NCT00264901

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,652

participants targeted

Target at P75+ for phase_4 diabetes

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

December 12, 2005

Last Update Submit

January 30, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Comparison of the change from baseline to end of treatment

    after 26 weeks in the value of laboratory-measured HbA1c between the self adjustment versus the standard of care group

Secondary Outcomes (6)

  • Spontaneously reported adverse events during the trial

  • Incidence of severe hypoglycaemic during the trial nocturnal (11 pm - 6 am)

  • FPG during the trial (central laboratory) at Visit 2 and Visit 3

  • Proportion of subjects achieving HbA1C <= 7.0% at Visit 2 and Visit 3

  • Insulin detemir doses at Visit 2 and Visit 3

  • +1 more secondary outcomes

Interventions

insulin detemirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Plainsboro, New Jersey, 08536, United States

Location

Related Publications (3)

  • Meneghini L, Koenen C, Weng W, Selam JL. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes--results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab. 2007 Nov;9(6):902-13. doi: 10.1111/j.1463-1326.2007.00804.x.

    PMID: 17924873RESULT

  • Selam JL, Koenen C, Weng W, Meneghini L. Improving glycemic control with insulin detemir using the 303 Algorithm in insulin naive patients with type 2 diabetes: a subgroup analysis of the US PREDICTIVE 303 study. Curr Med Res Opin. 2008 Jan;24(1):11-20. doi: 10.1185/030079908x242755.

    PMID: 18021495RESULT

  • Bhargava A, Chan V, Kimball ES, Oyer DS. Effects of Age on Glycemic Control in Patients With Type 2 Diabetes Treated with Insulin Detemir: A Post-Hoc Analysis of the PREDICTIVE 303 Study. Drugs Aging. 2016 Feb;33(2):135-41. doi: 10.1007/s40266-016-0342-9.

    PMID: 26833348RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2005

First Posted

December 13, 2005

Study Start

October 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

US(1)