Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin



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

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A Trial Comparing Efficacy and Safety of NN1250 With Sitagliptin in Insulin Naive Subjects With Type 2 Diabetes (BEGIN™ : EARLY)

This trial will be conducted in Africa, Asia, North America and South America. The aim of
this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to
subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes
inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).


Inclusion Criteria:

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

- Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue
(sulphonylurea or glinides) or pioglitazone) in any combination 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 or maximum tolerated
dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide):
minimum half of the maximal daily dose according to local labelling -Pioglitazone:
minimum half of the maximal daily dose according to local labelling or maximum
tolerated dose

- Body Mass Index (BMI) below or equal to 40.0 kg/m^2

- HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis

Exclusion Criteria:

- Use within the last 3 months prior to Visit 1 of: exenatide, liraglutide,
rosiglitazone or acarbose

- 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)

- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the
last 12 months) or hypoglycaemic unawareness as judged by the Investigator or
hospitalisation for diabetic ketoacidosis during the previous 6 months

- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate

- Cancer and medical history hereof (except basal cell skin cancer or squamous cell
skin cancer)
We found this trial at
43
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Albuquerque, New Mexico 87102
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Charleston, South Carolina 29425
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Chicago, Illinois 60607
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Clearwater, Florida 33759
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Concord, California 94520
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Corpus Christi, Texas 78404
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Council Bluffs, Iowa 51501
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Fresno, California 93720
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Greenbrae, California 94904
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Huntington, Indiana 46750
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Huntsville, Alabama 35801
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Inverness, Florida 34452
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Jackson, Mississippi 39216
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Kissimmee, Florida 34741
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La Jolla, California 92037
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Livonia, Michigan 48152
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Metairie, Louisiana 70002
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Mission Hills, California 91345
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Oklahoma City, Oklahoma 73103
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Paducah, Kentucky 42003
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Palm Springs, California 92262
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Pittsburgh, Pennsylvania 15224
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Spokane, Washington 99204
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Springfield, Illinois 62704
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Sugar Land, Texas 77478
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