A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults

Vivus

Status and phase: Completed; Phase 2

Conditions: Diabetes

Treatments: Drug: Phentermine/Topiramate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00600067

DM-230

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have completed the qualifying OB-202 trial
• If females of child-bearing potential, subjects must be using adequate contraception
• Provide written informed consent
• Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures

Exclusion criteria

• Subjects who have developed one or more morbidities during the OB-202 trial that would pose a safety concern

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Phentermine/Topiramate

2

Placebo Comparator group

Treatment:

Drug: Placebo