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

What Was Tested

This registered phase 2 trial tested Tesofensine (non-peptide).

It had two arms (groups): Tesofensine/Metoprolol (experimental) and Placebo (placebo comparator).

Oral tablets Tesofensine/Metoprolol.

Placebo tablets matching oral Tesofensine/Metoprolol.

The registry classes the interventions as drug.

More on the Plan

Following all baseline assessments, eligible subjects will be randomly assigned to one of the two arms (1:1).

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males and females. Confirmed diagnosis of T2DM. 18-70 years of age.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Tesofensine (non-peptide) and who got the comparison, which limits bias.

The Tesofensine (non-peptide) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Tesofensine (non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2016-04 with completion listed for 2017-01.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate (time frame: Baseline to Day 90).

It also tracked 2 secondary outcomes, for example Change From Baseline to End of Treatment in HbA1c and Change From Baseline to End of Treatment in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tesofensine (non-peptide) in 60 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Tesofensine (non-peptide) compound page, all human trials.