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Clinical Trials/EUCTR2006-002852-13-DE
EUCTR2006-002852-13-DEActive, not recruitingNot Applicable

Double blind, placebo-controlled dose escalating, multiple dose study with two groups of 30 volunteers with type II diabetes to assess efficacy on glucose-profile, triglycerides and blood pressure and pharmacokinetics of two different doses of BLX-1002

Bexel Pharmaceuticals Inc.0 sites60 target enrollmentStarted: June 21, 2006Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
60
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

  • •·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
  • •- 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

Investigators

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