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
47
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East Providence, Rhode Island 02914
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East Providence, RI
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928
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Arlington, TX
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Asheboro, North Carolina 27203
341
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Asheboro, NC
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Boynton Beach, Florida 33472
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Brentwood, Tennessee 37027
340
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Chattanooga, Tennessee 37404
362
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Chattanooga, TN
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Chicago, Illinois 60607
275
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Chicago, IL
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96
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Cincinnati, OH
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Columbia, South Carolina 29203
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Columbia, SC
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Concord, California 94520
2081
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Concord, CA
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911
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Dallas, TX
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430
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Decatur, GA
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Fort Worth, Texas 76104
937
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Fort Worth, TX
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Greer, South Carolina 29651
350
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Greer, SC
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Humboldt, Tennessee 38343
430
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Humboldt, TN
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913
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Irving, TX
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La Jolla, California 92037
1954
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La Jolla, CA
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Lancaster, California 93534
1950
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Lancaster, CA
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Los Angeles, California 90027
1973
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Los Angeles, CA
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1134
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Lubbock, TX
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Melbourne, Florida 32901
833
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Melbourne, FL
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Melrose Park, Pennsylvania 19027
417
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Metairie, Louisiana 70002
796
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Metairie, LA
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992
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Miami, FL
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Milwaukee, Wisconsin 53209
335
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Milwaukee, WI
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Nashville, Tennessee 37232
334
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National City, California 91950
1949
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New Port Richey, Florida 34652
809
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North East, Maryland 21901
376
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Northport, New York 11768
512
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Northridge, California 91325
1981
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Northridge, CA
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Oklahoma City, Oklahoma 73103
849
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Oklahoma City, OK
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Paducah, Kentucky 42003
361
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Palm Harbor, Florida 34684
821
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Palm Springs, California 92262
1888
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Rockville, Maryland 20852
320
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San Antonio, Texas 78229
1138
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San Antonio, TX
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Slidell, Louisiana 70461
770
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Slidell, LA
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Spring Valley, California 91978
1942
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Spring Valley, CA
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Staten Island, New York 10301
472
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Sugar Land, Texas 77478
1008
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Tarzana, California 91356
1985
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Toms River, New Jersey 08755
466
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Tustin, California 92780
1957
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Upper St. Clair, Pennsylvania 15241
157
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West Palm Beach, Florida 33407
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West Palm Beach, FL
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4608
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Wien,
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