Phase 2 Completed N=60 Randomized Double-blind Treatment

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

Source: ClinicalTrials.gov NCT02737891 ↗

Enrolled (actual)

Serious AEs

1.7%

Results posted

May 2020

Primary outcomePrimary: Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate — 67; 70 beats per minutes (BPM) — p=0.004

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate	67; 70	0.004 sig
SECONDARY Change From Baseline to End of Treatment in HbA1c	7.3; 7.4	0.724
SECONDARY Change From Baseline to End of Treatment in Body Weight	-3.5; -0.3	<0.0001 sig

Eligibility Criteria

Inclusion Criteria

Males and females
Confirmed diagnosis of T2DM
18-70 years of age
HbA1c ≥7.0%

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02737891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.