Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults

Vivus

Status and phase: Terminated; Phase 2

Conditions: Diabetes

Treatments: Drug: VI-0521

Study type: Interventional

Funder types: Industry

Identifiers

NCT00737633

DM-231

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have completed the qualifying DM-230 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
• Be greater than 80% compliant in study medication use during the last three visits for DM-230

Exclusion criteria

• Subjects who have developed one or more morbidities during the DM-230 trial that would pose a safety concern

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

16-Week population

Experimental group

Description:

Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)

Treatment:

Drug: VI-0521

72-Week population

Experimental group

Description:

Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)

Treatment:

Drug: VI-0521