NCT02737891

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Saniona · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Tesofensine/Metoprolol	Tesofensine 0.5 mg + Metoprolol 100 mg
DRUG	Placebo

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-01-01
• Completion: 2017-03-01
• First posted: 2016-04-14
• Last updated: 2020-05-14
• Results posted: 2020-05-14

Locations

1 site across 1 country: Germany