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

May 4, 2020 updated by: Saniona

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, D-41460
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tesofensine/Metoprolol
Oral tablets Tesofensine/Metoprolol
Drug: Tesofensine/Metoprolol
Tesofensine 0.5 mg + Metoprolol 100 mg
Other Names:
  • Tesofensine
  • Metoprolol
Placebo Comparator: Placebo
Placebo tablets matching oral Tesofensine/Metoprolol
Drug: Placebo

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
Time Frame: 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.
Baseline to Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to End of Treatment in HbA1c
Time Frame: 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).
Baseline to Day 90
Change From Baseline to End of Treatment in Body Weight
Time Frame: Baseline to Day 90
Change in kg body weight measured from baseline to day 90
Baseline to Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saniona

Collaborators

Profil Institut für Stoffwechselforschung GmbH

Investigators

  • Study Director: Jørgen Drejer, PhD, Saniona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

May 14, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TM001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe