A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2013
End Date:May 2014

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A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™: ONCE)

This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the
trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin
naïve subjects with type 2 diabetes.


Inclusion Criteria:

- Type 2 diabetes mellitus (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 an
insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV)
inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least
3 months prior to randomisation (Visit 2) 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 or
glinide): minimum half of the daily maximal dose according to local labelling, DPP-IV
inhibitor: minimum 100 mg daily or according to local labelling,
alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or
maximum tolerated dose

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

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

Exclusion Criteria:

- Treatment with TZDs (thiazoledinedione), or GLP-1 (glucagon-like peptide 1) receptor
agonists within the last 3 months prior to Visit 1 (screening)

- Anticipated change in concomitant medication known to interfere significantly with
glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (monoamine
oxidase) inhibitors

- Cardiovascular disease within the last 6 months prior to Visit 1 (screening) defined
as stroke; decompensated heart failure NYHA (New York Heart Association) class III or
IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass
graft or angioplasty

- Any clinically significant disease or disorder, except for conditions associated with
type 2 diabetes mellitus, which in the Investigator's opinion could interfere with
the results of the trial

- Previous participation in this trial. Participation is defined as randomised.
Re-screening of screening failures is allowed only once within the limits of the
recruitment period

- Known or suspected hypersensitivity to trial product(s) or related products
We found this trial at
12
sites
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São Paulo,
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Anaheim, California 92801
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from
Anaheim, CA
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Chicago, Illinois 60607
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mi
from
Chicago, IL
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Crestview Hills, Kentucky 41017
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mi
from
Crestview Hills, KY
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mi
from
Dallas, TX
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Kenosha, Wisconsin 53142
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mi
from
Kenosha, WI
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Lomita, California 90717
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mi
from
Lomita, CA
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Los Angeles, California 90027
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mi
from
Los Angeles, CA
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Norfolk, Virginia 23507
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mi
from
Norfolk, VA
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Smithtown, New York 11787
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mi
from
Smithtown, NY
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Toms River, New Jersey 08755
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mi
from
Toms River, NJ
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?
mi
from
Troy, MI
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