Comparison of Glycemic Control Achieved With 2 Different Needles

Comparison of Glycemic Control Achieved With a 31 Gauge x 6 mm NovoFine® Needle vs. a BD 29 Gauge x 12.7 mm Ultra-Fine® Needle in Subjects With Diabetes Mellitus and a BMI Exceeding 30 kg/m2: An Open Label, Randomized, Two-Period Crossover Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00572052

Enrollment

Registered

2007-12-12

Start date

2002-12-31

Completion date

2003-10-31

Last updated

2017-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery Systems, Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Brief summary

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate if a 31 gauge x 6 mm needle will provide comparable blood glucose control to the 29 gauge x 12.7 mm needle in obese subjects with diabetes.

Interventions

DEVICENovoFine® needle 6 mm

DEVICEUltra-Fine needle 12.7 mm

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Diabetes mellitus * Current treatment with insulin or insulin analogues for the last 6 months * BMI greater than or equal to 30.0 kg/m2 * Currently injecting in the thigh or abdomen * HbA1c below 10%

Exclusion criteria

* Severe, uncontrolled hypertension * Self-mixing insulin * Unwillingness to monitor blood glucose * Pregnancy, breast-feeding, intention to become pregnant, or inadequate contraceptive measures

Design outcomes

Primary

Measure	Time frame
HbA1c	after 12 weeks of treatment

Secondary

Measure	Time frame
Subject preference and handling	—
Frequency of hypoglycaemic episodes	—
Quality of Life	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026