Diabetes
Conditions
Keywords
Diabetes, Type 2 Diabetes, Diabetes Mellitus, Metabolic Diseases, Glucose Metabolism Disorders, Glycemic Control
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.
Interventions
DRUGVI-0521
Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks
Sponsors
Synteract, Inc.
Sentrx
VIVUS LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c From Baseline to Week 72 | Baseline to 72 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent Weight Change From Baseline to Week 72 | Baseline to 72 weeks |
Countries
United States
Participant flow
Recruitment details
This is an extension study to OB-202 (NCT00486291) and DM-230 (NCT00600067)
Participants by arm
| Arm | Count |
|---|---|
| 16-week Population subjects who were randomized to placebo in previous study | 44 |
| 72-week Population subjects who were randomized to active during previous study | 57 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | protocol non-compliance | 0 | 1 |
| Overall Study | Study terminated by sponsor | 44 | 55 |
Baseline characteristics
| Characteristic | 16-week Population | 72-week Population | Total |
|---|---|---|---|
| Age Continuous | 50.2 years STANDARD_DEVIATION 8.6 | 49.5 years STANDARD_DEVIATION 7 | 49.8 years STANDARD_DEVIATION 7.7 |
| Region of Enrollment United States | 44 participants | 57 participants | 101 participants |
| Sex: Female, Male Female | 25 Participants | 48 Participants | 73 Participants |
| Sex: Female, Male Male | 19 Participants | 9 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 44 | 34 / 57 |
| serious Total, serious adverse events | 1 / 44 | 0 / 57 |
Outcome results
Primary
Change in HbA1c From Baseline to Week 72
Time frame: Baseline to 72 weeks
Population: Intent-to-treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 16-week Population | Change in HbA1c From Baseline to Week 72 | -0.5 percent change | Standard Deviation 0.79 |
| 72-week Population | Change in HbA1c From Baseline to Week 72 | -1.4 percent change | Standard Deviation 1.34 |
Secondary
Percent Weight Change From Baseline to Week 72
Time frame: Baseline to 72 weeks
Population: Intent-to-treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 16-week Population | Percent Weight Change From Baseline to Week 72 | -5.7 percent change | Standard Deviation 4.64 |
| 72-week Population | Percent Weight Change From Baseline to Week 72 | -10.1 percent change | Standard Deviation 8.7 |