92801
1157
mi
from
Anaheim, CA
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516
mi
from
Austin, TX
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Charlotte, North Carolina 28204
958
mi
from
Charlotte, NC
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Chattanooga, Tennessee 37404
721
mi
from
Chattanooga, TN
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Chicago, Illinois 60607
609
mi
from
Chicago, IL
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Chino, California 91710
1138
mi
from
Chino, CA
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Concord, California 94520
1316
mi
from
Concord, CA
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Dover, New Hampshire 03820
1458
mi
from
Dover, NH
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Fort Worth, Texas 76104
348
mi
from
Fort Worth, TX
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Fresno, California 93720
1205
mi
from
Fresno, CA
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Goodyear, Arizona 85395
868
mi
from
Goodyear, AZ
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Greenbrae, California 94904
1343
mi
from
Greenbrae, CA
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Kingsport, Tennessee 37660
843
mi
from
Kingsport, TN
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Kissimmee, Florida 34741
1149
mi
from
Kissimmee, FL
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Lawrenceville, New Jersey 08648
1247
mi
from
Lawrenceville, NJ
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Melrose Park, Pennsylvania 19027
1227
mi
from
Melrose Park, PA
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Metairie, Louisiana 70002
691
mi
from
Metairie, LA
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Nashua, New Hampshire 03063
1423
mi
from
Nashua, NH
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Olympia, Washington 98502
1422
mi
from
Olympia, WA
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259
mi
from
Omaha, NE
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Palm Springs, California 92262
1082
mi
from
Palm Springs, CA
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848
mi
from
Phoenix, AZ
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Pittsburgh, Pennsylvania 15224
974
mi
from
Pittsburgh, PA
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Toms River, New Jersey 08755
1275
mi
from
Toms River, NJ
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