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NovoFine needle 6 mm, NovoFine needle 4 mm

Phase 3

Diabetes | Unknown | Metabolic |Novo Nordisk A/S|Last Updated: Aug 7, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials3
Total Enrollment170

FDA Designations

No designations recorded

Clinical trial landscape

NovoFine needle 6 mm, NovoFine needle 4 mm · 3 trials · 4 indications

Phase 3 2Phase 2 1
NCT00872560Comparison of 2 NovoFine® Needles on the Reflux of InsulinDiabetes
COMPLETED60 Analytics
NCT00871416Localisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long NeedlesDiabetes
COMPLETED48 Analytics
PHASE3COMPLETED
Comparison of 2 NovoFine® Needles on the Reflux of Insulin
DiabetesUnlock trial analytics
PHASE3COMPLETED
Localisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long Needles
DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Weighing of reflux of insulin
6 seconds after injection
Location of the injected sterile, atmospheric air
after 4 injections at visit 1 and 2, respectively
Deposition of sterile air depositions.

Secondary Endpoints

Pain perception
after 6 weeks of treatment
Number and severity of bleedings
after 6 weeks of treatment
Reactions at injection sites
after 6 weeks of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
NovoFine® needle 6 mmDEVICE -
NovoFine® needle 8 mmDEVICE -
NovoFine® needle 12 mmDEVICE -
NovoFine® needle 4 mmDEVICE -
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Eligibility Criteria

Age Range10 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Children/adolescents with type 1 diabetes mellitus * Usage of NovoPen® 1.5 for at least 3 months * Duration of insulin treatment more than 1 year * Normal weight according to Tanner scales * The means of the last 2 HbA1c measurements taken within the last 6 months must be less...

Countries:ItalyDenmark
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Competitive Landscape -Diabetes Complications 6 trials (matched to "Diabetes")

Frequently asked questions about NovoFine needle 6 mm, NovoFine needle 4 mm

What is NovoFine needle 6 mm and NovoFine needle 4 mm used for?

NovoFine needle 6 mm and NovoFine needle 4 mm are insulin pen needles used for insulin delivery in people with diabetes, including type 1 and type 2 diabetes. They are designed to attach to insulin pens and are available in different lengths to accommodate various body types and injection sites.

Who makes NovoFine needle 6 mm and NovoFine needle 4 mm?

NovoFine needle 6 mm and NovoFine needle 4 mm are developed by Novo Nordisk A/S, a Danish pharmaceutical company listed on the New York Stock Exchange under the ticker NVO. Novo Nordisk specializes in diabetes care and produces a range of insulin delivery devices.

What phase is NovoFine needle 6 mm and NovoFine needle 4 mm in?

NovoFine needle 6 mm and NovoFine needle 4 mm are in Phase 3 clinical development. They are investigational devices being studied for use in diabetes management. They are not yet approved by regulatory authorities and remain in clinical trials.

What clinical trials is NovoFine needle 6 mm and NovoFine needle 4 mm in?

NovoFine needle 6 mm and NovoFine needle 4 mm have been studied in three completed clinical trials: NCT00343343 compared 4 mm and 6 mm needles in 62 participants in Denmark; NCT00871416 examined insulin deposits with 6 mm and 12 mm needles in 48 participants; and NCT00872560 compared two NovoFine needles on insulin reflux in 60 participants in Italy.

Is NovoFine needle 6 mm the same as NovoFine needle 4 mm?

NovoFine needle 6 mm and NovoFine needle 4 mm are both insulin pen needles from the same product line, but they differ in length. The 6 mm needle is longer than the 4 mm needle. They are designed for subcutaneous insulin injection and are compared in clinical trials to assess their performance.