Initiation of Insulin Aspart in Type 2 Diabetes

February 22, 2017 updated by: Novo Nordisk A/S

Evaluation of the Initiation of Insulin Treatment Using Insulin Aspart on Blood Glucose Profile in Type 2 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: insulin aspart

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - MONTPELLIER cedex 5, France, 34295
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood glucose value Time Frame: at 5 pm in a daytime blood glucose cycle profile	at 5 pm in a daytime blood glucose cycle profile

Secondary Outcome Measures

Outcome Measure
HbA1c
Evaluation of 24-hour blood glucose cycle
Hypoglycaemic episodes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2003

Primary Completion (Actual)

February 2, 2004

Study Completion (Actual)