Safety and Efficacy Study of Metaglidasen in Type 2 Diabetes in Patients Suboptimally Controlled on Insulin
Public ClinicalTrials.gov record NCT00353587. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 2/3, Randomized, Double-blind, Placebo- and Active Comparator-controlled, Parallel, Multicenter Study to Determine Safety and Efficacy of Metaglidasen in Treatment of Type 2 Diabetes Suboptimally Controlled on Insulin
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00353587
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 396 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2006
- Primary completion
- Oct 31, 2007
- Completion
- Oct 31, 2007
- Last update posted
- Apr 30, 2015
2006 – 2007
United States locations
- U.S. sites
- 18
- U.S. states
- 9
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| NEA Clinic | Jonesboro | Arkansas | 72401 | — |
| Associated Pharmaceutical Research Center, Inc. | Buena Park | California | 90620 | — |
| The Intermed Group | Los Angeles | California | 90017 | — |
| LAC/USC Medical Center | Los Angeles | California | 90033 | — |
| International Research Associates, LLC | Miami | Florida | 33156 | — |
| Suncoast Clinical Research, Inc. | Palm Harbor | Florida | 34684 | — |
| Andres Patron DO PA | Pembroke Pines | Florida | 33026 | — |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | — |
| Clinical Investigation Specialists, Inc. | Gurnee | Illinois | 60031 | — |
| Olive Branch Research | Olive Branch | Mississippi | 38654 | — |
| Optimed Research, LLC | Columbus | Ohio | 43235 | — |
| Radiant Research - Greer | Greer | South Carolina | 29651 | — |
| Dallas Diabetes & Endocrine Center | Dallas | Texas | 75230 | — |
| Mercury Pharma Services | Houston | Texas | 77081 | — |
| Diabetes Center of the Southwest | Midland | Texas | 79705 | — |
| Diabetes & Glandular Disease Research Associates, P.A. | San Antonio | Texas | 78229 | — |
| McGuire VA Medical Center | Richmond | Virginia | 23249 | — |
| National Clinical Research | Richmond | Virginia | 23294 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 49 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00353587, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 30, 2015 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00353587 live on ClinicalTrials.gov.