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Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes (PREDICTIVE™)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00264901
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in the United States of America (USA). This trial aims for a comparison of the safety and efficacy in subjects with type 2 diabetes using either self titration or physician guided titration according to the local standard of care.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5652 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of a Self-Adjusted Titration Guideline in Subjects With Type 2 Diabetes Mellitus: A Treat-to-Target of the Efficacy and Safety of Levemir® (Insulin Detemir [rDNA Origin] Injection) (PREDICTIVE™ 303)
Study Start Date : October 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Comparison of the change from baseline to end of treatment [ Time Frame: after 26 weeks in the value of laboratory-measured HbA1c between the self adjustment versus the standard of care group ]

Secondary Outcome Measures :
  1. Spontaneously reported adverse events during the trial
  2. Incidence of severe hypoglycaemic during the trial nocturnal (11 pm - 6 am)
  3. FPG during the trial (central laboratory) at Visit 2 and Visit 3
  4. Proportion of subjects achieving HbA1C <= 7.0% at Visit 2 and Visit 3
  5. Insulin detemir doses at Visit 2 and Visit 3
  6. Within-subject variation of before-breakfast SMPG values at Visit 2 and Visit 3


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of type 2 diabetes HbA1C <= 12.0% within the past 12 months;
  • BMI <= 45.0 kg/m2
  • Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator

Exclusion Criteria:

  • Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors.
  • Proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months.
  • Any glucose lowering medication that is not indicated in combination with insulin, such as GLP-1 Analogues
  • Known hypoglycemia unawareness or recurrent major hypoglycemia, as judged by the Investigator

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): NCT00264901


Locations
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United States, New Jersey
Novo Nordisk Investigational Site
Plainsboro, New Jersey, United States, 08536
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:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00264901    
Other Study ID Numbers: NN304-1720
First Posted: December 13, 2005    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs