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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
biphasic insulin aspart
insulin glargine
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Type 2 Diabetes

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

safety variables
8-point plasma glucose profile
other glycemic variables

Full Information

First Posted
November 30, 2004
Last Updated
January 10, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00097877
Brief Title
Comparison of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Subjects With Type 2 Diabetes
Official Title
Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Combination With Metformin in Subjects With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
Keywords
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
293 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
After 24 weeks
Secondary Outcome Measure Information:
Title
safety variables
Title
8-point plasma glucose profile
Title
other glycemic variables

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 Diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Vestavia
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32208
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119-6100
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Clinton
State/Province
Oklahoma
ZIP/Postal Code
73601
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Salem
State/Province
Oregon
ZIP/Postal Code
97302
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Melrose Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38115
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8858
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75067
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Midland
State/Province
Texas
ZIP/Postal Code
79707
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75074
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Warrenton
State/Province
Virginia
ZIP/Postal Code
20186
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Manati
ZIP/Postal Code
00674
Country
Puerto Rico
Facility Name
Novo Nordisk Investigational Site
City
Santurce
ZIP/Postal Code
00907
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
20713345
Citation
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.
Results Reference
result
PubMed Identifier
21741089
Citation
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.
Results Reference
result
PubMed Identifier
22509859
Citation
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.
Results Reference
result
PubMed Identifier
19210140
Citation
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.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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