Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin



Status:Completed
Conditions:Obesity Weight Loss, Obesity Weight Loss, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:10/28/2018
Start Date:February 6, 2017
End Date:September 25, 2018

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This trial is conducted globally. The aim of this trial is to investigate effect and safety
of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus
treated with basal insulin.


Inclusion Criteria: - Informed consent obtained before any trial-related activities.
Trial-related activities are any procedures that are carried out as part of the trial,
including activities to determine suitability for the trial - Diagnosed with type 2
diabetes mellitus - Treatment with up to 2 OADs (oral anti-diabetic) (metformin, glitazone,
SGLT-2 inhibitor (sodium-glucose cotransporter-2 inhibitors) or sulphonylurea) - Stable
treatment with basal insulin according to its label (no requirement of minimum or maximum
dose) for at least 90 days prior to screening, as judged by the investigator - HbA1c
(glycosylated haemoglobin) 6.0-10.0% (both inclusive) - BMI (body mass index) equal to or
above 27 kg/m^2 - Age at least 18 years at the time of signing informed consent Exclusion
Criteria: - Diagnosis of type 1 diabetes - Known hypoglycaemic unawareness as indicated by
the investigator according to Clarke's questionnaire question 8 (see Section 8.2.3) -
Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator
- Unable or unwilling to perform self-monitoring of plasma glucose according to the
protocol and to keep a diabetes diary - Treatment with any hypoglycaemic medications other
than OADs and basal insulin within the past 90 days prior to screening - Treatment with a
DPP-IV (dipeptidyl peptidase-4) inhibitor within the past 90 days prior to screening -
Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6
months), severe congestive heart failure (NYHA class III, IV), or second degree or greater
heart block - Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple
Endocrine Neoplasia type 2 (MEN2) - Female who is pregnant, breast-feeding or intends to
become pregnant or is of child-bearing potential and not using an adequate contraceptive
method (adequate contraceptive measure as required by local regulation or practice) - For
Germany: Only highly effective methods of birth control are accepted (i.e. one that results
in less than 1% per year failure rate when used consistently and correctly such as
implants, injectables, combined oral contraceptives, some intrauterine device), or sexual
abstinence or vasectomised partner - Use in past 90 days of medications known to induce
significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g.,
chronic use of oral steroids, second generation antipsychotics) - History of pancreatitis
(acute or chronic) - History of major depressive disorder within the past 2 years - Any
lifetime history of a suicide attempt - Inadequately treated blood pressure defined as
Grade 3 hypertension or higher (Systolic above or equal to 180 mmHg or diastolic above or
equal to110 mmHg). - History of malignancy (except for non-melanoma skin cancer) within the
past 5 years
We found this trial at
19
sites
Plantation, Florida 33324
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Plantation, FL
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Albany, New York 12208
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Albany, NY
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Austin, Texas 78731
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Austin, TX
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Birmingham, Alabama 35215
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Birmingham, AL
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Butte, Montana 59701
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Butte, MT
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Calgary,
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Chicago, Illinois 60612
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from
Chicago, IL
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Concord, California 94520
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from
Concord, CA
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Dallas, Texas 75231
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from
Dallas, TX
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Fresno, California 93702
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from
Fresno, CA
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Honolulu, Hawaii 96814
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from
Honolulu, HI
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Jacksonville, Florida 32207
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from
Jacksonville, FL
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Louisville, Kentucky 40213
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from
Louisville, KY
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Minneapolis, Minnesota 55404
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from
Minneapolis, MN
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North Dartmouth, Massachusetts 02747
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from
North Dartmouth, MA
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Roswell, Georgia 30076
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from
Roswell, GA
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Round Rock, Texas 78681
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from
Round Rock, TX
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Wilmington, North Carolina 28401
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from
Wilmington, NC
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Winchester, Virginia 22601
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from
Winchester, VA
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