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

Study Overview
=================
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 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).

Official Title
-----------------
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)

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Tesofensine/Metoprolol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tesofensine/Metoprolol<br>Oral tablets Tesofensine/Metoprolol | Drug: Tesofensine/Metoprolol<br>* Tesofensine 0.5 mg + Metoprolol 100 mg<br>* Other names: Metoprolol;|
| Placebo Comparator: Placebo<br>Placebo tablets matching oral Tesofensine/Metoprolol | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | Baseline to Day 90 |