Type 2 Diabetes and Body Weight Clinical Trial NCT03005288
Novartis Pharmaceuticals is sponsoring a clinical research trial for overweight or obese men and women between the ages of 18-75 years old, living with type 2 diabetes. Patients who are eligible for this trial must be diagnosed with type 2 diabetes and must have a body mass index (BMI) between 28 to 40 kg/m2.
The purpose of this study is to compare the body fat of patients who will be taking the study drug with the body fat of patients who will be taking the placebo (a dummy substance, that has no therapeutic effect, used as a control in testing new drugs).
The study drug, called bimagrumab (BYM338), will be tested to determine its ability to promote fat loss while also preserving or building total muscle mass. Total body fat mass and the overall effects that the study drug has on type 2 diabetes will be evaluated after 24 weeks and 48 weeks.
Patients that qualify and agree to participate will be provided with professional dietary counseling and will participate in an American Diabetes Association (ADA) walking program. Patients in this study will also be required to attend study visits to complete assessments and receive an intravenous infusion of either the study drug or placebo once every four weeks for a total of 12 doses and a total of 48 weeks.
To find out more about type 2 diabetes click here.
To see if you may be eligible, click here for a prescreener/questionaire.
Find out if there is a clinical study location nearby.
Patients who wish to participate in this trial must meet the following requirements:
- Must be a between the ages of 18-75 years old
- Must be overweight or obese with a weight between 65 and 140 kg (143 and 310 lbs) and BMI between 28 - 40 kg/m2
- Must be in a stable health condition with a diagnosis of type 2 diabetes
- Must not be pregnant or nursing
- Must not have a history of drug or alcohol abuse within the past 12 months
Patients who are eligible and decide to enroll in this trial:
- Will undergo an onsite screening visit to determine their eligibility for the study
- Will be instructed to follow a diet containing approximately 45-50% of calories as carbohydrates, 20-25% of calories as protein, and 30% of calories as fat, and will be required to provide information on their food intake throughout the study
- Will receive counseling for physical activity, and will be encouraged to follow the ADA walking program guidelines
- Will randomly receive either study drug or the placebo via a monthly intravenous infusion over 30 minutes, followed by a short observation period
- Will be asked to return to the study site approximately once every four weeks during the treatment period
- Will be asked to return to the site for a follow-up and end of treatment visit
- Will not be charged to participate
- Will receive compensation for time and travel costs
- May withdraw from the trial at any time, for any reason
Additional study locations may be listed as they open in the future. We encourage you to share this information via the links at the top of the page.