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

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ClinicalTrials.gov Identifier: NCT02737891
Recruitment Status : Unknown
Verified November 2016 by Saniona.
Recruitment status was:  Active, not recruiting
First Posted : April 14, 2016
Last Update Posted : December 1, 2016
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)
Study Start Date : April 2016
Estimated Primary 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

Placebo Comparator: Placebo
Placebo tablets matching oral Tesofensine/Metoprolol
Drug: Placebo



Primary Outcome Measures :
  1. Change from baseline to end of treatment in mean 24 hour HR [ Time Frame: Baseline to Day 90 ]

Secondary Outcome Measures :
  1. Change from baseline to end of treatment in HbA1c [ Time Frame: 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: Roman V. Dvorak, MD Saniona

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Responsible Party: Saniona
ClinicalTrials.gov Identifier: NCT02737891     History of Changes
Other Study ID Numbers: TM001
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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