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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00264901
First received: December 12, 2005
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: insulin detemir
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Spontaneously reported adverse events during the trial [ Designated as safety issue: Yes ]
  • Incidence of severe hypoglycaemic during the trial nocturnal (11 pm - 6 am) [ Designated as safety issue: Yes ]
  • FPG during the trial (central laboratory) at Visit 2 and Visit 3 [ Designated as safety issue: No ]
  • Proportion of subjects achieving HbA1C <= 7.0% at Visit 2 and Visit 3 [ Designated as safety issue: No ]
  • Insulin detemir doses at Visit 2 and Visit 3 [ Designated as safety issue: No ]
  • Within-subject variation of before-breakfast SMPG values at Visit 2 and Visit 3 [ Designated as safety issue: No ]

Enrollment: 5652
Study Start Date: October 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264901

  Show 1134 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Christoph Koenen, MD Novo Nordisk
  More Information

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

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00264901     History of Changes
Other Study ID Numbers: NN304-1720
Study First Received: December 12, 2005
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013