Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00754988 · ClinicalTrials.gov registry record · Phase 3

A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.

A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
666
Enrollment target
20
Study locations

NCT00754988 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Hoffmann-La Roche. The registered enrollment target is 666 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 8 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00754988, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Hoffmann-La Roche.

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

Study Summary

This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.

Conditions Studied

Interventions

  • DRUG Metformin
  • DRUG Sitagliptin
  • DRUG Placebo (matching sitagliptin)
  • DRUG Placebo (matching taspoglutide)
  • DRUG Taspoglutide

Study Locations (20)

California

  • - Huntington Beach
  • - La Jolla
  • - Los Angeles
  • - Roseville
  • - San Francisco
  • - Tacoma

Florida

  • - Daytona Beach
  • - Hialeah
  • - Jacksonville
  • - Miami
  • - Panama City
  • - Tampa

Alabama

  • - Birmingham
  • - Huntsville
  • - Tallassee

Arizona

  • - Scottsdale

Arkansas

  • - Little Rock

Colorado

  • - Colorado Springs

Connecticut

  • - New London

District of Columbia

  • - Manati

Trial Details

FieldValue
Enrollment Target 666 participants
Start Date 2008-10
Est. Completion 2011-03
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT00754988

The ClinicalTrials.gov registry entry for NCT00754988 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 666 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 Hoffmann-La Roche, which has 909 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 5 interventions - of which Metformin is the first listed.

NCT00754988 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Alabama.

Frequently Asked Questions

What is clinical trial NCT00754988 about?

NCT00754988 is a clinical study titled "A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.". This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 wee...

What is the current status of trial NCT00754988?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 666 participants. The study started on 2008-10. Estimated completion is 2011-03.

What conditions does trial NCT00754988 study?

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

What interventions are being tested in trial NCT00754988?

The interventions under investigation include: Metformin (DRUG), Sitagliptin (DRUG), Placebo (matching sitagliptin) (DRUG), Placebo (matching taspoglutide) (DRUG), Taspoglutide (DRUG).

Who is sponsoring clinical trial NCT00754988?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00754988 being conducted?

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

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.

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.