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Completed

NCT Number: NCT00264901

Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site

Plainsboro, New Jersey, 08536, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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)

Acronym: PREDICTIVE™

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Dec 13, 2005
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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