Diabetes Mellitus, Type 2 Clinical Trial
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
| Verified date | January 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 293 |
| Est. completion date | November 2006 |
| Est. primary completion date | November 2006 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type 2 Diabetes |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Novo Nordisk Investigational Site | Manati | |
| Puerto Rico | Novo Nordisk Investigational Site | Santurce | |
| United States | Novo Nordisk Investigational Site | Arlington | Texas |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Aventura | Florida |
| United States | Novo Nordisk Investigational Site | Baltimore | Maryland |
| United States | Novo Nordisk Investigational Site | Baton Rouge | Louisiana |
| United States | Novo Nordisk Investigational Site | Bellevue | Washington |
| United States | Novo Nordisk Investigational Site | Birmingham | Alabama |
| United States | Novo Nordisk Investigational Site | Boise | Idaho |
| United States | Novo Nordisk Investigational Site | Cherry Hill | New Jersey |
| United States | Novo Nordisk Investigational Site | Chesterfield | Missouri |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Chiefland | Florida |
| United States | Novo Nordisk Investigational Site | Chula Vista | California |
| United States | Novo Nordisk Investigational Site | Clinton | Oklahoma |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dayton | Ohio |
| United States | Novo Nordisk Investigational Site | Dayton | Ohio |
| United States | Novo Nordisk Investigational Site | Des Moines | Iowa |
| United States | Novo Nordisk Investigational Site | Eugene | Oregon |
| United States | Novo Nordisk Investigational Site | Fort Myers | Florida |
| United States | Novo Nordisk Investigational Site | Fullerton | California |
| United States | Novo Nordisk Investigational Site | Greensboro | North Carolina |
| United States | Novo Nordisk Investigational Site | Greer | South Carolina |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Kettering | Ohio |
| United States | Novo Nordisk Investigational Site | Lancaster | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Lawrenceville | New Jersey |
| United States | Novo Nordisk Investigational Site | Lewisville | Texas |
| United States | Novo Nordisk Investigational Site | Melbourne | Florida |
| United States | Novo Nordisk Investigational Site | Melrose Park | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Memphis | Tennessee |
| United States | Novo Nordisk Investigational Site | Midland | Texas |
| United States | Novo Nordisk Investigational Site | Milwaukee | Wisconsin |
| United States | Novo Nordisk Investigational Site | New Albany | Indiana |
| United States | Novo Nordisk Investigational Site | New Britain | Connecticut |
| United States | Novo Nordisk Investigational Site | New Hyde Park | New York |
| United States | Novo Nordisk Investigational Site | Newport News | Virginia |
| United States | Novo Nordisk Investigational Site | Norristown | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Ocala | Florida |
| United States | Novo Nordisk Investigational Site | Ogden | Utah |
| United States | Novo Nordisk Investigational Site | Omaha | Nebraska |
| United States | Novo Nordisk Investigational Site | Orange | California |
| United States | Novo Nordisk Investigational Site | Orange | California |
| United States | Novo Nordisk Investigational Site | Overland Park | Kansas |
| United States | Novo Nordisk Investigational Site | Plainsboro | New Jersey |
| United States | Novo Nordisk Investigational Site | Plano | Texas |
| United States | Novo Nordisk Investigational Site | Plano | Texas |
| United States | Novo Nordisk Investigational Site | Plantation | Florida |
| United States | Novo Nordisk Investigational Site | Portland | Oregon |
| United States | Novo Nordisk Investigational Site | Richmond | Virginia |
| United States | Novo Nordisk Investigational Site | Salem | Oregon |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | Searcy | Arkansas |
| United States | Novo Nordisk Investigational Site | Springfield | Massachusetts |
| United States | Novo Nordisk Investigational Site | St. Louis | Missouri |
| United States | Novo Nordisk Investigational Site | St. Louis | Missouri |
| United States | Novo Nordisk Investigational Site | Staten Island | New York |
| United States | Novo Nordisk Investigational Site | Syracuse | New York |
| United States | Novo Nordisk Investigational Site | Topeka | Kansas |
| United States | Novo Nordisk Investigational Site | Tulsa | Oklahoma |
| United States | Novo Nordisk Investigational Site | Tuscaloosa | Alabama |
| United States | Novo Nordisk Investigational Site | Vestavia | Alabama |
| United States | Novo Nordisk Investigational Site | Warrenton | Virginia |
| United States | Novo Nordisk Investigational Site | West Reading | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Puerto Rico,
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-la — View 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 suban — View 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: — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c | After 24 weeks | No | |
| Secondary | safety variables | No | ||
| Secondary | 8-point plasma glucose profile | No | ||
| Secondary | other glycemic variables | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
| Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
| Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
| Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
| Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
| Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
| Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
| Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
| Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
| Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
| Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
| Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
| Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
| Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
| Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
| Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
| Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
| Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
| Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
| Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |