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NCT00101751 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 4
Development phase
4,877
Enrollment target
1
Study location

NCT00101751: Completed Phase 4 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.

NCT00101751 is a Phase 4 study of Diabetes Mellitus, Type 2 and Diabetes that has completed, run by Novo Nordisk A/S. The registered enrollment target is 4,877 participants, roughly in line with the 4,471-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00101751, a Phase 4 study of Diabetes Mellitus, Type 2 and Diabetes, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 4
Development phase
4,877 participants
Enrollment target
1
Study location

Study 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

  • DRUG biphasic insulin aspart
  • BEHAVIORAL dietary regimen

Study Locations (1)

New Jersey

  • Novo Nordisk Clinical Trial Call Center - Princeton

Trial Details

FieldValue
Enrollment Target 4,877 participants
Start Date 2004-10
Est. Completion 2006-06
Phase Phase 4
Novo Nordisk A/S

431 total trials

What the finished NCT00101751 record still lists

NCT00101751 is an interventional study that assigns participants to a tested intervention. Its 4,877 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 4,471-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target.

The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which biphasic insulin aspart is the first listed.

NCT00101751 reports a single indexed study location in New Jersey.

Frequently Asked Questions

What is clinical trial NCT00101751 about?

NCT00101751 is a clinical study titled "INITIATE Plus (INITiation of Insulin to Reach A1c TargEt) Study". 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.

What is the current status of trial NCT00101751?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 4,877 participants. The study started on 2004-10. Estimated completion is 2006-06.

What conditions does trial NCT00101751 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes.

What interventions are being tested in trial NCT00101751?

The interventions under investigation include: biphasic insulin aspart (DRUG), dietary regimen (BEHAVIORAL).

Who is sponsoring clinical trial NCT00101751?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00101751 being conducted?

This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Diabetes Mellitus, Type 2

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00101751's enrollment target sits among peer trials

4,877 16th of 348 higher than 333 of 348 other Diabetes Mellitus, Type 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00101751, the US trial registry maintained by the National Library of Medicine. NCT00101751 (large enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.