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

Efficacy and Safety of a Standard Titration Algorithm Coupled With a Conventional Dietary Intervention or Intensive Dietary Intervention Versus a Standard Titration Algorithm, Alone, in Patients With Type 2 Diabetes Initiating NovoLog® Mix 70/30 Therapy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00101751

Acronym

INITIATE plus

Enrollment

4877

Registered

2005-01-13

Start date

2004-10-31

Completion date

2006-06-30

Last updated

2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGbiphasic insulin aspart

BEHAVIORALdietary regimen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 2 Diabetes

Design outcomes

Primary

Measure	Time frame
HbA1c and Incidence of hypoglycemia	After 24 weeks of treatment

Secondary

Measure	Time frame
Postprandial glucose from 8-point SMBG spontaneously reported adverse events; any changes from baseline	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026