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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-03-31

Brief Summary

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

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Detailed Description

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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).

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tesofensine/Metoprolol

Oral tablets Tesofensine/Metoprolol

Group Type EXPERIMENTAL

Tesofensine/Metoprolol

Intervention Type DRUG

Tesofensine 0.5 mg + Metoprolol 100 mg

Placebo

Placebo tablets matching oral Tesofensine/Metoprolol

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Tesofensine/Metoprolol

Tesofensine 0.5 mg + Metoprolol 100 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Tesofensine Metoprolol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No