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NCT00484419 · ClinicalTrials.gov registry record · Phase 3

Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin

A Phase 3 study of Type 2 Diabetes and Hyperlipidemia, sponsored by Daiichi Sankyo.

Completed
Registry status
Phase 3
Development phase
169
Enrollment target
20
Study locations

NCT00484419 is a Phase 3 study of Type 2 Diabetes and Hyperlipidemia that has completed, run by Daiichi Sankyo. The registered enrollment target is 169 participants, below the 1,102-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT00484419, a Phase 3 study of Type 2 Diabetes and Hyperlipidemia, has completed, sponsored by Daiichi Sankyo.

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

Study Summary

A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.

Interventions

  • DRUG Colesevelam HCl
  • DRUG rosiglitazone maleate
  • DRUG sitagliptin phosphate

Study Locations (20)

California

  • - La Mesa
  • - Los Angeles
  • - Los Gatos
  • - San Antonio

Michigan

  • - Dearborn
  • - West Bloomfield

North Carolina

  • - Lexington
  • - Winston-Salem

Ohio

  • - Munroe Falls
  • - Zaneville

Florida

  • - Chiefland

Indiana

  • - Gary

Maryland

  • - Baltimore

Nevada

  • - Las Vegas

Trial Details

FieldValue
Enrollment Target 169 participants
Start Date 2007-05
Est. Completion 2008-04
Phase Phase 3

Sponsor

Daiichi Sankyo

236 total trials

What the Registry Record Tells You About NCT00484419

The ClinicalTrials.gov registry entry for NCT00484419 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,102-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (85% lower). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Type 2 Diabetes appearing as the primary indexed condition, and to 3 interventions - of which Colesevelam HCl is the first listed.

NCT00484419 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Michigan, North Carolina.

Frequently Asked Questions

What is clinical trial NCT00484419 about?

NCT00484419 is a clinical study titled "Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin". A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.

What is the current status of trial NCT00484419?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 169 participants. The study started on 2007-05. Estimated completion is 2008-04.

What conditions does trial NCT00484419 study?

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

What interventions are being tested in trial NCT00484419?

The interventions under investigation include: Colesevelam HCl (DRUG), rosiglitazone maleate (DRUG), sitagliptin phosphate (DRUG).

Who is sponsoring clinical trial NCT00484419?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00484419 being conducted?

This trial has 20 study locations across California, Florida, Indiana, Maryland, Michigan. 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

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