Efficacy, Safety and Satisfaction of the New Pen Needle 33 Gauge x 4 mm. (AGO01)
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| ClinicalTrials.gov Identifier: NCT01745549 |
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Recruitment Status :
Completed
First Posted : December 10, 2012
Last Update Posted : March 18, 2014
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Sponsor:
Consorzio Mario Negri Sud
Collaborator:
Artsana SpA
Information provided by (Responsible Party):
Antonio Nicolucci, Consorzio Mario Negri Sud
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 87 participants |
| 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 |
| Study Start Date : | December 2012 |
| Actual Primary Completion Date : | September 2013 |
| Actual Study Completion Date : | November 2013 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: needle 4 mm gauge 33
Needle for insulin pen, 4 mm long and with a diameter of 33 gauge (the smaller needle)
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Device: Needle for insulin pen, 4 mm long and with a diameter of 33 gauge |
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Active Comparator: needle 4 mm gauge 32
Needle for insulin pen, 4 mm long and with a diameter of 32 gauge
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Device: Needle for insulin pen, 4 mm long and with a diameter of 32 gauge |
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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
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 |
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 Posted: | December 10, 2012 Key Record Dates |
| Last Update Posted: | March 18, 2014 |
| Last Verified: | March 2014 |
Keywords provided by Antonio Nicolucci, Consorzio Mario Negri Sud:
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diabetes insulin therapy needle |
Additional relevant MeSH terms:
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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 |