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

January 30, 2017 updated by: Novo Nordisk A/S

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: insulin detemir

Study Type

Interventional

Enrollment (Actual)

5652

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New Jersey
  - Plainsboro, New Jersey, United States, 08536
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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
Within-subject variation of before-breakfast SMPG values at Visit 2 and Visit 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)