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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737891
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : May 14, 2020
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
Profil Institut für Stoffwechselforschung GmbH
Information provided by (Responsible Party):
Saniona

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Tesofensine/Metoprolol Drug: Placebo Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737891


Locations
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Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, D-41460
Sponsors and Collaborators
Saniona
Profil Institut für Stoffwechselforschung GmbH
Investigators
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Study Director: Jørgen Drejer, PhD Saniona
  Study Documents (Full-Text)

Documents provided by Saniona:
Study Protocol  [PDF] March 9, 2016
Statistical Analysis Plan  [PDF] November 30, 2016

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Responsible Party: Saniona
ClinicalTrials.gov Identifier: NCT02737891    
Other Study ID Numbers: TM001
First Posted: April 14, 2016    Key Record Dates
Results First Posted: May 14, 2020
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metoprolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action