The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 80
Updated:3/30/2013
Start Date:September 2012
End Date:September 2013
Contact:Novo Nordisk
Email:clinicaltrials@novonordisk.com

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This trial is conducted in Asia, Europe and North and South America. The aim of the trial is
to investigate the effect of liraglutide versus placebo when added to basal insulin
analogues with or without metformin in subjects with type 2 diabetes.


Inclusion Criteria:

- Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated
with stable basal insulin analogue dose of minimum 20 U/day with or without stable
metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening
(defined as insulin adjustments less than 10% during the past 8 weeks as assessed by
the investigator)

- HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive)

- Body mass index (BMI) 20-45 kg/m^2 (both inclusive)

Exclusion Criteria:

- Female of child-bearing potential who is pregnant, breast-feeding or intending to
become pregnant

- Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness

- Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria
in a period of 12 weeks prior to screening

- Impaired liver or renal function

- Uncontrolled treated or untreated hypertension (systolic blood pressure (SBP) equal
to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100
mmHg)

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

- Known or suspected abuse of alcohol or narcotics
We found this trial at
19
sites
Hyattsville, Maryland 20782
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Hyattsville, MD
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Arlington, Virginia 22201
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Arlington, VA
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Atlanta, GA
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Baton Rouge, Louisiana 70808
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Baton Rouge, LA
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Charleston, South Carolina 29425
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Charleston, SC
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Chicago, Illinois 60607
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Chicago, IL
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Erlanger, Kentucky 41018
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Erlanger, KY
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Fort Worth, Texas 76104
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Fort Worth, TX
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Indianapolis, Indiana 46260
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Indianapolis, IN
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Lebanon, New Hampshire 03756
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Lebanon, NH
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Long Beach, California 90806
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Long Beach, CA
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Martinsburg, West Virginia 25401
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Martinsburg, WV
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Memphis, Tennessee 38163
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Memphis, TN
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Morehead City, North Carolina 28557
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Morehead City, NC
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North Dartmouth, Massachusetts 02747
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North Dartmouth, MA
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Omaha, NE
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Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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Salt Lake City, Utah 84107
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Salt Lake City, UT
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Spokane, Washington 99204
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Spokane, WA
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