Type 2 diabetes mellitus MedDRA version: 16.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: Yohimbine
Pharmaceutical Form: Capsule
INN or Proposed INN: Yohimbine
CAS Number: 66-19-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceu
Sponsors
Lund University
Region Skåne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent Males between 18 and 70 years; postmenopausal women below 70 years C-peptide 0.35-1.8 nmol/L HbA1c = 80 mmol/mol according to IFCC 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 280 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 280
Exclusion criteria
Exclusion criteria: Ongoing treatment with insulin, other injected antidiabetic treatment, or oral antidiabetic treatment except metformin GAD antibodies Dysregulated hypertension Glaucoma Known coronary artery disease or arrythmia Known current or previous ventricular or duodenal ulcer Known anxiety syndrome Ongoing treatment with alpha- or beta-adrenergic blockers Creatinine > 130 micromol/L Liver failure Mental disability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to investigate whether yohimbine improves insulin secretion during an oral glucose tolerance test in patients with type 2 diabetes carrying the genetic risk variant for ADRA2A rs553668.;Secondary Objective: Secondary objectives are to determine the optimal yohimbine dose regarding effect vs. adverse effects, to examine whether daily yohimbine administration affects the treatment response compared with acute doses, to study whether yohimbine is more effective in risk allele carriers for rs553668 compared with non-risk allele carriers, and to study whether yohimbine in addition to insulin could also affect other metabolic parameters.;Primary end point(s): Improved insulin secretion by 11% in risk allele carriers for ADRA2A rs553668 measured by the insulin levels at 30 minutes during an oral glucose tolerance test.;Timepoint(s) of evaluation of this end point: During dose escalation phase, i.e. within 6 weeks from start of study for each patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Improved plasma insulin at 0 and 120 minutes during an oral glucose tolerance test. ;Timepoint(s) of evaluation of this end point: During dose escalation phase, i.e. within 6 weeks from start of study for each patient. | — |
Countries
Sweden
Contacts
Public ContactAnders Rosengren
Lund University
Outcome results
None listed