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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 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.

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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.

Conditions Studied

Diabetes Mellitus, Type 2 Diabetes

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

Sponsor

Novo Nordisk A/S

431 total trials

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What the Registry Record Tells You About NCT00101751

The ClinicalTrials.gov registry entry for NCT00101751 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 4,877 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 4,471-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.