Observational Study Describing Conditions for Intensification of Insulin Therapy in Type 2 Diabetes (INTENSE3MIX)

October 31, 2023 updated by: Novo Nordisk A/S

Observational Study on Efficacy of Intensification of Insulin Therapy to at Least 3 Daily Injections 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

114

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
      • Paris La Défense, France, 92936

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Men and women aged 40 years old and more with type 2 diabetes

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: insulin
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), 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

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

September 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

June 30, 2008

First Submitted That Met QC Criteria

July 9, 2008

First Posted (Estimated)

July 10, 2008

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1866

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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