drugset / Trial / NCT01069965
Safety and Efficacy of BGP-15 in Patients With Type 2 Diabetes Mellitus
Phase 2
Terminated
196 enrolled
N-Gene Research Laboratories, Inc.
Barc NV · collabHaupt Pharma Wülfing GmbH · collabIntegrium · collabKinexum LLC · collabMsource Medical Development GmbH · collabThermo Fisher Scientific, Inc · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2010-10
- Primary completion
- 2011-08
- Completion
- 2011-10
Outcome
Outcome not reported
Stopped (Business): “Funding support withdrawn.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BGP-15 | Small molecule | 100 mg | Oral |
| Subject | BGP-15 | Small molecule | 200 mg | Oral |
| Subject | BGP-15 | Small molecule | 400 mg | Oral |