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Completed

NCT Number: NCT02737891

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, D-41460, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females
  • Confirmed diagnosis of T2DM
  • 18-70 years of age
  • HbA1c ≥7.0%

Exclusion criteria

  • 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
  • History of coronary revascularisation or angioplasty in the last 12 months prior to enrolment
  • Patients reporting angina in the last 6 months prior to enrolment
  • Treatment with insulin and/or other injectable anti-diabetic medications, or TZDs
  • Any clinically significant cardiac arrhythmia

Treatment and study plan

Tesofensine/Metoprolol

Drug

Tesofensine 0.5 mg + Metoprolol 100 mg

Other names: Tesofensine, Metoprolol

Placebo

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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

Sponsors and collaborators

Lead sponsor

Saniona

Industry

Collaborators

  • Profil Institut für Stoffwechselforschung GmbH

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2016
Registry last updated
May 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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