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NCT00653341 · ClinicalTrials.gov registry record · Phase 3

Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)

A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
764
Enrollment target
2
Study locations

NCT00653341 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Sanofi. The registered enrollment target is 764 participants, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00653341, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
764 participants
Enrollment target
2
Study locations

Study Summary

The primary objective of this study is to compare the percentage of subjects who reach the target HbA1c level (\< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during treatment with insulin glargine or NPH human insulin.

Conditions Studied

Interventions

  • DRUG insulin glargine
  • DRUG NPH human insulin

Study Locations (2)

New Jersey

  • Sanofi-aventis administrative office - Bridgewater

Other

  • Sanofi-aventis administrative office - Laval

Trial Details

FieldValue
Enrollment Target 764 participants
Start Date 2000-01
Est. Completion 2001-10
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00653341

The ClinicalTrials.gov registry entry for NCT00653341 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 764 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (83% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which insulin glargine is the first listed.

NCT00653341 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New Jersey, Other.

Frequently Asked Questions

What is clinical trial NCT00653341 about?

NCT00653341 is a clinical study titled "Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)". The primary objective of this study is to compare the percentage of subjects who reach the target HbA1c level (\< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during treatment with insulin glargine or NPH human insulin.

What is the current status of trial NCT00653341?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 764 participants. The study started on 2000-01. Estimated completion is 2001-10.

What conditions does trial NCT00653341 study?

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

What interventions are being tested in trial NCT00653341?

The interventions under investigation include: insulin glargine (DRUG), NPH human insulin (DRUG).

Who is sponsoring clinical trial NCT00653341?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00653341 being conducted?

This trial has 2 study locations 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

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.