Type 1 DiabetesAGO01NCT01745549
Efficacy, Safety and Satisfaction of the New Pen Needle 33 Gauge x 4 mm.
A study testing Needle for insulin pen, 4 mm long and with a diameter of 33 gauge and Needle for insulin pen, 4 mm long and with a diameter of 32 gauge in people with Type 1 Diabetes and Type 2 Diabetes, run by Consorzio Mario Negri Sud at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Needle for insulin pen, 4 mm long and with a diameter of 33 gauge and Needle for insulin pen, 4 mm long and with a diameter of 32 gauge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 4 sitesItaly
- Study dates
- Dec 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- incapacity for filling in the questionnaires
- every illness or condition that, according to the investigator, could interfere with the study
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
UO Diabetologia per Trattamento e Educazione dei Diabetici - Spedali Civili di Brescia
Brescia, BS, 25123
U.O.S. Diabetologia e Malattie Metaboliche - PO Cantù - Mariano Comense
Mariano Comense, CO, 22066
Struttura Complessa Dietologia-Diabetologia Malattie Metaboliche - Ospedale Pertini
Roma, RM, 00157
UO Malattie Metaboliche e Diabetologia - Ospedale di Treviglio-Caravaggio
Treviglio, BG, 24047
About this study
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
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.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Needle for insulin pen, 4 mm long and with a diameter of 33 gauge, Needle for insulin pen, 4 mm long and with a diameter of 32 gauge
- Keywords
- diabetes, insulin therapy, needle
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle for insulin pen, 4 mm long and with a diameter of 33 gaugeDevice
Needle for insulin pen, 4 mm long and with a diameter of 32 gaugeDevice
| Study group | Role | What they receive |
|---|---|---|
| needle 4 mm gauge 33 | Experimental | Needle for insulin pen, 4 mm long and with a diameter of 33 gauge (the smaller needle) Receives: Device: Needle for insulin pen, 4 mm long and with a diameter of 33 gauge |
| needle 4 mm gauge 32 | Active comparator | Needle for insulin pen, 4 mm long and with a diameter of 32 gauge Receives: Device: Needle for insulin pen, 4 mm long and with a diameter of 32 gauge |
What is being measured
The primary outcome is the main question the study is designed to answer.
hematic fructosamine levels
Measured: Change from baseline in fructosamine levels after 3 weeks of treatment
Secondary outcomes (7)
mean amplitude of glucose excursions (MAGE)
Measured: Change from baseline in MAGE after 3 weeks of treatment
pain
visual analogic scale (VAS) 1-10
Measured: questionnaire at the end of the treatments (at 6 weeks)
leakage at the site injection
visual scale
Measured: number of episodes of leakage during the treatment (3 weeks)
hypoglycemia
Measured: number of episodes of hypoglycemia during the treatment (3 weeks)
insulin dosage
Measured: Change from baseline in insulin dosage after 3 weeks of treatment
patient's weight
Measured: Change from baseline in weight after 3 weeks of treatment
patient's satisfaction
VAS scale
Measured: questionnaire at the end of the treatments (at 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorzio Mario Negri Sud
- Sponsor type
- University, hospital or other
- Collaborators
- Artsana S.p.a.
- Responsible party
- Principal investigator, Antonio Nicolucci, Consorzio Mario Negri Sud
- Investigators
- Antonio Nicolucci, MD, Study chair, Consorzio Mario Negri Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745549
- Sponsor's protocol ID
- AGO01
- Acronym
- AGO01
- Status last verified
- Mar 2014
- First submitted
- 5 Dec 2012
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Valentini M, Scardapane M, Bondanini F, Bossi A, Colatrella A, Girelli A, Ciucci A, Leotta S, Minotti E, Pasotti F, Pesenti A, Rocca L, Sciangula L, Vavassori E, Nicolucci A. Efficacy, safety and acceptability of the new pen needle 33G x 4 mm. AGO 01 study. Curr Med Res Opin. 2015 Mar;31(3):487-92. doi: 10.1185/03007995.2014.993025. Epub 2014 Dec 10.
PubMed 25469829
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01745549
- Acronym / sponsor ID
- AGO01 / AGO01
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- diabetes, insulin therapy, needle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Consorzio Mario Negri SudUniversity, hospital or other
- Collaborators
- Artsana S.p.a.
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| needle 4 mm gauge 33 | Experimental | Device: Needle for insulin pen, 4 mm long and with a diameter of 33 gaugeNeedle for insulin pen, 4 mm long and with a diameter of 33 gauge (the smaller needle) |
| needle 4 mm gauge 32 | Active comparator | Device: Needle for insulin pen, 4 mm long and with a diameter of 32 gaugeNeedle for insulin pen, 4 mm long and with a diameter of 32 gauge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- pregnancy
- incapacity for filling in the questionnaires
- every illness or condition that, according to the investigator, could interfere with the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needle for insulin pen, 4 mm long and with a diameter of 33 gauge | Device | needle 4 mm gauge 33 |
| Needle for insulin pen, 4 mm long and with a diameter of 32 gauge | Device | needle 4 mm gauge 32 |
Primary outcome
hematic fructosamine levels
Time frame: Change from baseline in fructosamine levels after 3 weeks of treatment
7 secondary outcomes
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)
leakage at the site injection
Time frame: number of episodes of leakage during the treatment (3 weeks)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
- Derived from this study: PubMed 25469829Valentini M, Scardapane M, Bondanini F, Bossi A, Colatrella A, Girelli A, Ciucci A, Leotta S, Minotti E, Pasotti F, Pesenti A, Rocca L, Sciangula L, Vavassori E, Nicolucci A. Efficacy, safety and acceptability of the new pen needle 33G x 4 mm. AGO 01 study. Curr Med Res Opin. 2015 Mar;31(3):487-92. doi: 10.1185/03007995.2014.993025. Epub 2014 Dec 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Nicolucci, MD study chair
Consorzio Mario Negri Sud
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needle for insulin pen, 4 mm long and with a diameter of 33 gauge and Needle for insulin pen, 4 mm long and with a diameter of 32 gauge in people with Type 1 Diabetes and Type 2 Diabetes, run by Consorzio Mario Negri Sud at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hematic fructosamine levels (time frame: Change from baseline in fructosamine levels after 3 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01745549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.