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 A/S
ClinicalTrials.gov Identifier:
NCT00264901
First received: December 12, 2005
Last updated: June 26, 2012
Last verified: June 2012
  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:


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

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
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: NCT00264901

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

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

ClinicalTrials.gov processed this record on September 16, 2014