Comparison of NN1250 With Insulin Glargine in Type 1 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:May 2011

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A 26-week Trial Investigating the Dosing Flexibility, Efficacy and Safety of NN1250 in Subjects With Type 1 Diabetes With a 26-week Extension (Begin™: Flex T1)

This trial is conducted in Europe and in the United States of America (USA). The aim of this
trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects
with type 1 diabetes.


Inclusion Criteria:

- Type 1 diabetes for 12 months or longer, hereof the last 3 months with injection
based therapies

- Current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, NPH
insulin) using one or two daily injections and with three or more daily meal-time
insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human
insulin) used as bolus insulin therapy

- HbA1c maximum 10.0 % by central laboratory analysis

- Body Mass Index (BMI) below or equal to 35.0 kg/m^2

- Ability to self-manage insulin therapy as assessed by confirmation (verbal
confirmation at screening visit) of a changed insulin dose in the preceding two
months prior to screening

- Ability and willingness to adhere to the protocol including performance of self
measured plasma glucose (SMPG) profiles and self adjustment of insulin doses

Exclusion Criteria:

- Use within the last 3 months prior to Visit 1 of any antidiabetic glucose lowering
drug other than insulin

- 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 above or
equal to 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure above or
equal to 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 (except basal cell skin cancer or squamous cell
skin cancer)
We found this trial at
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Chapel Hill, North Carolina 27599
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Fresno, California 93720
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Greenville, North Carolina 27834
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Greer, South Carolina 29651
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Hollywood, Florida 33021
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