CClinicalTrials.gg
CompletedNCT00106366Updated Jan 31, 2017

Comparison of Insulin Detemir With Insulin Glargine in Type 2 Diabetes

A Phase 3 interventional study of insulin detemir and insulin glargine in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 78 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-31.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
389
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This trial is conducted in the United States of America (USA). The purpose of this study is to determine if the use of insulin detemir in combination with insulin aspart is safe and at least as effective as insulin glargine in combination with insulin aspart for the control of blood glucose in patients with Type 2 diabetes.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2

Keywords

  • Diabetes, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 389 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Type 2 Diabetes for more than 12 months
  • Currently treated with glucose lowering tablets or insulin
  • HbA1c: 7.0-12.0%
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
389 participants (actual)

Interventions

  • Druginsulin detemir
  • Druginsulin glargine
  • Druginsulin aspart
06

What researchers measure

Primary outcomes

  1. HbA1c

    Time frame: after 26 weeks

Secondary outcomes

  1. Body weight

  2. Glucose profiles

07

Study locations

78 sites
  • Novo Nordisk Investigational Site
    Birmingham, Alabama 35235, United States
  • Novo Nordisk Investigational Site
    Vestavia, Alabama 35209, United States
  • Novo Nordisk Investigational Site
    Little Rock, Arkansas 72204, United States
  • Novo Nordisk Investigational Site
    Searcy, Arkansas 72143, United States
  • Novo Nordisk Investigational Site
    Chula Vista, California 91911, United States
  • Novo Nordisk Investigational Site
    Concord, California 94520, United States
  • Novo Nordisk Investigational Site
    Inglewood, California 90301, United States
  • Novo Nordisk Investigational Site
    Los Angeles, California 90057, United States
  • Novo Nordisk Investigational Site
    Orange, California 92868, United States
  • Novo Nordisk Investigational Site
    Santa Ana, California 92705, United States
  • Novo Nordisk Investigational Site
    Santa Barbara, California 93105, United States
  • Novo Nordisk Investigational Site
    Santa Monica, California 90404, United States
  • Novo Nordisk Investigational Site
    Aurora, Colorado 80045, United States
  • Novo Nordisk Investigational Site
    Longmont, Colorado 80501, United States
  • Novo Nordisk Investigational Site
    Newark, Delaware 19702, United States
  • Novo Nordisk Investigational Site
    Aventura, Florida 33180, United States
  • Novo Nordisk Investigational Site
    Delray Beach, Florida 33484, United States
  • Novo Nordisk Investigational Site
    Lake Mary, Florida 32746, United States
  • Novo Nordisk Investigational Site
    Longwood, Florida 32779, United States
  • Novo Nordisk Investigational Site
    Ocala, Florida 34471, United States
  • Novo Nordisk Investigational Site
    Orlando, Florida 32804, United States
  • Novo Nordisk Investigational Site
    Plantation, Florida 33324, United States
  • Novo Nordisk Investigational Site
    West Palm Beach, Florida 33407, United States
  • Novo Nordisk Investigational Site
    Atlanta, Georgia 30032, United States
  • Novo Nordisk Investigational Site
    Atlanta, Georgia 30318, United States
  • Novo Nordisk Investigational Site
    Powder Springs, Georgia 30127, United States
  • Novo Nordisk Investigational Site
    Idaho Falls, Idaho 83404-7596, United States
  • Novo Nordisk Investigational Site
    Chicago, Illinois 60607, United States
  • Novo Nordisk Investigational Site
    Springfield, Illinois 62711, United States
  • Novo Nordisk Investigational Site
    Des Moines, Iowa 50314, United States
  • Novo Nordisk Investigational Site
    Topeka, Kansas 66606, United States
  • Novo Nordisk Investigational Site
    Baltimore, Maryland 21204, United States
  • Novo Nordisk Investigational Site
    St. Paul, Minnesota 55108, United States
  • Novo Nordisk Investigational Site
