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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00712478
First received: June 30, 2008
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
 Drug: insulin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on Efficacy of Intensification of Insulin Therapy to at Least 3 Daily Injections in Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Evaluate improvement of diabetes control with fasting glycemia and after diner glycemia measurements [ Time Frame: After 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate improvement of diabetes control with fasting glycemia and after diner glycemia measurements [ Time Frame: After first 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 114
Study Start Date: September 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712478

Locations
France
Paris La Défense, France, 92936
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Luminita Spinu Novo Nordisk Pharmaceutique SAS
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00712478     History of Changes
Other Study ID Numbers: BIASP-1866
Study First Received: June 30, 2008
Last Updated: June 15, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013