A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.
Public ClinicalTrials.gov record NCT00316758. 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
A Multi-center, Open Label, Extension Study to Evaluate the Long-term Safety and Tolerability of GK Activator (2) in Type 2 Diabetic Patients From Studies BM18248 or BM18249
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study identification
- NCT ID
- NCT00316758
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 259 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 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
- Jan 31, 2006
- Primary completion
- Sep 30, 2007
- Completion
- Sep 30, 2007
- Last update posted
- Nov 1, 2016
2006 – 2007
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Chula Vista | California | 91910 | — |
| Not listed | Chula Vista | California | 91911 | — |
| Not listed | Los Angeles | California | 90057 | — |
| Not listed | Spring Valley | California | 91978 | — |
| Not listed | West Hills | California | 91307 | — |
| Not listed | Hollywood | Florida | 33021 | — |
| Not listed | Kissimmee | Florida | 34741 | — |
| Not listed | Atlanta | Georgia | 30308 | — |
| Not listed | Arkansas City | Kansas | 67005 | — |
| Not listed | Butte | Montana | 59701 | — |
| Not listed | Binghamton | New York | 13901 | — |
| Not listed | Fayetteville | North Carolina | 28304 | — |
| Not listed | Statesville | North Carolina | 28625 | — |
| Not listed | Winston-Salem | North Carolina | 27103 | — |
| Not listed | Springdale | Ohio | 45246 | — |
| Not listed | Oklahoma City | Oklahoma | 73112 | — |
| Not listed | Medford | Oregon | 97504 | — |
| Not listed | Beaver | Pennsylvania | 15009 | — |
| Not listed | Mt. Pleasant | South Carolina | 29464 | — |
| Not listed | Memphis | Tennessee | 38119 | — |
| Not listed | Federal Way | Washington | 98003 | — |
| Not listed | Renton | Washington | 98055 | — |
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 36 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00316758, 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 Nov 1, 2016 · Synced Sep 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00316758 live on ClinicalTrials.gov.