    Kansas City, Missouri 64114, United States
  • Novo Nordisk Investigational Site
    St. Louis, Missouri 63141, United States
  • Novo Nordisk Investigational Site
    Las Vegas, Nevada 89102, United States
  • Novo Nordisk Investigational Site
    Reno, Nevada 89502-0111, United States
  • Novo Nordisk Investigational Site
    Berlin, New Jersey 08009, United States
  • Novo Nordisk Investigational Site
    Lawrenceville, New Jersey 08648, United States
  • Novo Nordisk Investigational Site
    West Seneca, New York 14224, United States
  • Novo Nordisk Investigational Site
    Asheville, North Carolina 28801, United States
  • Novo Nordisk Investigational Site
    Greensboro, North Carolina 27408, United States
  • Novo Nordisk Investigational Site
    Monroe, North Carolina 28204, United States
  • Novo Nordisk Investigational Site
    Raleigh, North Carolina 27609, United States
  • Novo Nordisk Investigational Site
    Canton, Ohio 44718, United States
  • Novo Nordisk Investigational Site
    Franklin, Ohio 45005, United States
  • Novo Nordisk Investigational Site
    Kettering, Ohio 45429, United States
  • Novo Nordisk Investigational Site
    Mentor, Ohio 44060, United States
  • Novo Nordisk Investigational Site
    Clinton, Oklahoma 73601, United States
  • Novo Nordisk Investigational Site
    Tulsa, Oklahoma 74104, United States
  • Novo Nordisk Investigational Site
    Medford, Oregon 97504, United States
  • Novo Nordisk Investigational Site
    Duncan, South Carolina 29334, United States
  • Novo Nordisk Investigational Site
    Chattanooga, Tennessee 37404, United States
  • Novo Nordisk Investigational Site
    Arlington, Texas 76014, United States
  • Novo Nordisk Investigational Site
    Dallas, Texas 75230, United States
  • Novo Nordisk Investigational Site
    Dallas, Texas 75231, United States
  • Novo Nordisk Investigational Site
    Dallas, Texas 75246, United States
  • Novo Nordisk Investigational Site
    Dallas, Texas 75390-8858, United States
  • Novo Nordisk Investigational Site
    Houston, Texas 77030, United States
  • Novo Nordisk Investigational Site
    Midland, Texas 79707, United States
  • Novo Nordisk Investigational Site
    Plano, Texas 75093, United States
  • Novo Nordisk Investigational Site
    San Antonio, Texas 78229, United States
  • Novo Nordisk Investigational Site
    Newport News, Virginia 23606, United States
  • Novo Nordisk Investigational Site
    Richmond, Virginia 23249, United States
  • Novo Nordisk Investigational Site
    Richmond, Virginia 23294, United States
  • Novo Nordisk Investigational Site
    Olympia, Washington 98502, United States
  • Novo Nordisk Investigational Site
    Renton, Washington 98057, United States
  • Novo Nordisk Investigational Site
    Tacoma, Washington 98405, United States
  • Novo Nordisk Investigational Site
    Calgary, Alberta T2H 2G4, Canada
  • Novo Nordisk Investigational Site
    Halifax, Nova Scotia B3H 1V7, Canada
  • Novo Nordisk Investigational Site
    Toronto, Ontario M5C 2T2, Canada
  • Novo Nordisk Investigational Site
    Laval, Quebec H7T 2P5, Canada
  • Novo Nordisk Investigational Site
    London, N6A 5A5, Canada
  • Novo Nordisk Investigational Site
    Mississauga, L5M 2V8, Canada
  • Novo Nordisk Investigational Site
    Montreal, H3A 1A1, Canada
  • Novo Nordisk Investigational Site
    Ste-Foy, G1V 4G5, Canada
  • Novo Nordisk Investigational Site
    Thornhill, L4J 8L7, Canada
  • Novo Nordisk Investigational Site
    Rio Piedras, 00921, Puerto Rico
08

References and documents

Publications

  • Raskin P, Gylvin T, Weng W, Chaykin L. Comparison of insulin detemir and insulin glargine using a basal-bolus regimen in a randomized, controlled clinical study in patients with type 2 diabetes. Diabetes Metab Res Rev. 2009 Sep;25(6):542-8. doi: 10.1002/dmrr.989. PubMed 19565569 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00106366
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Mar 23, 2005
Start date
Mar 2005
Primary completion
Dec 2005
Completion
Dec 2005
Last update
Jan 31, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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