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Efficacy, Safety and Satisfaction of the New Pen Needle 33 Gauge x 4 mm. (AGO01)

This study is currently recruiting participants.
Verified December 2012 by Consorzio Mario Negri Sud
Sponsor:
Collaborator:
Artsana SpA
Information provided by (Responsible Party):
Antonio Nicolucci, Consorzio Mario Negri Sud
ClinicalTrials.gov Identifier:
NCT01745549
First received: December 5, 2012
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

During the last years, even more little needles are used for the injection of sub cutaneous insulin, for the diabetes therapy.

The aim of this study is to evaluate the non inferiority of a new needle, smaller than another needle, in terms of hematic levels od fructosamine, an indicator of glycemic control.


Condition Intervention
Type 1 Diabetes
Type 2 Diabetes
 Device: Needle for insulin pen, 4 mm long and with a diameter of 33 gauge
Device: Needle for insulin pen, 4 mm long and with a diameter of 32 gauge

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Satisfaction of the New Pen Needle 33G x 4 mm 33G x 4 mm: Cross-over Randomized Controlled Clinical Trial. Studio AGO 01

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Consorzio Mario Negri Sud:

Primary Outcome Measures:
  • hematic fructosamine levels [ Time Frame: Change from baseline in fructosamine levels after 3 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean amplitude of glucose excursions (MAGE) [ Time Frame: Change from baseline in MAGE after 3 weeks of treatment ] [ Designated as safety issue: No ]
  • pain [ Time Frame: questionnaire at the end of the treatments (at 6 weeks) ] [ Designated as safety issue: No ]
    visual analogic scale (VAS) 1-10

  • leakage at the site injection [ Time Frame: number of episodes of leakage during the treatment (3 weeks) ] [ Designated as safety issue: No ]
    visual scale

  • hypoglycemia [ Time Frame: number of episodes of hypoglycemia during the treatment (3 weeks) ] [ Designated as safety issue: Yes ]
  • insulin dosage [ Time Frame: Change from baseline in insulin dosage after 3 weeks of treatment ] [ Designated as safety issue: No ]
  • patient's weight [ Time Frame: Change from baseline in weight after 3 weeks of treatment ] [ Designated as safety issue: No ]
  • patient's satisfaction [ Time Frame: questionnaire at the end of the treatments (at 6 weeks) ] [ Designated as safety issue: No ]
    VAS scale


Estimated Enrollment: 80
Study Start Date: December 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: needle 4 mm gauge 33
Needle for insulin pen, 4 mm long and with a diameter of 33 gauge (the smaller needle)
 Device: Needle for insulin pen, 4 mm long and with a diameter of 33 gauge
Active Comparator: needle 4 mm gauge 32
Needle for insulin pen, 4 mm long and with a diameter of 32 gauge
 Device: Needle for insulin pen, 4 mm long and with a diameter of 32 gauge

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with type 1 or type 2 diabetes
  • both males and females
  • age >=18 anni
  • insulin treatment from at least 6 months
  • signed informed consent

Exclusion Criteria:

  • pregnancy
  • incapacity for filling in the questionnaires
  • every illness or condition that, according to the investigator, could interfere with the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745549

Contacts
Contact: Miriam Valentini, MD +39 0872 570311 valentini@negrisud.it
Contact: Antonio Nicolucci, MD +39 0872 570260 nicolucci@negrisud.it

Locations
Italy
UO Malattie Metaboliche e Diabetologia - Ospedale di Treviglio-Caravaggio Not yet recruiting
Treviglio, BG, Italy, 24047
Contact: Antonio Bossi, MD     +39 0363 424385     antonio_bossi@ospedale.treviglio.bg.it    
Principal Investigator: Antonio Bossi, MD            
UO Diabetologia per Trattamento e Educazione dei Diabetici - Spedali Civili di Brescia Recruiting
Brescia, BS, Italy, 25123
Contact: Liliana Rocca, MD     +39 030 3995514     susi.rocca@gmail.com    
Principal Investigator: Angela Girelli, MD            
Sub-Investigator: Liliana Rocca, MD            
U.O.S. Diabetologia e Malattie Metaboliche - PO Cantù - Mariano Comense Not yet recruiting
Mariano Comense, CO, Italy, 22066
Contact: Luigi Sciangula, MD     +39 031 755355     luigi.sciangula@hsacomo.org    
Principal Investigator: Luigi Sciangula, MD            
Struttura Complessa Dietologia-Diabetologia Malattie Metaboliche - Ospedale Pertini Recruiting
Roma, RM, Italy, 00157
Contact: Antonietta Colatrella, MD     +39 06 41433402     colanto@inwind.it    
Contact: Lucia Fontana, MD     +39 06 41433402     fontanalucia@gmail.com    
Principal Investigator: Sergio Leotta, MD            
Sponsors and Collaborators
Consorzio Mario Negri Sud
Artsana SpA
Investigators
Study Chair: Antonio Nicolucci, MD Consorzio Mario Negri Sud
  More Information

No publications provided

Responsible Party: Antonio Nicolucci, Dr Antonio Nicolucci, MD, Consorzio Mario Negri Sud
ClinicalTrials.gov Identifier: NCT01745549     History of Changes
Other Study ID Numbers: AGO01
Study First Received: December 5, 2012
Last Updated: December 6, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Consorzio Mario Negri Sud:
diabetes
insulin therapy
needle

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013