Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
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)
1 other identifier
interventional
60
1 country
1
Brief Summary
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes-mellitus
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 5, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedResults Posted
Study results publicly available
May 14, 2020
CompletedMay 14, 2020
May 1, 2020
9 months
April 5, 2016
September 18, 2017
May 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change From Baseline to End of Treatment in HbA1c
Baseline to Day 90
Change From Baseline to End of Treatment in Body Weight
Baseline to Day 90
Study Arms (2)
Tesofensine/Metoprolol
EXPERIMENTALOral tablets Tesofensine/Metoprolol
Placebo
PLACEBO COMPARATORPlacebo tablets matching oral Tesofensine/Metoprolol
Interventions
Tesofensine 0.5 mg + Metoprolol 100 mg
Eligibility Criteria
You may qualify if:
- Males and females
- Confirmed diagnosis of T2DM
- years of age
- HbA1c ≥7.0%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanionalead
- Profil Institut für Stoffwechselforschung GmbHcollaborator
Study Sites (1)
Profil Institut für Stoffwechselforschung GmbH
Neuss, D-41460, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kim Krogsgaard
- Organization
- Saniona A/S
Study Officials
- STUDY DIRECTOR
Jørgen Drejer, PhD
Saniona
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2016
First Posted
April 14, 2016
Study Start
April 1, 2016
Primary Completion
January 1, 2017
Study Completion
March 1, 2017
Last Updated
May 14, 2020
Results First Posted
May 14, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share