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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01745549
First Posted: December 10, 2012
Last Update Posted: March 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Artsana SpA
Information provided by (Responsible Party):
Antonio Nicolucci, Consorzio Mario Negri Sud
  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
Intervention Model: Crossover Assignment
Masking: None (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:


Further study details as provided by Antonio Nicolucci, Consorzio Mario Negri Sud:

Primary Outcome Measures:
  • hematic fructosamine levels [ Time Frame: Change from baseline in fructosamine levels after 3 weeks of treatment ]

Secondary Outcome Measures:
  • mean amplitude of glucose excursions (MAGE) [ Time Frame: Change from baseline in MAGE after 3 weeks of treatment ]
  • pain [ Time Frame: questionnaire at the end of the treatments (at 6 weeks) ]
    visual analogic scale (VAS) 1-10

  • leakage at the site injection [ Time Frame: number of episodes of leakage during the treatment (3 weeks) ]
    visual scale

  • hypoglycemia [ Time Frame: number of episodes of hypoglycemia during the treatment (3 weeks) ]
  • insulin dosage [ Time Frame: Change from baseline in insulin dosage after 3 weeks of treatment ]
  • patient's weight [ Time Frame: Change from baseline in weight after 3 weeks of treatment ]
  • patient's satisfaction [ Time Frame: questionnaire at the end of the treatments (at 6 weeks) ]
    VAS scale


Enrollment: 87
Study Start Date: December 2012
Study Completion Date: November 2013
Primary Completion Date: September 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745549


Locations
Italy
UO Malattie Metaboliche e Diabetologia - Ospedale di Treviglio-Caravaggio
Treviglio, BG, Italy, 24047
UO Diabetologia per Trattamento e Educazione dei Diabetici - Spedali Civili di Brescia
Brescia, BS, Italy, 25123
U.O.S. Diabetologia e Malattie Metaboliche - PO Cantù - Mariano Comense
Mariano Comense, CO, Italy, 22066
Struttura Complessa Dietologia-Diabetologia Malattie Metaboliche - Ospedale Pertini
Roma, RM, Italy, 00157
Sponsors and Collaborators
Consorzio Mario Negri Sud
Artsana SpA
Investigators
Study Chair: Antonio Nicolucci, MD Consorzio Mario Negri Sud
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Antonio Nicolucci, Dr Antonio Nicolucci, MD, Consorzio Mario Negri Sud
ClinicalTrials.gov Identifier: NCT01745549     History of Changes
Other Study ID Numbers: AGO01
First Submitted: December 5, 2012
First Posted: December 10, 2012
Last Update Posted: March 18, 2014
Last Verified: March 2014

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

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