Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2008-006763-36-DE
EUCTR2008-006763-36-DEActive, not recruitingNot Applicable

Randomized, double-blind study comparing the immunogenicity of two different brands of human insulin for the treatment of diabetes

Marvel Life Sciences Limited0 sites500 target enrollmentStarted: March 18, 2009Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
500
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

  • •[[1]male and female patients suffering from type 1 or type 2 diabetes mellitus for at least 6 months before randomization
  • •[2]negative screening assay for antibodies against insulin before the start of treatment
  • •[3]age 18-75 years
  • •[4]Body Mass Index (BMI) =35 kg/m2
  • •[5]informed consent given in a written form after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug
  • •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

  • •[1]known hypersensitivity against insulin or any of the inactive components of the formulations
  • •[2]known extreme resistance to insulin (daily dose of more than 200 IU)
  • •[3]severe renal failure (NKF stage 4-5) or patients on hemodialysis
  • •[4]severe cardiac failure (NYHA III-IV)
  • •[5]myocardial infarction within the last 6 months before randomization
  • •[6]unstable angina pectoris
  • •[7]stroke within the last 6 months before randomization
  • •[8]liver failure with ascites
  • •[9]severe peripheral vascular disease with ulceration or amputation
  • •[10]cancer
  • •[11]concomitant treatment with corticosteroids (except stable dose of inhaled corticosteroids)
  • •[12]concomitant treatment with immunosuppressive agents (e.g. cyclosporine A, methotrexate, etc.)
  • •[13]concomitant treatment with somatotropine
  • •[14]pregnancy or lactation period in female patients
  • •[15]severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol or the evaluation of efficacy or safety
  • •[16]anamnestic or current alcohol abuse i.e. consumption of more than 10 units of alcohol per week or a history of alcoholism or drug/chemical abuse (one unit of alcohol equals 250 ml of beer, 125 ml wine or 25 ml of spirits)
  • •[17]participation in another clinical trial within the last 12 weeks
  • •[18]legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
  • •[19]unreliability or lack of cooperation
  • •[20]lack of a possibility to attend the visits required by protocol.

Investigators

Sponsor
Marvel Life Sciences Limited

Similar Trials

Completed
Phase 3
A clinical trial Comparing the immunogenicity of two different brands of human Insulin for the treatment of diabetes.
CTRI/2009/091/000862Spectrum Clinical Research Pvt Ltd500
Active, not recruiting
Not Applicable
Randomized, double-blind study comparing the immunogenicity of two different brands of human insulin for the treatment of diabetes
EUCTR2008-006763-36-BGMarvel Life Sciences Limited500
Active, not recruiting
Not Applicable
Randomized, double-blind, study to compare the incidence and intensity lf neurologic and pschiatic adverse events of efavirenz when given as a stepped dosage (200 mg qd for 6 days, 400 mg qd for 7 days and 600 mg qd from the day 14 farward) with the usual dosage (600 mg qd from first day)Pacientes infectados por el VIH a los que su medico responsable les haya prescrito efavirez como parte de su tratamiento antiretroviralMedDRA version: 6.0Classification code 10008919
EUCTR2005-003243-31-ESuis Fernando López Cortés100
Active, not recruiting
Not Applicable
A randomized, double-blind study comparing the efficacy and safety of a fixed combination of fenofibrate and metformin vs metformin alone in patients with type 2 diabetes mellitus and dyslipidemia not appropriately controlled with a statin - fenofibrate and metformin fixed combination vs metformiPatients with type 2 diabetes mellitus and dyslipidemia not appropriately controlled with a statin
EUCTR2006-000924-15-HUFOURNIER Laboratories Ireland Ltd480
Active, not recruiting
Phase 1
Efficacy and safety of trazodone OAD and venlafaxine XR in the treatment of Major Depressive Disorder.Major depressive disorderMedDRA version: 19.0Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 19.0Level: HLGTClassification code 10012375Term: Depressed mood disorders and disturbancesSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 19.0Level: HLTClassification code 10012401Term: Depressive disordersSystem Organ Class: 10037175 - Psychiatric disorders
EUCTR2011-005878-37-ESAziende Chimiche Riunite Angelini Francesco - ACRAF S.p.A.360