ClinicalTrials.gg
CompletedNCT00097877Updated Jan 11, 2017

Comparison of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Subjects With Type 2 Diabetes

A Phase 3 interventional study of biphasic insulin aspart and insulin glargine in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 73 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-11.

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

Phase
Phase 3
Study type
Interventional
Enrollment
293
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 test whether Biphasic Insulin Aspart 70/30 twice a day with Metformin improves glycemic control vs. once daily Insulin Glargine with Metformin in subjects with Type 2 Diabetes who are inadequately controlled on basal insulin plus oral anti-diabetic therapy.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2

Keywords

  • Type 2 Diabetes
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 293 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,400 studies on the registry; 102 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
293 participants (actual)
06

What researchers measure

Primary outcomes

  1. HbA1c

    Time frame: After 24 weeks

Secondary outcomes

  1. safety variables

  2. 8-point plasma glucose profile

  3. other glycemic variables

07

Study locations

73 sites
  • Novo Nordisk Investigational Site
    Birmingham, Alabama 35235, United States
  • Novo Nordisk Investigational Site
    Tuscaloosa, Alabama 35406, United States
  • Novo Nordisk Investigational Site
    Vestavia Hills, Alabama 35209, 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
    Fullerton, California 92835, United States
  • Novo Nordisk Investigational Site
    Orange, California 92868, United States
  • Novo Nordisk Investigational Site
    Orange, California 92869, United States
  • Novo Nordisk Investigational Site
    New Britain, Connecticut 06050, United States
  • Novo Nordisk Investigational Site
    Aventura, Florida 33180, United States
  • Novo Nordisk Investigational Site
    Chiefland, Florida 32626, United States
  • Novo Nordisk Investigational Site
    Fort Myers, Florida 33907, United States
  • Novo Nordisk Investigational Site
    Jacksonville, Florida 32208, United States
  • Novo Nordisk Investigational Site
    Melbourne, Florida 32901, United States
  • Novo Nordisk Investigational Site
    Ocala, Florida 34471, United States
  • Novo Nordisk Investigational Site
    Plantation, Florida 33324, United States
  • Novo Nordisk Investigational Site
    Atlanta, Georgia 30303, United States
  • Novo Nordisk Investigational Site
    Atlanta, Georgia 30339, United States
  • Novo Nordisk Investigational Site
    Boise, Idaho 83702, United States
  • Novo Nordisk Investigational Site
    Chicago, Illinois 60607, United States
  • Novo Nordisk Investigational Site
    New Albany, Indiana 47150, United States
  • Novo Nordisk Investigational Site
    Des Moines, Iowa 50314, United States
  • Novo Nordisk Investigational Site
    Overland Park, Kansas 66209, United States
  • Novo Nordisk Investigational Site
    Topeka, Kansas 66606, United States
  • Novo Nordisk Investigational Site
    Baton Rouge, Louisiana 70808, United States
  • Novo Nordisk Investigational Site
    Baltimore, Maryland 21204, United States
  • Novo Nordisk Investigational Site
    Springfield, Massachusetts 01107, United States
  • Novo Nordisk Investigational Site
    Chesterfield, Missouri 63017, United States
  • Novo Nordisk Investigational Site
    St Louis, Missouri 63017, United States
  • Novo Nordisk Investigational Site
    St Louis, Missouri 63141, United States
  • Novo Nordisk Investigational Site
    Omaha, Nebraska 68114, United States
  • Novo Nordisk Investigational Site
    Las Vegas, Nevada 89119-6100, United States
  • Novo Nordisk Investigational Site
    Cherry Hill, New Jersey 08034, United States
  • Novo Nordisk Investigational Site
    Lawrenceville, New Jersey 08648, United States
  • Novo Nordisk Investigational Site
    Plainsboro, New Jersey 08536, United States
  • Novo Nordisk Investigational Site
    New Hyde Park, New York 11042, United States
  • Novo Nordisk Investigational Site
    Staten Island, New York 10305, United States
  • Novo Nordisk Investigational Site
    Syracuse, New York 13210, United States
  • Novo Nordisk Investigational Site
    Greensboro, North Carolina 27408, United States
  • Novo Nordisk Investigational Site
    Dayton, Ohio 45406, United States
  • Novo Nordisk Investigational Site
    Dayton, Ohio 45439, United States
  • Novo Nordisk Investigational Site
    Kettering, Ohio 45429, United States
  • Novo Nordisk Investigational Site
    Clinton, Oklahoma 73601, United States
  • Novo Nordisk Investigational Site
    Tulsa, Oklahoma 74104, United States
  • Novo Nordisk Investigational Site
    Eugene, Oregon 97401, United States
  • Novo Nordisk Investigational Site
    Portland, Oregon 97239, United States
  • Novo Nordisk Investigational Site
    Salem, Oregon 97302, United States
  • Novo Nordisk Investigational Site
    Lancaster, Pennsylvania 17601, United States
  • Novo Nordisk Investigational Site
    Melrose Park, Pennsylvania 19027, United States
  • Novo Nordisk Investigational Site
    Norristown, Pennsylvania 19401, United States
  • Novo Nordisk Investigational Site
    West Reading, Pennsylvania 19611, United States
  • Novo Nordisk Investigational Site
    Greer, South Carolina 29651, United States
  • Novo Nordisk Investigational Site
    Memphis, Tennessee 38115, United States
  • Novo Nordisk Investigational Site
    Arlington, Texas 76014, United States
  • Novo Nordisk Investigational Site
    Dallas, Texas 75208, 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
    Lewisville, Texas 75067, United States
  • Novo Nordisk Investigational Site
    Midland, Texas 79707, United States
  • Novo Nordisk Investigational Site
    Plano, Texas 75074, 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
    Ogden, Utah 84403, 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
    Warrenton, Virginia 20186, United States
  • Novo Nordisk Investigational Site
    Bellevue, Washington 98004, United States
  • Novo Nordisk Investigational Site
    Milwaukee, Wisconsin 53209, United States
  • Novo Nordisk Investigational Site
    Manati, 00674, Puerto Rico
  • Novo Nordisk Investigational Site
    Santurce, 00907, Puerto Rico
08

