Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, 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:January 2010
End Date:October 2010

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A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes (BOOST™ : INTENSIFY BASAL)

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with
insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and
oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the
trial.


Inclusion Criteria:

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

- Treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral
protamine Hagedorn [NPH] insulin) once daily (OD), for at least 3 months

- Ongoing treatment with: metformin with or without other oral antidiabetic drugs
(OADs) for at least 3 months prior to randomisation

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

- BMI maximum 40.0 kg/m^2

Exclusion Criteria:

- Treatment with insulin regimens other than a basal insulin regimen (insulin detemir
or insulin glargine or NPH insulin) OD within 3 months prior to Visit 1

- Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within 3 months
prior to visit 1

- Current rosiglitazone users

- 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)

- Impaired liver function, defined as alanine aminotransferase (ALAT) at least 2.5
times upper limit of normal (one retest analysed at the central laboratory within a
week of receipt of the result is permitted with the result of the last sample being
conclusive)

- 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
23
sites
Minneapolis, Minnesota 55416
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Albany, NY
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Atlanta, GA
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Austin, TX
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Baltimore, Maryland 21287
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Baltimore, MD
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Boynton Beach, Florida 33472
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Boynton Beach, FL
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Clearwater, Florida 33759
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Clearwater, FL
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Dallas, TX
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Des Moines, IA
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Fresno, California 93720
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Fresno, CA
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Hyattsville, Maryland 20782
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Hyattsville, MD
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Jacksonville, Florida 32216
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Jacksonville, FL
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Kissimmee, Florida 34741
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Kissimmee, FL
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Nashua, New Hampshire 03063
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Nashua, NH
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New Port Richey, Florida 34652
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New Port Richey, FL
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Orlando, FL
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Osijek,
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Pembroke Pines, Florida 33027
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Pembroke Pines, FL
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Southfield, Michigan 48034
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Southfield, MI
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Statesville, North Carolina 28625
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Statesville, NC
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Tampa, FL
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Waltham, Massachusetts 02453
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Waltham, MA
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Waterbury, Connecticut 06708
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Waterbury, CT
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