Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart | Drug | |||
| insulin glargine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | After 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| safety variables | ||
| 8-point plasma glucose profile | ||
| other glycemic variables |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Birmingham | Alabama | 35235 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20713345 | Result | 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. | |
| 21741089 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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. |
| 22509859 | Result | 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. |
| 19210140 | Derived | 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. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided