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 A/S
ClinicalTrials.gov Identifier:
NCT00712478
First received: June 30, 2008
Last updated: June 15, 2012
Last verified: June 2012
  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:


Further study details as provided by Novo Nordisk A/S:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014