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
Concord, California 94520
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Concord, CA
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Albany, NY
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Anaheim, California 92801
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Anaheim, CA
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Austin, TX
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Charlotte, North Carolina 28204
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Charlotte, NC
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Chattanooga, Tennessee 37404
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Chattanooga, TN
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Chicago, Illinois 60607
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Chicago, IL
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Chino, California 91710
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Chino, CA
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Dover, New Hampshire 03820
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Dover, NH
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Fort Worth, Texas 76104
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Fort Worth, TX
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Fresno, California 93720
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Fresno, CA
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Goodyear, Arizona 85395
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Goodyear, AZ
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Greenbrae, California 94904
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Greenbrae, CA
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Henderson, Nevada 89052
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Henderson, NV
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Kingsport, Tennessee 37660
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Kingsport, TN
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Kissimmee, Florida 34741
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Kissimmee, FL
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Lawrenceville, New Jersey 08648
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Lawrenceville, NJ
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Melrose Park, Pennsylvania 19027
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Melrose Park, PA
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Metairie, Louisiana 70002
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Metairie, LA
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Nashua, New Hampshire 03063
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Nashua, NH
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Olympia, Washington 98502
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Olympia, WA
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Omaha, NE
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Palm Springs, California 92262
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Palm Springs, CA
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Phoenix, AZ
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Pittsburgh, Pennsylvania 15224
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Pittsburgh, PA
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Toms River, New Jersey 08755
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Toms River, NJ
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