INITIATE Plus (INITiation of Insulin to Reach A1c TargEt) Study
NCT00101751 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4877
Last updated 2023-11-02
Summary
This trial is conducted in the United States of America (USA). The purpose of this study is to compare the effectiveness and safety of a biphasic insulin aspart standard titration regimen when coupled with dietary intervention to standard titration without dietary intervention.
Conditions
- Diabetes
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
biphasic insulin aspart
- BEHAVIORAL
-
dietary regimen
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-10-31
- Primary Completion
- 2006-06-30
- Completion
- 2006-06-30
Countries
- United States
Study Locations
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