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

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ClinicalTrials.gov Identifier: NCT00712478
Recruitment Status : Completed
First Posted : July 10, 2008
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: insulin

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Study Type : Observational
Actual Enrollment : 114 participants
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
Study Start Date : September 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Evaluate improvement of diabetes control with fasting glycemia and after diner glycemia measurements [ Time Frame: After 3 months ]

Secondary Outcome Measures :
  1. Evaluate improvement of diabetes control with fasting glycemia and after diner glycemia measurements [ Time Frame: After first 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712478


Locations
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France
Paris La Défense, France, 92936
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00712478     History of Changes
Other Study ID Numbers: BIASP-1866
First Posted: July 10, 2008    Key Record Dates
Last Update Posted: March 7, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs