Status:
COMPLETED
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Saniona
Collaborating Sponsors:
Profil Institut für Stoffwechselforschung GmbH
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
Detailed Description
This is a double-blind, randomized, placebo-controlled, multiple-dose, two-center, safety and efficacy study of co-administration of tesofensine/metoprolol treatment in subjects with T2DM. Study medic...
Eligibility Criteria
Inclusion
- Males and females
- Confirmed diagnosis of T2DM
- 18-70 years of age
- HbA1c ≥7.0%
Exclusion
- Hypersensitivity to tesofensine/metoprolol
- Heart failure class II or greater according to the New York Heart Association (NYHA) or decompensated heart failure
- History of myocardial infarction or stroke within 12 months prior to enrolment
- History of coronary revascularisation or angioplasty in the last 12 months prior to enrolment
- Patients reporting angina in the last 6 months prior to enrolment
- Treatment with insulin and/or other injectable anti-diabetic medications, or TZDs
- Any clinically significant cardiac arrhythmia
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02737891
Start Date
April 1 2016
End Date
March 1 2017
Last Update
May 14 2020
Active Locations (1)
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1
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, D-41460