NCT01745549

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

9 months

First QC Date

December 5, 2012

Last Update Submit

March 17, 2014

Conditions

Type 1 DiabetesType 2 Diabetes

Keywords

diabetesinsulin therapyneedle

Outcome Measures

Primary Outcomes (1)

  • hematic fructosamine levels

    Change from baseline in fructosamine levels after 3 weeks of treatment

Secondary Outcomes (7)

  • mean amplitude of glucose excursions (MAGE)

    Change from baseline in MAGE after 3 weeks of treatment

  • pain

    questionnaire at the end of the treatments (at 6 weeks)

  • leakage at the site injection

    number of episodes of leakage during the treatment (3 weeks)

  • hypoglycemia

    number of episodes of hypoglycemia during the treatment (3 weeks)

  • insulin dosage

    Change from baseline in insulin dosage after 3 weeks of treatment

  • +2 more secondary outcomes

Study Arms (2)

needle 4 mm gauge 33

EXPERIMENTAL

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

needle 4 mm gauge 32

ACTIVE COMPARATOR

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

Interventions

Needle for insulin pen, 4 mm long and with a diameter of 33 gaugeDEVICE
needle 4 mm gauge 33
Needle for insulin pen, 4 mm long and with a diameter of 32 gaugeDEVICE
needle 4 mm gauge 32

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy
  • incapacity for filling in the questionnaires
  • every illness or condition that, according to the investigator, could interfere with the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UO Malattie Metaboliche e Diabetologia - Ospedale di Treviglio-Caravaggio

Treviglio, BG, 24047, Italy

Location

UO Diabetologia per Trattamento e Educazione dei Diabetici - Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Location

U.O.S. Diabetologia e Malattie Metaboliche - PO Cantù - Mariano Comense

Mariano Comense, CO, 22066, Italy

Location

Struttura Complessa Dietologia-Diabetologia Malattie Metaboliche - Ospedale Pertini

Roma, RM, 00157, Italy

Location

Related Publications (1)

  • 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.

    PMID: 25469829DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Needles

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Antonio Nicolucci, MD

    Consorzio Mario Negri Sud

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Antonio Nicolucci, MD

Study Record Dates

First Submitted

December 5, 2012

First Posted

December 10, 2012

Study Start

December 1, 2012

Primary Completion

September 1, 2013

Study Completion

November 1, 2013

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

IT(4)