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.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline

Completed

Started Dec 2002

Shorter than P25 for phase_4 diabetes

Geographic Reach

1 country

5 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

10 months study duration

Study Start

First participant enrolled

December 1, 2002

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed

4.2 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed

8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed

Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

December 4, 2007

Last Update Submit

January 18, 2017

Conditions

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

Outcome Measures

Primary Outcomes (1)

HbA1c
after 12 weeks of treatment

Secondary Outcomes (3)

Subject preference and handling
Frequency of hypoglycaemic episodes
Quality of Life

Interventions

NovoFine® needle 6 mmDEVICE

Ultra-Fine needle 12.7 mmDEVICE

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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%

You may not qualify if:

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

Contact the study team to confirm eligibility.