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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Tesofensine/Metoprolol; Drug: Placebo

• Registration Number: NCT02737891
• Lead Sponsor: Saniona

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).

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-14
• Primary Completion: 2017-01
• Study Completion: 2017-03
• Results First Submitted: 2017-09-18
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-04
• Last Update Submitted: 2020-05-04
• Results First Posted: 2020-05-14
• Last Update Posted: 2020-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tesofensine/Metoprolol	Tesofensine/Metoprolol	Oral tablets Tesofensine/Metoprolol
Placebo	Placebo	Placebo tablets matching oral Tesofensine/Metoprolol

Primary Outcome Measures

Name	Time	Method
Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate	Baseline to Day 90	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to End of Treatment in HbA1c	Baseline to Day 90	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 From Baseline to End of Treatment in Body Weight	Baseline to Day 90	Change in kg body weight measured from baseline to day 90

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany