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

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Diabetes Mellitus, Type 2

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
Sanofi

713 total trials

What the finished NCT00653341 record still lists

NCT00653341 is an interventional study that assigns participants to a tested intervention. The registered 764 participants enrollment target is mid-sized for trials with a published cap, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (83% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

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 NCT00653341's enrollment target sits among peer trials

764 48th of 348 higher than 301 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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Related registry views

Source: ClinicalTrials.gov NCT00653341, the US trial registry maintained by the National Library of Medicine. NCT00653341 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.