Primary outcomeMean· Baseline to Day 90
Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate
| Group | Value (beats per minutes (BPM)) | Spread |
|---|---|---|
| Tesofensine/Metoprolol | 67 | 7 |
| Placebo | 70 | 9 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataSafety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
NCTNCT02737891 (opens ClinicalTrials.gov in a new tab)Other idTM001
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 60 participants (actual)
- Sponsor
- Saniona · Industry
- Design
- Randomized · Double masking
- Countries
1 country
Germany
- Start
- Apr 2016
- Primary completion
- Jan 2017
- Completion
- Mar 2017
- First posted
- 14 Apr 2016 (estimated)
- Last update posted
- 14 May 2020
- Conditions
- Type 2 Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201620172018
- Ph 2
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
NCT02737891Apr 2016 to Mar 2017
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
Interventions
- Tesofensine/MetoprololDrug
- PlaceboDrug
Arms2
Experimental
Tesofensine/Metoprolol
Oral tablets Tesofensine/Metoprolol
Placebo comparator
Placebo
Placebo tablets matching oral Tesofensine/Metoprolol
Primary outcomes1
Outcomes the sponsor listed as primary.
Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate
Time frame · Baseline to Day 90
Registry description
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(2)
Change From Baseline to End of Treatment in HbA1c
Time frame · Baseline to Day 90
Registry description
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).
Change From Baseline to End of Treatment in Body Weight
Time frame · Baseline to Day 90
Registry description
Change in kg body weight measured from baseline to day 90
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeMean· Baseline to Day 90
Change From Baseline to End of Treatment in HbA1c
| Group | Value (percentage of HbA1c) | Spread |
|---|---|---|
| Tesofensine/Metoprolol | 7.3 | 0.6 |
| Placebo | 7.4 | 0.7 |
Secondary outcomeMean· Baseline to Day 90
Change From Baseline to End of Treatment in Body Weight
| Group | Value (kg) | Spread |
|---|---|---|
| Tesofensine/Metoprolol | -3.5 | 19.9 |
| Placebo | -0.3 | 12.9 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Tesofensine/MetoprololOral tablets Tesofensine/Metoprolol Tesofensine/Metoprolol: Tesofensine 0.5 mg + Metoprolol 100 mg | 0 / 30 | 0 / 30 | 20 / 30 |
| PlaceboPlacebo tablets matching oral Tesofensine/Metoprolol Placebo | 0 / 30 | 1 / 30 | 12 / 30 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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