EUCTR2016-004124-26-GB
Active, not recruiting
Phase 1
A randomized, subject- and investigator-blinded, placebo-controlled study to assess the safety, pharmacokinetics and efficacy of intravenous bimagrumab in overweight and obese patients with type 2 diabetes
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- ovartis Pharma AG
- Enrollment
- 78
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Type 2 diabetes with HbA1c between 7% and 10% at screening with stable treatment for 3 months prior to randomization
- •\- Body Mass Index of 28 to 40 kg/m2 at screening
- •\- Body weight between 65 and 140 kg at screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 45
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 15
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 ofr 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)
- •\- uncontrolled thyroid disease. Stable euthyroid patients on stable thyroid replacement therapy for at least 3 months of
- •screening are allowed
Outcomes
Primary Outcomes
Not specified
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