Safety, Pharmacokinetics and Efficacy of Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Intervention: BYM338 10 mg/kg; Placebo
Intervention description: intravenous infusion every four weeks; intravenous infusion every four weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: type 2 diabetes; obesity; DXA; MRI

Summary:

      This study assessed the safety, pharmacokinetics and efficacy of bimagrumab when administered
      in overweight and obese patients with type 2 diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes with HbA1c between 6.5% and 10% at screening with stable treatment for
             3 months prior to randomization

          -  On one of the following anti-diabetes regimens with stable treatment for approximately
             3 months prior to randomization: 1) metformin monotherapy; 2) DPP4 inhibitor agent
             monotherapy; 3) combination therapy of metformin and DPP4 inhibitor agent; 4) no
             anti-diabetes therapy.

          -  Body Mass Index of 28 to 40 kg/m2 at screening

          -  Body weight between 65 and 140 kg at screening

        Exclusion Criteria:

          -  Women of child-bearing potential unless they are using highly effective methods of
             contraception

          -  Diabetes other than Type 2 such as Type 1 diabetes, surgically induced diabetes,
             "brittle" type 2 diabetes as per investigator judgement, history of severe
             hypoglycemic episodes in the year preceding screening or hypoglycemic unawareness

          -  History of clinically significant arrythmias, heart failure, unstable angina,
             myocardial infarction or stroke, coronary artery bypass graft surgery, or percutaneous
             coronary intervention, deep vein thrombosis/pulmonary embolism, valve disorders or
             defects, pulmonary hypertension within 6 months of screening or 1 year for
             drug-eluting stents

          -  Tachycardia

          -  Use of anti-obesity medications, nutritional supplements or over the counter products
             for weight loss within 3 months of screening

          -  Use of medications known to induce weight gain such as some anti-convulsant and
             psychotropic medications within 3 months of screening

          -  Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc) or has
             received anti-HCV treatments within the previous 6 months.

          -  Uncontrolled thyroid disease. Stable euthyroid patients on stable thyroid replacement
             therapy for at least 3 months of screening are allowed.

          -  Abnormal liver function tests such as SGOT, SGPT, alkaline phosphatase, or serum
             bilirubin, or abnormal lipase and/or amylase.

          -  Known history or presence of severe active acute or chronic liver disease (e.g.,
             cirrhosis).

          -  Uncontrolled depression

          -  Use of skeletal muscle anabolic agents in any form for 3 months prior to screening

          -  Chronic kidney disease [estimated glomerular filtration rate (GFR) < 30 mL/min];