The metabolic syndrome is characterized by central obesity, atherogenic dyslipidemia, insulin resistance or glucose intolerance
Conditions
Interventions
Product Name: BGP-15 capsules
Product Code: BGP-15
Pharmaceutical Form: Capsule, soft
CAS Number: 66611-37-8
Current Sponsor code: BGP-15
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
N-Gene Research & Development Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients, 25-60 years (females only if being /hysterectomised/ surgically sterilized) Altered glucose metabolism with insulin resistance IFG patients: Fasting blood sugar >6.1 mmol/l and less than 7.0 mmol/l, OR IGT patients: Fasting blood sugar =7.0 and 2 hour blood sugar during OGTT is 0.90 in men or >0.85 in women, or BMI >27 Written informed consent 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 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Type-I diabetes mellitus Drug-treated type II diabetes mellitus Uncontrolled hypertension (systolic BP >160 mmHg; diastolic BP >95 mmHg). Patients with stable antihypertensive therapy (no change in drug dosage during 6 months before the study start ) can be enrolled. Ischaemic heart disease requiring nitrate therapy Heart failure (NYHA III or IV) or having being admitted for heart failure exacerbation in the last 3 months Malabsorption, gastro-intestinal bypass, acute or chronic pancreatitis ALT >2.5 times the upper limit of the normal Serum creatinine >135 µmol/l Clinically significant anemia (hematocrit <30%) Active inflammatory disease History of cancer in the last 5 years (except skin basal cell carcinoma) Lactation, pregnancy or birth control with hormones Alcohol or drug abuse (in the last 2 years) Other significant organ system illness or condition (including psychiatric, cardiac, endocrine) requiring drug treatment with medications with known metabolic effects. Gastroenterological, urogenital, respiratory, musculoskeletal and immunological disorders Hypersensitivity to nicotinic acid Participation in a clinical trial within 3 months before start of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the putative insulin sensitizing effect of BGP-15 in patients with insulin resistance assessed by a) the hyperinsulinemic euglycemic clamp technique and b) the homeostasis model assessment method (HOMA-IR) with 2 different doses (200 mg or 400 mg) of BGP -15. ;Secondary Objective: ;Primary end point(s): The primary efficacy parameter will be assessed by hyperinsulinemic euglycemic clamp tests after 28 day treatment by the IMP as compared to results of euglycemic clamp tests before taking IMP. | — |
Countries
Hungary
Outcome results
None listed