Safety and Efficacy of BGP-15 in Patients With Type 2 Diabetes Mellitus
Public ClinicalTrials.gov record NCT01069965. 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
Randomized, Double-blind, Placebo-controlled, Parallel Group, Multiple Dose, Multicenter Study to Assess Safety & Efficacy of BGP-15 Administered Orally 1 or 2 Times Daily With Metformin & Sulfonylurea or Metformin in T2 Diabetic Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a safety and dose finding efficacy study to evaluate the effects of BGP-15 over the dose range of 100 mg/day to 400 mg/day. Doses are applied once or twice a day for 13 weeks as add-on therapy to the combination of metformin and sulfonylurea treatment or metformin alone in patients with Type 2 Diabetes Mellitus.
Study identification
- NCT ID
- NCT01069965
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 196 participants
Conditions and interventions
Conditions
Interventions
- BGP-15 100 mg QD Drug
- BGP-15 100 mg BID Drug
- Placebo BID Drug
- BGP-15 200 mg QD Drug
- BGP-15 200 mg BID Drug
- BGP-15 400 mg QD Drug
Drug
Eligibility (public fields only)
- Age range
- 30 Years to 70 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
- Oct 2010 (Type not available)
- Primary completion
- Aug 2011 (Actual)
- Completion
- Oct 2011 (Actual)
- Last update posted
- Sep 29, 2014
2010 – 2011
United States locations
- U.S. sites
- 20
- U.S. states
- 12
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Andrew J. Lewin Medical Corporation DBA National Research Institute | Los Angeles | California | 90057 | — |
| Center for Clinical Trials, LLC. | Paramount | California | 90723 | — |
| Orange County Research Center | Tustin | California | 92780 | — |
| Creekside Endocrine Associates PC | Denver | Colorado | 80209 | — |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | — |
| Metabolic Research Institute, Inc. | West Palm Beach | Florida | 33401 | — |
| Atlanta Pharmaceutical Research | Decatur | Georgia | 30033 | — |
| ICCT Research International, Inc. | Chicago | Illinois | 60611 | — |
| Medstar Health Research Institute | Hyattsville | Maryland | 20782 | — |
| The Center for Pharmaceutical Research, P.C. | Kansas City | Missouri | 64114 | — |
| Nevada Alliance Against Diabetes | Las Vegas | Nevada | 89101 | — |
| New Hanover Medical Research | Wilmington | North Carolina | 28401 | — |
| Piedmont Medical Research, LLC. | Winston-Salem | North Carolina | 27103 | — |
| Upstate Pharmaceutical Research | Greenville | South Carolina | 29615 | — |
| Mountain View Clinical Research | Greer | South Carolina | 29651 | — |
| Southeastern Research Associates, Inc. | Taylors | South Carolina | 29687 | — |
| Athens Medical Group | Athens | Tennessee | 37303 | — |
| Juno Research, LLC. | Houston | Texas | 77074 | — |
| Juno Research, LLC. | Katy | Texas | 77451 | — |
| Cetero Research-San Antonio | San Antonio | Texas | 78229 | — |
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 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01069965, 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 Sep 29, 2014 · Synced Oct 21, 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 public registry record, listed eligibility criteria, and available contact information for NCT01069965 live on ClinicalTrials.gov.