Conditions: Diabetes
Keywords: Diabetes Type 2 Diabetes Diabetes Mellitus Metabolic Diseases Glucose Metabolism Disorders Glycemic Control
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

Brief summary:
The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Phentermine/Topiramate intervention 2: Placebo
Intervention descriptions: intervention 1: phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks intervention 2: Oral placebo capsules, once daily, 28 weeks

Protocol document: