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

NCT00353587 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy Study of Metaglidasen in Type 2 Diabetes in Patients Suboptimally Controlled on Insulin

A Phase 2 study of Type 2 Diabetes, sponsored by Gilead Sciences.

Completed
Registry status
Phase 2
Development phase
396
Enrollment target
20
Study locations

NCT00353587 is a Phase 2 study of Type 2 Diabetes that has completed, run by Gilead Sciences. The registered enrollment target is 396 participants, below the 1,101-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 10 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00353587, a Phase 2 study of Type 2 Diabetes, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 2
Development phase
396 participants
Enrollment target
20
Study locations

Study Summary

This is a multicenter, randomized, double-blind, placebo- and active comparator-controlled phase 2/3 study of three dose levels of MBX-102 (200, 400, 600 mg) given orally to patients with type 2 diabetes receiving concomitant therapy with insulin. Eligible patients will be adults with type 2 diabetes who are taking intermediate- and/or long-acting insulin or pre-mixed (e.g., "70/30") insulin, or a combination of insulin and one or two non-TZD hypoglycemic agents including sulfonylurea, metformin, acrabose or Byetta, but who are poorly controlled on their existing therapy. Preference for enrollment will be given to patients on insulin monotherapy. Patients treated with a combination of insulin and other hypoglycemic agent(s) must be willing and able to discontinue and washout of the hypoglycemic agent(s) for the entire duration of the study (in toto, approximately 28 weeks). Patients who are taking fixed doses of a short-acting insulin (e.g., not a "sliding scale") in combination with intermediate-acting insulin may qualify for the study if both the patient and investigator are willing to either change to pre-mixed insulin (e.g., 70/30) or discontinue use of the short acting insulin for at least 26 weeks. Patients treated with a sliding scale of short-acting insulin will not be eligible for enrollment.

Conditions Studied

Type 2 Diabetes

Interventions

  • DRUG Placebo
  • DRUG Actos
  • DRUG MBX-102

Study Locations (20)

Texas

  • Dallas Diabetes & Endocrine Center - Dallas
  • Mercury Pharma Services - Houston
  • Diabetes Center of the Southwest - Midland
  • Diabetes & Glandular Disease Research Associates, P.A. - San Antonio

California

  • Associated Pharmaceutical Research Center, Inc. - Buena Park
  • The Intermed Group - Los Angeles
  • LAC/USC Medical Center - Los Angeles

Florida

  • International Research Associates, LLC - Miami
  • Suncoast Clinical Research, Inc. - Palm Harbor
  • Andres Patron DO PA - Pembroke Pines

Illinois

  • Cedar-Crosse Research Center - Chicago
  • Clinical Investigation Specialists, Inc. - Gurnee

Virginia

  • McGuire VA Medical Center - Richmond
  • National Clinical Research - Richmond

Other

  • Consultorio Integral de Atencion al Diabetico (CIAD) - Buenos Aires
  • CIMEL - Buenos Aires

Arkansas

  • NEA Clinic - Jonesboro

Mississippi

  • Olive Branch Research - Olive Branch

Trial Details

FieldValue
Enrollment Target 396 participants
Start Date 2006-05
Est. Completion 2007-11
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00353587

The ClinicalTrials.gov registry entry for NCT00353587 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 396 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,101-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (64% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00353587 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Texas, California, Florida.

Frequently Asked Questions

What is clinical trial NCT00353587 about?

NCT00353587 is a clinical study titled "Safety and Efficacy Study of Metaglidasen in Type 2 Diabetes in Patients Suboptimally Controlled on Insulin". This is a multicenter, randomized, double-blind, placebo- and active comparator-controlled phase 2/3 study of three dose levels of MBX-102 (200, 400, 600 mg) given orally to patients with type 2 diabetes receiving concomitant therapy with insulin. Eligible patients will be adults with type 2 diabete...

What is the current status of trial NCT00353587?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 396 participants. The study started on 2006-05. Estimated completion is 2007-11.

What conditions does trial NCT00353587 study?

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

What interventions are being tested in trial NCT00353587?

The interventions under investigation include: Placebo (DRUG), Actos (DRUG), MBX-102 (DRUG).

Who is sponsoring clinical trial NCT00353587?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00353587 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Illinois, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Type 2 Diabetes

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.

Explore more on PlainTrial

Type 2 Diabetes

All registered trials for this condition

Arkansas

All trials with a study site in Arkansas

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
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.