dose escalating, multiple dose study with two groups of 30 volunteers with type II diabetes
Conditions
Interventions
Product Code: 50 mg BLX-1002
Pharmaceutical Form: Capsule, hard
Current Sponsor code: BLX-1002
Other descriptive name: (S)-2-Amino-3-{4[4-(2,4-dioxothiazolidin-5-ylmethyl)-phenoxy]-phenyl}-propionic a
Sponsors
Bexel Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female subjects with type II diabetes and increased triglyceride level of any ethic origin who are non- or light smokers (= 10 cig./day), 30 through 75 years of age, will be recruited from the local population and 60 eligible subjects will be included in the study after having given voluntary written informed consent before first invasive screening examination procedure. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ·Type I diabetes ·Treatment with insulin ·History of ketoacidosis or unstable diabetes with severe hypoglycemic episodes ·History of cardiac problems: - decompensated heart failure (NYHA III to IV). - diagnosis of angina pectoris. - previous myocardial infarction - ischemic heart disease, confirmed by ECG ·History of cancer or presence of cancer, or any clinically significant respiratory, renal, hepatic, gastrointestinal, venereal, hematological, or psychiatric diseases or disorder. ·Severe diabetic peripheral neuropathy, severe diabetic retinopathy or symptomatic diabetic nephropathy requiring tight glycaemic control. ·Major surgery within the last year, major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to the first medication. ·Severe digestive disorder or surgery of the digestive tract (except for appendectomy) ·Participation in a clinical trial with an investigational drug within 30 days prior to first study drug administration. ·History of alcohol and/or other substance abuse or addiction within the last year. ·Positive screening for drugs of abuse at screening and at Day -1. ·Donation of >500 mL of blood within the 2 months preceding first study drug administration. ·Positive virology screen for HIV or Hepatitis B or C. ·History of significant drug allergy or drug hypersensitivity ·Subject not willing to comply to a diabetic diet Present Condition: ·Clinically relevant deviations of any finding during the pre-study examination - vital signs - physical examination - ECG - laboratory tests ·Severe, controlled/uncontrolled hypertension (SBP >170 mmHg and/or DBP > 100 mmHg) in the supine position ·Treated hypertensive patients who are not on a stable antihypertensive medication for at least 4 weeks. ·Impaired renal function: creatinine =150 µM. ·Impaired hepatic function (ALT, AST or alkaline phosphatase =3 times upper normal limit). ·Female subjects of child bearing potential (only female subjects who are postmenopausal [12 month of spontaneous amenorrhea at screening] or surgically sterile [bilateral oophorectomy with or without hysterectomy] or hysterectomy without oophorectomy may be enrolled) ·Refusal or inability to give written informed consent ·Inability to participate in the entire trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the pharmacodynamics with particular emphasis on blood glucose profile and triglycerides of BLX-1002. To assess the multiple dose pharmacokinetics at Day 1 and Day 28;Secondary Objective: ;Primary end point(s): Primary variables to be studied in detail are: Blood glucose profile (average plasma glucose level taken from seven values), blood glucose, insulin and c-peptide Secondary variables to be studied are: Maximum blood glucose level within 4 hours after breakfast (meal tolerance test), insulin, c-peptide, fasting blood glucose, triglycerides, blood pressure, cholesterol, LDL, HDL, VLDL, fructosamine Additional variables to be studied are: Safety (adverse events, ECG, vital signs) and clinical laboratory variables, pharmacokinetics | — |
Countries
Germany
Outcome results
None listed