Diabetes mellitus type 2 MedDRA version: 18.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: Tesofensine
Pharmaceutical Form: Tablet
INN or Proposed INN: Tesofensine
Other descriptive name: TESOFENSINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
Saniona, A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1.BP > 140/90 2.HbA1c > 8.5% 3. Fasting Plasma glucose > 200 mg/dL at screening 4.HR = 90, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To compare the effects of co-administration of tesofensine/ metoprolol treatment vs. placebo on systolic and diastolic blood pressure • To demonstrate a positive effect of co-administration of tesofensine/ metoprolol treatment on: o body weight o glycaemic endpoints o body composition (liver fat) • To evaluate overall safety and tolerability of co-administration of tesofensine/metoprolol treatment ;Main Objective: To compare the effects of co-administration of tesofensine/ metoprolol treatment vs. placebo on 24-hour mean heart rate;Primary end point(s): Change from baseline to end of treatment in mean 24 hour HR ;Timepoint(s) of evaluation of this end point: 0-24 h (Baseline on Day -1/1; End of treatment on Day 90/91) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline to end of treatment in mean SBP • Change from baseline to end of treatment in mean DBP • Change from baseline to end of treatment in body weight • Change from baseline to end of treatment in HbA1c • Change from baseline to end of treatment in FPG • Change from baseline to end of treatment in 9-point blood glucose Profile ;Timepoint(s) of evaluation of this end point: from baseline to end of treatment | — |
Countries
Germany
Contacts
Public ContactMikael S. Thomsen
Saniona, A/S
Outcome results
None listed