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NCT00751114 · ClinicalTrials.gov registry record · Phase 4

Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients

A Phase 4 study of Diabetes Mellitus, Type 2, sponsored by Sanofi.

Completed
Registry status
Phase 4
Development phase
515
Enrollment target
17
Study locations

NCT00751114 is a Phase 4 study of Diabetes Mellitus, Type 2 that has completed, run by Sanofi. The registered enrollment target is 515 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (89% lower). The trial reports 17 study locations across 2 states.

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The verdict

NCT00751114, a Phase 4 study of Diabetes Mellitus, Type 2, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 4
Development phase
515 participants
Enrollment target
17
Study locations

Study Summary

The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period. Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on: * HbA1c level * Fasting Plasma Glucose (FPG) * 7-point plasma glucose (PG) profiles * Percentage of patients with HbA1c \<7% and \<6.5% Safety objectives consisted of: * Hypoglycemia occurrence * Body weight * Overall safety

Conditions Studied

Diabetes Mellitus, Type 2

Interventions

  • DRUG Metformin
  • DRUG Sitagliptin
  • DRUG Insulin Glargine

Study Locations (17)

Other

  • Sanofi-Aventis Administrative Office - Vienna
  • Sanofi-Aventis Administrative Office - São Paulo
  • Sanofi-Aventis Administrative Office - Bogotá
  • Sanofi-Aventis Administrative Office - Cairo
  • Sanofi-Aventis Administrative Office - Kallithea
  • Sanofi-Aventis Administrative Office - Hong Kong
  • Sanofi-Aventis Administrative Office - Mumbai
  • Sanofi-Aventis Administrative Office - Netanya
  • Sanofi-Aventis Administrative Office - Beirut
  • Sanofi-Aventis Administrative Office - Col. Coyoacan
  • Sanofi-Aventis Administrative Office - Gouda
  • Sanofi-Aventis Administrative Office - Porto Salvo
  • Sanofi-Aventis Administrative Office - Seoul
  • Sanofi-Aventis Administrative Office - Barcelona
  • Sanofi-Aventis Administrative Office - Istanbul
  • Sanofi-Aventis Administrative Office - Guildford Surrey

New Jersey

  • Sanofi-Aventis Administrative Office - Bridgewater

Trial Details

FieldValue
Enrollment Target 515 participants
Start Date 2008-11
Est. Completion 2011-07
Phase Phase 4

Sponsor

Sanofi

713 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00751114

The ClinicalTrials.gov registry entry for NCT00751114 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 515 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (89% 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 3 interventions - of which Metformin is the first listed.

NCT00751114 reports 17 study locations spanning 2 distinct geographic areas - top geographies include Other, New Jersey.

Frequently Asked Questions

What is clinical trial NCT00751114 about?

NCT00751114 is a clinical study titled "Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients". The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period. Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on: * HbA1...

What is the current status of trial NCT00751114?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 515 participants. The study started on 2008-11. Estimated completion is 2011-07.

What conditions does trial NCT00751114 study?

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

What interventions are being tested in trial NCT00751114?

The interventions under investigation include: Metformin (DRUG), Sitagliptin (DRUG), Insulin Glargine (DRUG).

Who is sponsoring clinical trial NCT00751114?

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

Where is trial NCT00751114 being conducted?

This trial has 17 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 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.