| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | | The metabolic syndrome is characterized by central obesity, atherogenic dyslipidemia, insulin resistance or glucose intolerance; prothrombotic state; raised blood pressure, proinflammatory state | |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial | 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.
| |
| E.2.2 | Secondary objectives of the trial | |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal 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 <11.1 mmol/ AND
Insulin resistance should be confirmed with the HOMA–IR test (higher than 2.5)
Abdominal obesity: waist-to-hip ratio >0.90 in men or >0.85 in women, or BMI >27
Written informed consent
| |
| E.4 | Principal 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
| |
| E.5 End points |
| E.5.1 | 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. | |
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Information not present in EudraCT |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Information not present in EudraCT |
| E.8.1.3 | Single blind | Information not present in EudraCT |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Information not present in EudraCT |
| E.8.1.6 | Cross over | Information not present in EudraCT |
| E.8.1.7 | Other | Information not present in EudraCT |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | Information not present in EudraCT |
| E.8.3 | The trial involves single site in the Member State concerned | Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
| E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
