Observational Study Describing Conditions for Intensification of Insulin Therapy in Type 2 Diabetes

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00712478

Acronym

INTENSE3MIX

Enrollment

114

Registered

2008-07-10

Start date

2007-09-30

Completion date

2009-03-31

Last updated

2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief summary

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.

Interventions

DRUGinsulin

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Evaluate improvement of diabetes control with fasting glycemia and after diner glycemia measurements	After 3 months

Secondary

Measure	Time frame
Evaluate improvement of diabetes control with fasting glycemia and after diner glycemia measurements	After first 2 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026