Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Tesofensine/Metoprolol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
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
Sites / Locations
- Profil Institut für Stoffwechselforschung GmbH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tesofensine/Metoprolol
Placebo
Arm Description
Oral tablets Tesofensine/Metoprolol
Placebo tablets matching oral Tesofensine/Metoprolol
Outcomes
Primary Outcome Measures
Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate
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 Outcome Measures
Change From Baseline to End of Treatment in HbA1c
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
Change in kg body weight measured from baseline to day 90
Full Information
NCT ID
NCT02737891
First Posted
April 5, 2016
Last Updated
May 4, 2020
Sponsor
Saniona
Collaborators
Profil Institut für Stoffwechselforschung GmbH
1. Study Identification
Unique Protocol Identification Number
NCT02737891
Brief Title
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
Official Title
A Double-blind, Randomized, Placebo-controlled, Multiple-dose, Two-center, Safety and Efficacy Study of Co-administration of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus (T2DM)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saniona
Collaborators
Profil Institut für Stoffwechselforschung GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tesofensine/Metoprolol
Arm Type
Experimental
Arm Description
Oral tablets Tesofensine/Metoprolol
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets matching oral Tesofensine/Metoprolol
Intervention Type
Drug
Intervention Name(s)
Tesofensine/Metoprolol
Other Intervention Name(s)
Tesofensine, Metoprolol
Intervention Description
Tesofensine 0.5 mg + Metoprolol 100 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate
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.
Time Frame
Baseline to Day 90
Secondary Outcome Measure Information:
Title
Change From Baseline to End of Treatment in HbA1c
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).
Time Frame
Baseline to Day 90
Title
Change From Baseline to End of Treatment in Body Weight
Description
Change in kg body weight measured from baseline to day 90
Time Frame
Baseline to Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jørgen Drejer, PhD
Organizational Affiliation
Saniona
Official's Role
Study Director
Facility Information:
Facility Name
Profil Institut für Stoffwechselforschung GmbH
City
Neuss
ZIP/Postal Code
D-41460
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
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