Title
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
A Double-blind, Randomized, Placebo-controlled, Multiple-dose, Two-center, Safety and Efficacy Study of Co-administration of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus (T2DM)
Phase
Phase 2Lead Sponsor
SanionaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Type 2 Diabetes MellitusIntervention/Treatment
tesofensine metoprolol ...Study Participants
60Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
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 medication will be administered for ninety (90) days (+2 days after the final assessments with half-dose of metoprolol). Following all baseline assessments, eligible subjects will be randomly assigned to one of the two arms (1:1).
Tesofensine 0.5 mg + Metoprolol 100 mg
Inclusion Criteria: Males and females Confirmed diagnosis of T2DM 18-70 years of age HbA1c ≥7.0% Exclusion Criteria: 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
| Event Type | Organ System | Event Term | Tesofensine/Metoprolol | Placebo |
|---|
24-hour heart rate monitoring was based on telemetry measurements at baseline (Day -1 to 1, V2) and at the end of treatment (Day 90 to 91, V10). The heart rate was measured every minute and the mean was recorded for every hour.
HbA1c was measured from blood samples collected at baseline (Day 1, V2) and at the end of treatment (Day 90, V10). Additional HbA1c measurements were done during various visits (V6, V8 and V12).
Change in kg body weight measured from baseline to day 90
