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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Paris La Défense, 92936, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin

Drug

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

Primary outcomes

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

Time frame: After 3 months

Secondary outcomes

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

Time frame: After first 2 months

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: INTENSE3MIX

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Jul 10, 2008
Registry last updated: Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed