Comparison of Glycemic Control Achieved With 2 Different Needles

Phase 4CompletedNCT00572052

Novo Nordisk A/S62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

NovoFine® needle 6 mmDEVICE

Ultra-Fine needle 12.7 mmDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (5)

Novo Nordisk Investigational Site

Walnut Creek, California, United States

Novo Nordisk Investigational Site

Berlin, New Jersey, United States

Novo Nordisk Investigational Site

Lawrenceville, New Jersey, United States

Novo Nordisk Investigational Site

Kettering, Ohio, United States

Outcomes

Primary Outcomes

HbA1c

Time frame: after 12 weeks of treatment

Secondary Outcomes

Subject preference and handling

Frequency of hypoglycaemic episodes

Quality of Life

Data from ClinicalTrials.gov

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