A STUDY OF CO-ADMINISTRATION OF TESOFENSINE/ METOPROLOL TREATMENT IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS

Phase 1

• Conditions: Diabetes mellitus type 2; MedDRA version: 18.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-005522-19-DE
• Lead Sponsor: Saniona, A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-23
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Males and females
2.Confirmed diagnosis of T2DM (either by being on anti-diabetic medication or by confirmed or repeated laboratory findings)
3.18-70 years of age
4.Normal BP or well managed hypertension (only if dose of BP medication(s) has been stable for at least two months)
5.Normal lipid profile or well managed dyslipidemia (only if dose of lipid-lowering medication(s) has been stable for at least 2 months)
6. No history of CV disease (as specified in exclusion criteria 7-10) or any other clinically relevant major disease
7.On any dose of metformin stable for at least two months, or
8.On any dose of metformin plus one other oral antidiabetic agent (except TZDs); the other oral agent will be washed out prior to randomization
9.HbA1c =7.0%

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1.BP > 140/90
2.HbA1c > 8.5%
3. Fasting Plasma glucose > 200 mg/dL at screening
4.HR = 90, <50 bpm
5.BMI < 27 kg/m2
6.Hypersensitivity to tesofensine/metoprolol
7.Heart failure class II or greater according to the New York Heart Association (NYHA) or decompensated heart failure
8.History of myocardial infarction or stroke within 12 months prior to enrolment
9.History of coronary revascularization or angioplasty in the last 12 months prior to enrolment
10.Patients reporting angina in the last 6 months prior to enrolment
11.Treatment with insulin and/or other injectable anti-diabetic medications, or TZDs
12.Any clinically significant cardiac arrhythmia
13.Treatment with calcium channel blockers or beta blockers or their combination
14.Current treatment with medications which should not be co-administered according to the excluded medications list (Appendix I)
15.Concomitant use of monoaminooxidase inhibitors
16.Bulimia or anorexia nervosa
17.Any agent used for weight loss within the last 3 months
18.Patients with history of major depressive disorder or any history of suicide attempt/ideation
19.Patients with family history of severe psychiatric diseases
20.Patients using selective serotonin reuptake inhibitors (SSRIs), antidepressants or anxiolytics.
21.PHQ-9 (Patient Health Questionannire) score = 10 or any score > 0 on question 9
22.Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods or postmenopausal women being amenorrheic for less than 1 year and not using highly effective contraceptive methods

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified