NCT00712478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 10, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

June 30, 2008

Last Update Submit

October 31, 2023

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

    After 3 months

Secondary Outcomes (1)

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

    After first 2 months

Study Arms (1)

A

Drug: insulin

Interventions

insulinDRUG

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

A

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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%

You may not qualify if:

  • Patients not performing glycaemia self-measurements
  • Secondary diabetes
  • Requirement of or use of an insulin pump
  • Treatment with corticoids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Paris La Défense, 92936, France

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2008

First Posted

July 10, 2008

Study Start

September 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations

FR(1)