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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:
Consorzio Mario Negri Sud
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: March 17, 2014
Last verified: March 2014
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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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01745549
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | December 5, 2012 |
| Last Updated: | March 17, 2014 |
Keywords provided by Antonio Nicolucci, Consorzio Mario Negri Sud:
|
diabetes insulin therapy needle |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 21, 2017