Localisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long Needles

Phase 3

Completed

• Conditions: Delivery Systems; Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

• Registration Number: NCT00871416
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The primary aim of this clinical trial is to locate and compare simulated insulin injections (injections of sterile atmospheric air) in normal weight and obese patients with diabetes mellitus. Injections are done with 6 mm and 12 mm needles with and without lifting of skin fold at different injection sites.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-04-09
• Primary Completion: 1997-07-18
• Study Completion: 1997-07-18
• Study First Submitted: 2009-03-27
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-30
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Diabetes mellitus
• Use NovoPen®, NovoPen® 1.5, NovoPen® 3, NovoLet® 1.5 or NovoLet® 3 for at least 3 months
• Body mass index (BMI) for normal weight between 19-25 kg/m2
• Body mass index (BMI) for obese between 25-33 kg/m2

Exclusion Criteria

• Pregnancy or plans thereof
• Local reactions on injection sites
• Acute, severe infection diseases
• Coagulation disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Location of the injected sterile, atmospheric air	after 4 injections at visit 1 and 2, respectively

Secondary Outcome Measures

Name	Time	Method
Cutis/subcutis thickness on 14 recommended injection sites

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇰 Århus, Denmark