INITIATE Plus (INITiation of Insulin to Reach A1c TargEt) Study

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00101751
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-01-12
• Study First Submitted QC: 2005-01-12
• Study First Posted: 2005-01-13
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4877

Inclusion Criteria

• Type 2 Diabetes

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c and Incidence of hypoglycemia	After 24 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Postprandial glucose from 8-point SMBG spontaneously reported adverse events; any changes from baseline

Trial Locations

Locations (1)

Novo Nordisk Clinical Trial Call Center; 🇺🇸 Princeton, New Jersey, United States