References and documents

Publications

  • Ligthelm RJ, Gylvin T, DeLuzio T, Raskin P. A comparison of twice-daily biphasic insulin aspart 70/30 and once-daily insulin glargine in persons with type 2 diabetes mellitus inadequately controlled on basal insulin and oral therapy: a randomized, open-label study. Endocr Pract. 2011 Jan-Feb;17(1):41-50. doi: 10.4158/EP10079.OR. PubMed 20713345 ↗
  • Oyer DS, Shepherd MD, Coulter FC, Bhargava A, Deluzio AJ, Chu PL, Trippe BS; Initiateplus Study Group. Efficacy and tolerability of self-titrated biphasic insulin aspart 70/30 in patients aged >65 years with type 2 diabetes: an exploratory post hoc subanalysis of the INITIATEplus trial. Clin Ther. 2011 Jul;33(7):874-83. doi: 10.1016/j.clinthera.2011.05.093. Epub 2011 Jul 8. PubMed 21741089 ↗
  • Trippe BS, Shepherd MD, Coulter FC, Bhargava A, Brett J, Chu PL, Oyer DS. Efficacy and safety of biphasic insulin aspart 70/30 in type 2 diabetes patients of different race or ethnicity (INITIATEplus trial). Curr Med Res Opin. 2012 Jul;28(7):1203-11. doi: 10.1185/03007995.2012.686444. Epub 2012 Jun 25. PubMed 22509859 ↗
  • Bergenstal R, Lewin A, Bailey T, Chang D, Gylvin T, Roberts V; NovoLog Mix-vs.-Exenatide Study Group. Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea. Curr Med Res Opin. 2009 Jan;25(1):65-75. doi: 10.1185/03007990802597951. PubMed 19210140 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2005, a primary completion of Nov 2006 and a completion of Nov 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2004
First posted
Dec 1, 2004
Start
Jan 2005
Primary completionActual
Nov 2006
CompletionActual
Nov 2006
Last update
Jan 11, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00097877
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 1, 2004
Start date
Jan 2005
Primary completion
Nov 2006
Completion
Nov 2006
Last update
Jan 11, 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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Insulin Aspart · Insulin Glargine

Start the discussion