| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | | dose escalating, multiple dose study with two groups of 30 volunteers with type II diabetes | |
| 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 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 | |
| E.2.2 | Secondary objectives of the trial | |
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. | |
| E.4 | Principal 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
| |
| E.5 End points |
| E.5.1 | 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 variablesto be studied are:
Safety (adverse events, ECG, vital signs) and clinical laboratory variables, pharmacokinetics
| |
| 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 | Yes |
| E.6.7 | Pharmacodynamic | Yes |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| 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 | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| 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 | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| 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 | Yes |
| 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 | | The end of the study is defined as the last contact with the last subject undergoing the study. | |
| 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 | 3 |
| E.8.9.1 | In the Member State concerned days | |
