Clinical trial

Observational Study on Efficacy of Intensification of Insulin Therapy to at Least 3 Daily Injections in Type 2 Diabetes

Name

BIASP-1866

Description

This study is conducted in Europe. The aim of this observational study is to determine diabetes control improvement, during the third month of follow-up after insulin intensification to at least 3 daily insulin injections, in assessing the proportion of uncontrolled fasting and postprandial glycaemia values recorded on a diary.

Trial arms

Trial start

2007-09-01

Estimated PCD

2009-03-01

Trial end

2009-03-01

Status

Completed

Treatment

insulin

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Arms:

Size

114

Primary endpoint

Evaluate improvement of diabetes control with fasting glycemia and after diner glycemia measurements

After 3 months

Eligibility criteria

Inclusion Criteria: * Type 2 diabetes patients * Treatment with two insulin daily injections and needing insulin intensification regimen to at least three daily injections * HbA1c greater than or equal to 8.0% Exclusion Criteria: * Patients not performing glycaemia self-measurements * Secondary diabetes * Requirement of or use of an insulin pump * Treatment with corticoids

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 114, 'type': 'ACTUAL'}}

Updated at

2023-11-02

1 organization

1 product

3 indications

Product

Indication

Indication

Indication

Organization