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:December 2010

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A 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of Insulin naïve Subjects With Type 2 Diabetes Mellitus Currently Treated With OADs Qualifying for Intensified Treatment (BEGIN™: EASY™)

This trial was conducted in Europe and North America. The aim of this clinical trial was to
compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with
insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or
DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with
oral anti-diabetic drugs (OADs).


Inclusion Criteria:

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

- Insulin naïve subjects (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 insulin
secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor,
alpha-glucosidase-inhibitor (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 (SU) 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-inhibitor
(acarbose): minimum half of the daily maximal dose or maximum tolerated dose

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

- BMI (Body Mass Index) below or equal to 45.0 kg/m^2

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

- Cancer and medical history of cancer hereof (except basal cell skin cancer or
squamous cell skin cancer)
We found this trial at
49
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Dunwoody, Georgia 30338
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Altoona, Pennsylvania 16602
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Arlington, TX
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Arlington Heights, Illinois 60005
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Austin, TX
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Birmingham, Alabama 35205
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Boynton Beach, Florida 33472
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Burlington, North Carolina 27215
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Chattanooga, Tennessee 37404
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Chicago, Illinois 60607
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Chicago, IL
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Crestview Hills, Kentucky 41017
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Dallas, TX
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Dayton, OH
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DeLand, FL
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Denver, CO
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Eagan, MN
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Escondido, California 92026
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Escondido, CA
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Glen Burnie, Maryland 21061
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Golden, CO
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Harrisburg, Pennsylvania 17112
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Houston, TX
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Kingsport, Tennessee 37660
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La Jolla, California 92037
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Los Angeles, California 90027
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Los Banos, California 93635
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Madisonville, Kentucky 42431
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Metairie, Louisiana 70002
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Monterey, California 93940
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Ogden, UT
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Orange Park, Florida 32073
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Palm Springs, California 92262
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Pasadena, California 91105
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Peoria, AZ
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Plantation, Florida 33324
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Redondo Beach, California 90277
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Reisterstown, Maryland 21136
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San Mateo, California 94401
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Seattle, Washington 98122
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Spokane, Washington 99204
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Staten Island, New York 10301
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Tarzana, California 91356
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Tustin, California 92780
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West Palm Beach, Florida 33407
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