Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2011
End Date:July 2012

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A Trial Comparing the Efficacy and Safety of Adding Liraglutide Versus Addition of Insulin Aspart With the Largest Meal to Insulin Degludec, Both in Combination With Metformin, in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification (BEGIN™: VICTOZA® ADD-ON)

This trial is conducted in Europe and North America. The aim of this trial is to compare the
efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest
meal to insulin degludec in subjects with type 2 diabetes.

Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643
(NCT01193309) trial will be randomised to receive treatment intensification while subjects
with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to
receive insulin degludec treatment. Subjects are to continue their pre-trial metformin
treatment.


Inclusion Criteria:

- Informed consent obtained before any trial-related activities. (Trial-related
activities are any procedure that would not have been performed during normal
management of the subject).

- The subject must have completed the end of treatment visit of NN1250-3643 with
Insulin degludec once daily + metformin.

- Ability and willingness to adhere to the protocol including self measurement of
plasma glucose according to the protocol

Exclusion Criteria:

- Participated in NN1250-3643 and treated with insulin glargine

- Previous treatment with glucacon like peptide (GLP-1) receptor agonists (e.g.
exenatide, liraglutide)

- Impaired liver function, defined as alanine aminotransferase (ALAT) 2.5 times the
upper limit of normal at end of treatment in NN1250-3643

- Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for
males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for
metformin [For France: glomerular filtration rate below 60 ml/min, calculated by the
Cockroft & Gault formula] at end of treatment in NN1250-3643.
We found this trial at
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Northport, New York 11768
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