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NCT00700817 · ClinicalTrials.gov registry record · Phase 3

The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

A Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 3
Development phase
665
Enrollment target
20
Study locations

NCT00700817 is a Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes that has completed, run by Novo Nordisk A/S. The registered enrollment target is 665 participants, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT00700817, a Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
665 participants
Enrollment target
20
Study locations

Study Summary

This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone. The trial has been extended by 52 weeks. The extension will consist of two 26-week periods: 1. Week 27-52 after randomisation \- All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen. 2. Week 53-78 after randomisation * Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals. * Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.

Interventions

  • DRUG metformin
  • DRUG liraglutide
  • DRUG sitagliptin

Study Locations (20)

California

  • Novo Nordisk Investigational Site - Escondido
  • Novo Nordisk Investigational Site - Fresno
  • Novo Nordisk Investigational Site - Huntington Beach
  • Novo Nordisk Investigational Site - Long Beach
  • Novo Nordisk Investigational Site - Northridge
  • Novo Nordisk Investigational Site - Orange
  • Novo Nordisk Investigational Site - Poway
  • Novo Nordisk Investigational Site - Walnut Creek

Florida

  • Novo Nordisk Investigational Site - Crystal River
  • Novo Nordisk Investigational Site - Jacksonville
  • Novo Nordisk Investigational Site - Jacksonville
  • Novo Nordisk Investigational Site - Miami
  • Novo Nordisk Investigational Site - Ocala
  • Novo Nordisk Investigational Site - Panama City
  • Novo Nordisk Investigational Site - Saint Cloud

Georgia

  • Novo Nordisk Investigational Site - Athens
  • Novo Nordisk Investigational Site - Atlanta
  • Novo Nordisk Investigational Site - Dunwoody

Alabama

  • Novo Nordisk Investigational Site - Birmingham

Colorado

  • Novo Nordisk Investigational Site - Denver

Trial Details

FieldValue
Enrollment Target 665 participants
Start Date 2008-06
Est. Completion 2010-06
Phase Phase 3

Sponsor

Novo Nordisk A/S

431 total trials

What the Registry Record Tells You About NCT00700817

The ClinicalTrials.gov registry entry for NCT00700817 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 665 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 (85% lower). 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 3 interventions - of which metformin is the first listed.

NCT00700817 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT00700817 about?

NCT00700817 is a clinical study titled "The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus". This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone. The trial has been extended by...

What is the current status of trial NCT00700817?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 665 participants. The study started on 2008-06. Estimated completion is 2010-06.

What conditions does trial NCT00700817 study?

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

What interventions are being tested in trial NCT00700817?

The interventions under investigation include: metformin (DRUG), liraglutide (DRUG), sitagliptin (DRUG).

Who is sponsoring clinical trial NCT00700817?

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

Where is trial NCT00700817 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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