Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saniona
• Collaborator: Profil Institut für Stoffwechselforschung GmbH
• Treatments: Metoprolol

Criteria

Inclusion Criteria:

1. Males and females

2. Confirmed diagnosis of T2DM

3. 18-70 years of age

4. HbA1c ≥7.0%

Exclusion Criteria:

1. Hypersensitivity to tesofensine/metoprolol

2. Heart failure class II or greater according to the New York Heart Association (NYHA) or decompensated heart failure

3. History of myocardial infarction or stroke within 12 months prior to enrolment

4. History of coronary revascularisation or angioplasty in the last 12 months prior to enrolment

5. Patients reporting angina in the last 6 months prior to enrolment

6. Treatment with insulin and/or other injectable anti-diabetic medications, or TZDs

7. Any clinically significant cardiac arrhythmia