RANDOMIZED DOUBLE-BLIND, MULTIPLE DOSE, PLACEBO-CONTROLLED STUDY TO DETERMINE THE INSULIN SENSITIZING EFFECT OF BGP-15 IN PATIENTS WITH INSULIN RESISTANCE - THE INSULIN SENSITIZING EFFECT OF BGP-15

Active, not recruiting

Conditions: The metabolic syndrome is characterized by central obesity, atherogenic dyslipidemia, insulin resistance or glucose intolerance
prothrombotic state
raised blood pressure, proinflammatory state

Registration Number: EUCTR2005-000872-41-HU

Lead Sponsor: -Gene Research & Development Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the putative insulin sensitizing effect of BGP-15 in patients with insulin resistance assessed by <br>a) the hyperinsulinemic euglycemic clamp technique and<br>b) the homeostasis model assessment method (HOMA-IR) with 2 different doses (200 mg or 400 mg) of BGP -15.<br>;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.

Secondary Outcome Measures