Effect of Two Different Fasting Blood Glucose Targets on Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily (TITRATE™)

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

Effect of Two Different Fasting Blood Glucose Titration Targets in Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily in Combination With 1-3 Oral Agents

This trial is conducted in the United States of America. The aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

244

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

  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Novo Nordisk Investigational Site
      • San Juan, Puerto Rico, 00921
        • Novo Nordisk Investigational Site
      • Trujillo Alto, Puerto Rico, 00976
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85395
        • Novo Nordisk Investigational Site
      • Scottsdale, Arizona, United States, 85251-5638
        • Novo Nordisk Investigational Site
    • Arkansas
      • Searcy, Arkansas, United States, 72143
        • Novo Nordisk Investigational Site
    • California
      • Artesia, California, United States, 90701
        • Novo Nordisk Investigational Site
      • Escondido, California, United States, 92025
        • Novo Nordisk Investigational Site
      • Fullerton, California, United States, 92835-3404
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90036
        • Novo Nordisk Investigational Site
      • Orange, California, United States, 92869
        • Novo Nordisk Investigational Site
      • Spring Valley, California, United States, 91978
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Colorado
      • Parker, Colorado, United States, 80138-8789
        • Novo Nordisk Investigational Site
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • Novo Nordisk Investigational Site
      • Prospect, Connecticut, United States, 06712
        • Novo Nordisk Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33433
        • Novo Nordisk Investigational Site
      • Clearwater, Florida, United States, 33755-2138
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32204
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32205
        • Novo Nordisk Investigational Site
      • Lake Mary, Florida, United States, 32746
        • Novo Nordisk Investigational Site
      • Plantation, Florida, United States, 33324
        • Novo Nordisk Investigational Site
    • Georgia
      • Athens, Georgia, United States, 30606
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
      • Savannah, Georgia, United States, 31406
        • Novo Nordisk Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
    • Indiana
      • Terre Haute, Indiana, United States, 47802
        • Novo Nordisk Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Novo Nordisk Investigational Site
    • Maryland
      • Pikesville, Maryland, United States, 21208-3737
        • Novo Nordisk Investigational Site
    • Minnesota
      • St. Paul, Minnesota, United States, 55108
        • Novo Nordisk Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017-3632
        • Novo Nordisk Investigational Site
      • St. Louis, Missouri, United States, 63141
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Novo Nordisk Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Novo Nordisk Investigational Site
      • Camden, New Jersey, United States, 08104
        • Novo Nordisk Investigational Site
      • Lawrenceville, New Jersey, United States, 08648
        • Novo Nordisk Investigational Site
    • New York
      • New York, New York, United States, 10023
        • Novo Nordisk Investigational Site
      • Staten Island, New York, United States, 10301
        • Novo Nordisk Investigational Site
      • West Seneca, New York, United States, 14224
        • Novo Nordisk Investigational Site
    • North Carolina
      • Shelby, North Carolina, United States, 28152
        • Novo Nordisk Investigational Site
      • Statesville, North Carolina, United States, 28625
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45439
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45406
        • Novo Nordisk Investigational Site
      • Mentor, Ohio, United States, 44060
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novo Nordisk Investigational Site
      • Norristown, Pennsylvania, United States, 19401
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Novo Nordisk Investigational Site
      • Taylors, South Carolina, United States, 29687
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
      • Chattanooga, Tennessee, United States, 37411
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, United States, 76014
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-9302
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77024
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77025
        • Novo Nordisk Investigational Site
      • Midland, Texas, United States, 79707
        • Novo Nordisk Investigational Site
      • Odessa, Texas, United States, 79761
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78209
        • Novo Nordisk Investigational Site
    • Washington
      • Spokane, Washington, United States, 99218
        • Novo Nordisk Investigational Site
      • Spokane, Washington, United States, 99204-2629
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • 1-3 oral treatments
  • Insulin naive
  • BMI (Body Mass Index) less than or equal to 45

Exclusion Criteria:

  • Pregnancy
  • Retinopathy
  • Cardiac disease
  • Uncontrolled hypertension
  • Recurrent hypoglycaemia

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FPG 70-90 mg/dL
Aggressive FPG (fasting plasma glucose) titration target range group
Drug: insulin detemir
Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL
Drug: insulin detemir
Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL
Experimental: FPG 80-110 mg/dL
Conventional FPG (fasting plasma glucose) titration target range group
Drug: insulin detemir
Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL
Drug: insulin detemir
Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%
Time Frame: week 20
Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment
week 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%
Time Frame: week 20
Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment
week 20
Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline
Time Frame: week -2, week 20
Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20
week -2, week 20
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Time Frame: weeks 0-20

Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows:

  • If subject was unable to treat himself: Major incidence.
  • If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence.
  • If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only.
weeks 0-20

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

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

February 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

March 6, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-3502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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