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

Saniona60 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

Tesofensine/MetoprololDRUG

Tesofensine 0.5 mg + Metoprolol 100 mg

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Outcomes

Primary Outcomes

Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate

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.

Time frame: Baseline to Day 90

Secondary Outcomes

Change From Baseline to End of Treatment in HbA1c

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).

Time frame: Baseline to Day 90

Change From Baseline to End of Treatment in Body Weight

Change in kg body weight measured from baseline to day 90

Time frame: Baseline to Day 90

Data from ClinicalTrials.gov

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