Initiation of Insulin Aspart in Type 2 Diabetes

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00572806
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate if using insulin aspart as start therapy will improve the efficacy on daytime blood glucose cycle profile in subjects with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02-05
• Primary Completion: 2004-02-02
• Study Completion: 2004-02-02
• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-13
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Type 2 diabetes for at least 3 years
• HbA1c greater than 8.0%
• Body Mass Index (BMI) below 40.0 kg/m2
• Inadequate treatment with diet and OADs
• Never received treatment with insulin

Exclusion Criteria

• Type 1 diabetes
• Known or suspected allergy to investigational product

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Blood glucose value	at 5 pm in a daytime blood glucose cycle profile

Secondary Outcome Measures

Name	Time	Method
HbA1c
Hypoglycaemic episodes
Evaluation of 24-hour blood glucose cycle

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇫🇷 MONTPELLIER cedex 5, France