Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity
Status: | Active, not recruiting |
---|---|
Conditions: | Obesity Weight Loss, Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/9/2019 |
Start Date: | June 4, 2018 |
End Date: | May 4, 2020 |
Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity and Type 2 Diabetes
This study will look at the change in the participant's body weight from the start to the end
of the study. This is to compare the effect on body weight in people taking semaglutide (a
new medicine) and people taking "dummy" medicine. In addition to taking the study medicine,
the participant will have talks with study staff about healthy food choices, how to be more
physically active and what else the participant can do to lose weight. Overweight and obesity
is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to
have a beneficial impact on the blood sugar levels. The participant will either get
semaglutide or "dummy" medicine - which treatment the participant get is decided by chance.
The participant will need to take 2 injections at the same time once a week. The study
medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm.
The study will last for about 1.5 years
of the study. This is to compare the effect on body weight in people taking semaglutide (a
new medicine) and people taking "dummy" medicine. In addition to taking the study medicine,
the participant will have talks with study staff about healthy food choices, how to be more
physically active and what else the participant can do to lose weight. Overweight and obesity
is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to
have a beneficial impact on the blood sugar levels. The participant will either get
semaglutide or "dummy" medicine - which treatment the participant get is decided by chance.
The participant will need to take 2 injections at the same time once a week. The study
medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm.
The study will last for about 1.5 years
Inclusion Criteria:
- Male or female, age greater than or equal to 18 years at the time of signing informed
consent
- Body Mass Index (BMI) greater than or equal to 27 kg/m^2 '
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- Diagnosed with type 2 diabetes (haemoglobin A1c 7-10% (53-86 mmol/mol) (both
inclusive)) 180 days or longer prior to the day of screening
Exclusion Criteria:
- A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before
screening irrespective of medical records
- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less
than 30 mL/min/1.73 m^2 (less than 60 ml/min/1.73 m^2 in subjects treated with
Sodium-glucose Cotransporter 2 Inhibitors) according to chronic kidney disease
(CKD)-Epidemiology Collaboration (EPI) creatinine equation as defined by Kidney
Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by
a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist
or an equally qualified health care provider (e.g. optometrist) within the past 90
days prior to screening or in the period between screening and randomisation
We found this trial at
45
sites
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