Trial · NCT02737891
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
NCT02737891, Phase 2, Completed, Saniona; results first posted 2020-05-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus. Trials, record NCT02737891. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02737891
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
- NCT number
- NCT02737891
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Saniona
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Tesofensine/Metoprolol, Placebo
- First posted
- 2016-04-14
- Last updated
- 2020-05-14
- Results first posted
- 2020-05-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate | 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 | Change From Baseline to End of Treatment in HbA1c | 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). |
| Secondary | Change From Baseline to End of Treatment in Body Weight | Baseline to Day 90 | Change in kg body weight measured from baseline to day 90 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate | Baseline to Day 90 | beats per minutes (BPM) | MEAN | |
| SECONDARY | Change From Baseline to End of Treatment in HbA1c | Baseline to Day 90 | percentage of HbA1c | MEAN | |
| SECONDARY | Change From Baseline to End of Treatment in Body Weight | Baseline to Day 90 | kg | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate | Tesofensine/Metoprolol | 67 | Standard Deviation 7 | beats per minutes (BPM) | |
| Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate | Placebo | 70 | Standard Deviation 9 | beats per minutes (BPM) | |
| Change From Baseline to End of Treatment in HbA1c | Tesofensine/Metoprolol | 7.3 | Standard Deviation 0.6 | percentage of HbA1c | |
| Change From Baseline to End of Treatment in HbA1c | Placebo | 7.4 | Standard Deviation 0.7 | percentage of HbA1c | |
| Change From Baseline to End of Treatment in Body Weight | Tesofensine/Metoprolol | -3.5 | Standard Deviation 19.9 | kg | |
| Change From Baseline to End of Treatment in Body Weight | Placebo | -0.3 | Standard Deviation 12.9 | kg |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tesofensine/Metoprolol | 30 | |
| Overall Study | STARTED | Placebo | 30 | |
| Overall Study | COMPLETED | Tesofensine/Metoprolol | 30 | |
| Overall Study | COMPLETED | Placebo | 28 | |
| Overall Study | NOT COMPLETED | Tesofensine/Metoprolol | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events102
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Tesofensine/Metoprolol | 1 | 30 | 1 |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 30 | 0 |
| other | Tachycardia | Cardiac disorders | Tesofensine/Metoprolol | 1 | 30 | 1 |
| other | Tachycardia | Cardiac disorders | Placebo | 0 | 30 | 0 |
| other | Visual impairment | Eye disorders | Tesofensine/Metoprolol | 1 | 30 | 1 |
| other | Visual impairment | Eye disorders | Placebo | 0 | 30 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Tesofensine/Metoprolol | 1 | 30 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 1 | 30 | 1 |
| other | Abnormal faeces | Gastrointestinal disorders | Tesofensine/Metoprolol | 1 | 30 | 1 |
| other | Abnormal faeces | Gastrointestinal disorders | Placebo | 0 | 30 | 0 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tesofensine/Metoprolol | 0 | 30 |
| Total, all-cause mortality | Placebo | 0 | 30 |
| Total, other adverse events | Tesofensine/Metoprolol | 20 | 30 |
| Total, other adverse events | Placebo | 12 | 30 |
| Total, serious adverse events | Tesofensine/Metoprolol | 0 | 30 |
| Total, serious adverse events | Placebo | 1 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tesofensine/Metoprolol vs Placebo: deaths from any cause | Trial comparisons |
| Tesofensine/Metoprolol vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02737891
GET https://conductscience.org/api/trials/v1/NCT02737891/events?page=2