Conditions: Diabetes
Keywords: Diabetes Type 2 Diabetes Diabetes Mellitus Metabolic Diseases Glucose Metabolism Disorders Glycemic Control
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 101
Healthy volunteers: no

Brief summary:
This study is an extension of a study that has been ongoing for 1 year. The purpose of this open label study is to see the how well type 2 diabetics respond to VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an extended period of time. All subjects eligible to enroll into this study will receive study drug.

Detailed description:

Arms:
arm 1: Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067) arm 2: Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)

Interventions: intervention 1: VI-0521
Intervention descriptions: intervention 1: Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks

Protocol document: