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

Type 2 Diabetes Mellitus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737891
• Other study ID #: TM001
• Status: Completed
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: March 2017

Study information

• Verified date: May 2020
• Source: Saniona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Tesofensine/Metoprolol
Tesofensine 0.5 mg + Metoprolol 100 mg
• Placebo

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (2)

Lead Sponsor	Collaborator
Saniona	Profil Institut für Stoffwechselforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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