| Trial ID: | L7287 |
| Source ID: | NCT00101751
|
| Associated Drug: |
Biphasic Insulin Aspart
|
| Title: |
INITIATE Plus (INITiation of Insulin to Reach A1c TargEt) Study
|
| Acronym: |
INITIATE plus
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: biphasic insulin aspart|BEHAVIORAL: dietary regimen
|
| Outcome Measures: |
Primary: HbA1c and Incidence of hypoglycemia, After 24 weeks of treatment | Secondary: Postprandial glucose from 8-point SMBG spontaneously reported adverse events; any changes from baseline
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
4877
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-10
|
| Completion Date: |
2006-06
|
| Results First Posted: |
|
| Last Update Posted: |
2023-11-02
|
| Locations: |
Novo Nordisk Clinical Trial Call Center, Princeton, New Jersey, 08540, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00101751
|
