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

Use our guide to learn which trials are right for you!

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
Jacksonville, Florida 32207
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
Austin, Texas 78731
?
mi
from
Austin, TX
Click here to add this to my saved trials
Birmingham, Alabama 35215
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Butte, Montana 59701
?
mi
from
Butte, MT
Click here to add this to my saved trials
?
mi
from
Calgary,
Click here to add this to my saved trials
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Concord, California 94520
?
mi
from
Concord, CA
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Fresno, California 93702
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Honolulu, Hawaii 96814
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Louisville, Kentucky 40213
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
North Dartmouth, Massachusetts 02747
?
mi
from
North Dartmouth, MA
Click here to add this to my saved trials
Plantation, Florida 33324
?
mi
from
Plantation, FL
Click here to add this to my saved trials
Roswell, Georgia 30076
?
mi
from
Roswell, GA
Click here to add this to my saved trials
Round Rock, Texas 78681
?
mi
from
Round Rock, TX
Click here to add this to my saved trials
Wilmington, North Carolina 28401
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
Winchester, Virginia 22601
?
mi
from
Winchester, VA
Click here to add this to my saved trials